oversight

Cost of Spinal Cord Injuries in the United States and Progress in Spinal Cord Regeneration

Published by the Government Accountability Office on 1977-10-14.

Below is a raw (and likely hideous) rendition of the original report. (PDF)

                          DCCUMENT PESUME
03758 - [B2934205]
Cost of Spinal Cord Injuries in the United States and Progress
in Spinal Cord Regeneration. HRD-78-10; B-164031(2). October 14,
1977. 42 pp.
Staff study.
Issue Area: Health Programs (1200).
Contact: Susan Resources Div.
Budget Function: Health: health Research anri Education (552).
Organi7aticn Concerned: Department of Health, Education, and
    Welfare; Veterans Administraticm.
         A study was conducted of spinal cord injury costs in
the United States and current research efforts involving spinal
cord regeneration. The consequences of a spinal cord injury
range from partial paralysis to death. A victim who survives
incurs lifetime medical costs that can range between $44,000 to
$115,000 depending on the extent of the injury, not to mention
the lost earnings and other injury related costs. Advances have
been made in diagnosing spinal cord injuries and treating damage
to the cord caused by pressure on the spine. However, once the
cord's nerve fibers are   e jtroyed, function below the level of
the injury is usually lost and no treatment available can
regenerate nerve fibers. Regenerati:n research to date has not
been successful in regrowing nerve fibers in humans for numerous
reasons. many Federal agencies are bsudying the pLoblem with no
central direction and are supporting various approaches to solve
the problem. In England special centers have been developed to
treat spinal cord injuries and the concept has been accepted
throughout Europe. (Author)
        STUDY BY THE STAFF
 ~~~             THE
                ~OF
U.S. GENERAL ACCOUNTING OFFICE



Cost Of Spinal Cord Injuries
In The United States And
Progress In Spinal Cord Regeneration
The consequences of a spinal cord injury can be
devastating- from partial paralysis to death. A victim
who survves Incurs lifetlnm medical costs that can
range between $44,000 to $115,000 depending on
the extent of the injury, not to menticn the lost
earnings and other injury related costs.
Advances have been made in diagnosing spinal cord
injuries and treating damage to the cord caused by
pressure on the spine. However o--; the cord's nerve
fibers are destroyed, function below the :evel of the
injury is usually lost and no treatment available can
regenerate nere fibers.
In England, special centers were developed to treat
spinal cord injuries and the concept has been
accepted throughout Europe. This concept consists of
establishing acute spinal cord injury centers
throughout the country staffed with a
multi-disciplined team of medical specialists. This
approach should be more widely used in the United
States, according to medical authorities, while
research on regenerating the spinal cord continues.
Regeneration research to date has not been successful
in regrowing nerve fibers in humans for numerous
reasons Many Federal .aencies are studying the
problem with no central direction and are supporting
various approachds to solve the problem.


mD-3o1O                                          OCTOBER 14, 1977
                          Con tents
                                                       Page
CHAPTER

  1       INTRODUCTION                                   1
               Nature of spinal cord injury              2
               Consequences of spinal cord injury        4

  2       EXTENT AND CAUSES OF SPINAL CORD INJURY        8
               Incidence and prevalence                  8
               Causes                                    8

  3       METHODS OF TRPATING SPINAL CORD INJURY        10
               Diagnostic advances                      10
               Treatment of injury related problems     10
               Treatment of spinal cord injury          12
               Acute spinal cord injury centers         13

  4       COSTS OF SPINAL CORD INJURIES                 17
               Cost components                          18
               Direct costs                             19

  5       PROGRESS AND PROBLEMS IN SPINAL CORD
            INJURY AND REGENERATION RESEARCH            26
               Projects funded on spinal cord injury
                 and regeneration research              26
               Spinal cord injury research              29
               Regeneration research .in the
                 United States                          31
               Regeneration research in the
                 Soviet Union                           35
               Prospects for a breakthrough in
                 spinal cord regeneration               38
               Computer by-pass approach                38

  6       TRAINING AND COORDINATION                     41
               Training                                 41
               Coordination efforts                     41
                ABBREVIATIONS

GAO      General Accounting Office
IIHS     Insurance Institute for Highway Safety
NIH      National Institutes of Health
NINCDS   National Institute for Neurological and
           Communicative Disorders and Stroke
NPF      National Paraplegia Foundation
NYU      New York University
PVA      Paralyzed Veterans of America
RSA      Rehabilitation Services Administration
SCI      Spinal Cord Injury
VA       Veterans Administration
                          CHAPTER 1
                        INTRODUCTION
     In a letter dated October 8, 1976, five members of the
Congress from Oregon requested that GAO conduct a study of
spinal cord injury (SCI) costs in the United States and
current research efforts involving spinal cord regeneration.
We agreed that we would examine other aspects of traumatic
spinal cord injuries including annual incidence, prevalence,
and causes of such injuries; progress and problems in
treatment; the status of efforts to regenerate the human
spinal cord after injury; vnd coordination efforts among
the various Federal organizations involved in research
in this area.

     This staff study included reviewing studies, reported
on in the literature, and interviewing officials of the
following organizations:
     Federal Agencies and Depa-tments
    Department of the Army
    Department of the Navy
    National Aeronautics and Space Administration
    National Institutes of Health
    National Science Foui.dation
    Rehabilitation Services Administration
    Veterans Administration
     Private Organizations, Medical Schools, and Hospitals
    Insurance Institute for Highway Safety
    Institute for Rehabilitation Medicine
    National Paraplegia Foundation
    Paralyzed Veterans of America
    Bellevue Hospital Acute Spinal Cord Injury Center
    Case-Western Reserve University
    Cornell University Medical School
    Johns Hopkins University Medical School
    Medical University of South Carolina
    New York University Medical Center
    Ohio State University Acute Spinal Cord Injury Center
    Rancho Los Amigos Hospital
    University of Maryland Medical School
    University of Michigan
    University ot Texas Medical Schocl
    University of Wisconsin Medical School
     We also visited acute SCI centers at Bellevue Hospital,
New York, New York and the Veterans Administration Hospital,
West Ruxbury, Massachusetts. Finally, to identify current
spinal cord injury and regeneration research projects, we
used data provided by the various Federal agencies and pri-
vate organizations.
NATURE OF SPINAL CORD INJURY

     The spinal cord and the brain make up the central ner-
vous system. The spinal cord is composed of approximately
100 million nerve fibers and cells and is about 17 inches
long. It connects the brain with the muscles, skin, and
internal organs.
     All important motor and sensory functions controlled by
nerve messages or impulses that originate in the brain tra-
vel along the nerve fibers in the spinal cord.
     As shown in figure 1, the spinal cord is divided into
31 segments (8 cervical or neck, 12 thoracic or chest and 11
lumbar or lower back) with nerve roots emerging from each
segment. These nerve roots carry messages to and from the
muscles or other parts of the body. Nerves which connect
the central nervous system to other parts of the body
make up the peripheral nervous system. Figure 1 also shows
the consequences of suffering an SCI by level of injury
or the cord.
     Internally, the spinal cord is composed of an Duter
white matter consisting of nerve fibers carrying impulses to
or from the brain and peripheral nerves, and an inner gray
matter made up of nerve cells. The gray matter has the
greatest metabolic activity and is the most sensitive to
injury.
     The gray matter is composed of nerve cells called
neurons. Each neuron consists of a cell body and one or more
threadlike projections that may reach a length of several
feet. Those projections that receive messages and carry them
towards the cell body are called dendrites and those that
carry them away from the cells are called axons (nerve
 fibers).  Nerve fibers which have a common origin and com-
mon destination are called nerve tracts.
     Nerve fibers terminate by branching into many fine fil-
aments called terminals. These terminals establish contact
with other cell bodies or organs at a junction called a syn-
apse. The function of the synapse is to transfer chemical



                               2
                                                                   Figure 1


                                                                   Corvical
                                                                      (C)



c:5 quadriplegia_
Peduced respiratory capacity. Patient
totally depencden: i.nothers. Wheel.        I              -           -.----....----.-
chair indispensable.                                               Thoracic
C7 quadriplegia                                                       (Th)
Reduced respiratory capacity. Patient
almost totally dependent on others. Wheel
chair Indispendable Need for splints and
other aids for the forearms and hands.

C8-Th 1 parapiegia-
Reduced respiratory capacity. Partial
dependence on others but only minimal
aid needed for personal care.
Wheel.chair indispensabie Crutch
gait possible with long leg braces.
pelvic bend with hip locks and with
or without a spinal brace, and two
crutches Possible to drive a car
fitted with hand controls and
automatic clutch.

Th 1-2 paraplega
Reduced respiratory capacity Com-
plete independence. Whee! chair in
dispensable. Crutch gait possible               ------
with long leg braces but not neces
sarilV a pelvic band, and crutches                                  Lumber
Possible to drive a car fined                                         (L)
with hand controls but not neces
sardly with an automat c clutch

Th 7 parapleg a
Complete Independence     Wheel-char
indispensable Crutch gat possblel
with long leg braces but not neces                       -------
'arilv a pelvic band, and crutches
Possible to drive a car fined
with hand controls.

Th 12 L1         egi
Complete independence Wheel-chair
indispensable. Crutch gait possible
with leg braces and crutches Pos
sible to drive a car with hand
controls.


Complete independence at home and
elsewhere. Wheel-chair not In
dispensable. Normal walking possible
with foot braces to counter drop
foot, crutches and sometimes knee
stabilizers. Possible to drive
a car fitted with hand controls
                I        I      '
C&uds lQuina
or electrical activity from the neuron to its target in or-
der to transfer the nerve impulse.

     The human spinal cord like the brain is unable to re-
place destroyed nerve cells. When a spinal nerve fiber is
damaged it is unable to cross the area of injury and re-
establish communication beyond the point of injury. This
is in contrast to tne peripheral nervous system where sev-
ered nerves can grow back and reestablish functional commu-
nication. The spinal cord, unlike s-me portions of the brain,
has no spare parts or alternate pathways so that undamaged
portions generally cannot take over or be trained to take
over the function of the damaged portion.
CONSEQUENCES 0   SPINAL CORD INJURY

     The consequences of spinal cord injury range from
partial paralysis to death. An SCI causes an interruption of
the nerve messages that are transmitted from the brain down
to the skin and muscles and vice versa. Thus, the portions
of the body below the level of the injury are left unfeel-
ing, and nonfunctional. Generally, the higher the injury on
the spinal cord, the greater the disability.

     There are two main categories of SCI, complete and in-
complete. Complete lesions are defined as those in which there
is a total paralysis of all muscles and a total loss of all
sensations below the level of injury. Incomplete lesions are
defined as those in which there is preservation of some vol-
untary movements or sensations below the level of injury.
According to NIH and VA officials, injuries to the spinal
cord rarely result in complete lesions, and persons sustain-
ing complete lesions rarely show improvement. Generally,
persons sustaining incomplete lesions have a better chance
for functional recovery.

     SCI victims are classified as either paraplegics or
quadriplegics. Victims whose lower extremities and abdominal
functions are affected are called paraplegics. Their injury
is at the thoracic level or below. Victims whose injury is
in the cervical region have paralysis of both the upper and
lower extremities with effects on body organs such as the
lungs. "'he;are called quadriplegics. However, often the
term wparaplegic' is used as a general description of a per-
son suffering an SCI, regardless of the level of injury.

     The main determinant in recovery of function after an
SCI is the level of the injury to the spinal cord. Injuries



                               4
in the cervical region usually result in quadriplegia
with paralysis of both arms and legs and with involvement
of bladder and bowel functions. The higher levels, 'those
above the fourth cervical level, are usually fatal.
     Persons with injuries at the sixth and seventh cervical
level have nearly normal shoulder and elbow function, but
diminished hand function. These persons are often able to
perform many elements of self care, but are significantly
dependent on others. Patients with injuries at the eighth
cervical and first thoracic levels have most of their hand
functions, but despite paralyzed lower limbs, bowels and
bladder can achieve nearly complete independence. Persons
with injuries at the second thoracic level and below are
parapalegic with normal upper extremity function but para-
lyzed legs. Their bladder, bowel and sexual functions are
also affected. These individuals are capable of complete
independence but are confined to a wheelchair. Not until
the level of injury is in the mid-lumbar segments is
reasonable ambulatory function possible with the help of
crutches and foot braces.
     The medical complications and functional disabilities of
SCI are more serious than might be apparent. Paralysis of
the legs does more than prevent walking. It can cause severe
and painful muscle contractions, spasticity, and orthopedic
deformities. The sensation of pain is lost in the affected
area, thus removing a body safety mechanism. Pain signals
danger from heat, cold, and pressure. These signals reach
healthy persons even while they are sleeping, causing phys-
ical reactions. Thus, we change our sleeping position with-
out waking because of the discomfort of skin and body tissues
which have been under pressure. We shift our position when
awake, too, often without realizing it. Lacking sensation in
large areas of his body, both asleep and awake, the para-
plegic develops decubitus ulcers (pressure sores) on his
buttocks, heels, and other bony parts of his body. A
paraplegic's ability to perspire is also impaired. Since
perspriation helps to cool the body under conditions of
severe heat, the SCI victim is vulnerable to hot weather and
to fever caused by mild infections due to his reduced ability
to perspire.

    Paraplegics may also lose voluntary control of their
bowel and bladder functions. Genital sensation may be lost
and sexual function impaired. Urinary infections, bladder
stones. end gastrointestinal disorders are frequent compli-
cations. Bladder catheterization is usually needed, either
continuously or on an intermittent basis and catheterization
itself can be a cause of infection. Respiratory disorders


                              5
are also a serious complication and problem for quadriple-
gics.
     Along with the physical disabilities and complications,
an SCI victim and his family must cope with emotional prob-
lems. The victim may suddenly be dependent on others, of-
ten at a tome of life when he is at a peak of physical and
social independence. Career, financial independence,
marriage, family, and social relationships are all changed.
Although rehabilitation and a somewhat satisfactory life
style are now possible, the patient's own psychological
adjustment to his disability is zriti:al to his recovery.
      According to NIH and VA officials, most spinal cord
injuries are thoue of contusion (bruising), crushing or
destruction due to loss of blood flow. If the sprinal cord
is compared to a telephone cable containing thousands of
wires, damage to the cord is similar to twisting and
 Dissolving of the individual wires with a resultarnt gap
in the cable and a barrier composed of non-conducting
material introduced at the location of the damage. In a
minority of cases, the cord is transected (cut) at the time
of injury and all function is immediately lost.

     NIH and VA officials told us that while paralysis is
immediate after a traumatic SCI, the pathological processes
that result in destruction and death of nerve tissue evolve
over a tour to six hour period. SCI research showed that
during this period circt ition is impaired and hemorrhage
begins in the central gray matter of the cord. Oxygen
levels in the nerve tissues drop and the hemorrhage
continues to spread causing cell death. Following this,
edema (swelling) forms in the spinal white matter and
causes degeneration of the spinal nerve fibers. This
degeneration produces an actual gap in the spinal cord
nerves. Scar tissue forms at the point of the damage
and motor and sensory functions are lost. The process
then spreads up and down the spinal cord sometimes
involving destruction of brain cells. These officials
told us that in order to prevent permanent injury to the
spinal cord, this process must be stopped very early
in its progression.
     Present day SCI research is mainly directed in two
areas. The first area of research is called spinal cord
injury research and its goal is to limit the degeneration
in the spinal cord by preventing the sequence of events
that occurs after an injury. The second field of research
is directed towards stimulating or encouraging the orderly
regrowth of spinal nerve fibers. Such research is called
regeneration research. To date, no one has been akle to
regenerate nerves in the human spinal cord. Proqress and
problems in spinal cord injury and regeneration research
will be discussed in Chapter 5.
                           CHAPTER 2
                     EXTENT AND CAUSES OF
                      fMAL- RDC INJURIES
INCIDENCE AND PREVALENCE

     Numerous studies have been performed on the extent
of spinal cord injuries in the United States with vast
differences in their results.

     In a study released in 1975, NIH estimated that
there were 100,000 victims of traumatic spinal cord injury
and nearly 10,000 new cases each year.

     In 1974, the National Paraplegia Foundation (NPF),
an organization providing primarily information and
referral services for paraplegic on matters such as
rehabilitation, care, and research, also studied spinal
cord injury. NPF estimated that in 1970 there were 46,700
victims of traumatic spinal cord injury alive in the United
States and that this figure will increase to 75,2000 by
1980. NPF estimated that 3,190 new cases occurred in 1974.
     Also, in 1974, the Rehabilitation Services Admini-
stration (RSA) estimated that the total number of SCI
victims to be between 100,000 and 125,000. RSA said
that 7,000 to 10,000 new cases occur each year.

     Studies have shown that young people suffer most
from SCI. In 1976, NPF stated that 90 percent of the
victims are between the ages of 16 and 30, and a 1974
study by RSA yielded similar results.
CAUSES

     We identified seven studies that assessed the causes
of SCI. While four of the studies were conducted outside
of the United States and were conducted during different
time periods (1968-1976) all the studies showed motor
vehicle accidents to be the leading causes of SCI. For
example, using the results of a 1974 California study,
NIH said that motor vehicle accidents account for 56
percent of all acute SCI cases. The table below
summarizes the results of the three American studies.
                                  Causes of SCI (in percent)
                       Motor Vehicle Falls     Sports Assault Other

NIH (1974)                   56           19      7     12     6

Rancho Los Amigos SCI
  Center, Calif. (1969)      48           12     lla/   19     10

Florida Study (1976)         38           16     21     18     7

a/Diving only
                          CHAPTER 3
                          METHODS OF
                  TREATING SPINAL CORD INJURY
     At the time of World War I only 10 percent of paraple-
gics lived for a year after injury according to NIH. Today,
90 percent survive and after one year following the injury
their mortality rate only slightly exceeds that of the gen-
eral population. These results are attributable to a number
of factors which are discussed below.
DIAGNOSTIC ADVANCES

     Once an SCI victim's condition is stabilized, a thorough
neurological examination with specific attention to demon-
strating the presence or absence of function in the spinal
cord below the injury is the main part of diagnosis, accord-
ing to medical officials we interviewed. A new development
in testing the ability of the spinal cord to function is
through "evoked sensory corti, al potentials." This technique
involves placing recording electrodes on the patient's scalp
and stimulating peripheral nerves below the injury. The elec-
trodes pick up any responses and a recorder prints out the
results. The primary value of this technique is in distin-
guishing complete from incomplete injuries.
     Another diagnostic advance has come in the development
of myelography which is a special technique to photograph the
spinal cord. Myelography involves injecting a substance into
the area around the spinal cord (called th- aQinal canal) to
enhance X-rays taken of the cord and its soft tissue.

TREATMENT OF INJURY RELATED PROBLEMS
     Several clinical advances have been made in treating
acute SCI related problems. Injury below the waist often
results in loss of bladder and bowel function. Thus, bladder
and bowel infections are a problem and urinary tract compli-
cations are a major cause of death for paraplegics.  The
development of antibiotics, the specialty of urology and
educating the patient in proper bladder and bowel maintenance
have greatly aided in solving these problems.

      A major advance in preventing urinary infections is the
development of the technique of intermittent catheterization
to pass urine.   A catheter, which is a tubular instrument




                             10
used for withdrawing body fluids, is inserted into the
bladder through the urethra every six to eight hours.
Urine is then withdrawn through the catheter, emptying the
bladder. Before the development of this technique, a
catheter had to be inserted permanently in the victim.
According to the medical officials we interviewed, the
catheter itself was often a cause of infection. Medical
studies by hospitals using intermittent catheteriztion have
shown that 75 to 85 percent of patients were free from
urinary infections upon discharge.
     Advances in treating bowel problems have consisted
mainly of establishing a regular elimination pattern for the
patient through a combination of proper diet, massage and
rectal stimulation.

     Decubitus ulcers (pressure sores) are a serious problem
for paraplegics. When a paraplegic remains in the same
position for an extended period, the constant pressure of
the body's weight will cause the skin to break down and
sores to develop. Because of paralysis, the SCI victim can
neither perform the shiftings and turnings that are natural
to healthy people, nor feel that a sore is developing.
Today, this problem can be virtually eliminated, according
to medical authorities.
     Prevention of pressure sores is based on maintaining
good general skin condition and avoidance of prolonged skin
pressure. To accomplish the latter, special'y designed beds
have been developed so that the patient can be turned to
relieve pressure while confined to bed and special wheel-
chairs have been developed to prevent pressure on the
patient's skin. In addition, the victim is educated on the
necessity of avoiding prolonged skin pressure and the impor-
tance of daily inspections of the parts of the body most
susceptible to pressure sores.
     When a person suffers an acute SCI, the muscles below
the injury often are still function but cannot be cont-
trolled. This condition is called spasticity. Severe spas-
ticity is treated by either muscle relaxants or surgery.
According to a neurosurgeon at the University of Maryland
Medical School, surgery to reduce spasticity has an initial
success rate of 90 percent, but only about 50 percent of
patients having such surgery retain any long term benefit.
One of the biggest problems for quadriplegics is muscle
calcification (hardening of tissue resulting from calcium
deposits), according to a physician at the Institute for
 Rehabilitation Medicine in New York. When muscle
                                                   calcifi-
 cation occurs, motion becomes impossible. These problems
 have been lessened through improved rehabilitation tech-
 niques and returning the patient to activity in a short
 period of time.

     All quadriplegics suffer impairment
function to some degree because the chest of respiratory
                                           and abdominal
muscles are paralyzed. Injuries above the fourth
                                                   cervical
level result in total paralysis of the diaphram and
                                                     life
is not possible without artificial respiratory support
within minutes after injury.

TREATMENT OF SPINAL CORD INJURY

     According to medical authorities, an SCI is usually
caused by an external force on the spine. The force causes
the spine to come into contact with the spinal cord and
results in damage to the cord. While specific methods
treating damage to the spine causing injuries to the    of
                                                     spinal
cord have been developed, there art no accepted methods
practice for treating damage to the spinal cord itself. in

     Treatment used on the individL4l patient will vary
the level of injury and the amount of damage to the cord.with
In those injuries involving complete transection of the
all that is done is to heal the associated injuries      cord,
                                                     as effec-
tively as possible and prevent the complications
paralysis. However, most SCI's are incomplete andwhich  follow
                                                    the spe-
cific modes of treating incomple SCI are discussed below.

     Skull traction
     Skull traction is used to correct
dislocation and immobilize the spine. spinal  deformity and/or
                                       Several mechanical
devices have been designed to provide the traction.
     As practiced at the VA Acute Spinal Cord Injury Center
in West Roxbury, Massachusetts, skull traction is performed
after diagnostic X-rays have been taken. The alignment
the traction is adjusted in accordance with the X-rays. of
Assuming reduction in the deformity or dislocation is
achieved with skull traction, the procedure is
one to eight weeks, depending on the level and continued for
                                               extent of the
injury. X-rays are taken to determine that healing
occurred before the traction is removed.            has




                             12
     Spinal fusion
     According to VA medical authorities, the primary indica-
tions for a spinal fusion operation are the failure of spon-
taneous healing with abnormal spinal mobility or increasing
spine deformity. Fusion is also used with other surgical
procedures. The level of the injury and the amount of damage
will determine whether the operation is to be performed and
if so, the type of operation.
     Neurosurgeons at New York University Medical Center and
Bellevue Hospital Acute Spinal Cord Injury Center stated
that they normally use the fusion operation to realign the
vertebrae of the spine. Misaligned vertebrae cause pressure
on the spinal cord and increase damage. During the opera-
tion, the damaged vertebrae is removed and a piece of bone,
taken from the patient's hip, is inserted into the area where
the damaged vertebrae was removed. Once this has been accom-
plished, specially designed steel support rods are inserted
into the spine to add stability and to keep the proper align-
ment. Large doses of steroids are used to reduce swelling.

     Laminectomy
     A laminectomy is performed to relieve pressure on the
spinal cord. It is an operation whereby the bony protective
shields along the spine, the laminae, are removed and the
vertebrae are realigned and stabilized. Officials at New
York University Medical Center, Bellevue Hospital Acute SCI
Center, and NIH said that laminectomy may produce increased
mobility of the spine. Such mobility, however, may increase
contusions and bruises of the spinal cord and could lead to
increased neurological damage.
     According to VA neurosurgeons, only if diagnostic
studies show material pressing on the spinal cord from the
spine which correlates with the neurological damage should
the laminectomy be performed.  Such an approach is shared
by NIH authorities. In their opinion, the only reason to
perform a laminectomy is to expose the spinal cord for other
surgical procedures.

ACUTE SPINAL CORD INJURY CENTERS
     Some medical authorities told us that the quality of
spinal cord injury treatment in the United States is
heavily dependent upon the experience and expertise of the



                              13
personnel treating such an injury. These officials. said
that due to the low incidence rates of SCI, it is unlikely
that the average hospital will have experienced people
trained in dealing with SCI and cognizant of the importance
of proper treatment during the first few hours following
injury.  In order to rectify this situatic :, some medical
officials said that a concept for treating acute SCI devel-
oped in England and now accepted generally in Europe should
be more widely used in the United States. This concept
involves establishing acute spinal cord injury centers
throughout the country. These centers were described by
the medical officials as a significant advance in treating
acute SCI.
     The acute spinal cord injury center concept was devel-
oped by Dr. Ludwig Guttman, a British neurosurgeon at the
Stoke-Mandeville Hospital in England. Guttman's concept
begins with early case finding and referrals. It also con-
sists of having highly trained emergency medical service
personnel, organized in comprehensive regional systems and
provided with proper equipment, communications, vehicles,
and easily accessible medical facilities. Once the patient
arrives at a center he is treated by a clearly defined team
of physicians, surgeons, specially trained nurses, and other
professionals ranging from physical therapists to vocational
rehabilitation counselors. The patient not only receives
services from all these disciplines, directed and coordi-
nated by a single physician in charge of his case, but he
receives these services concurrently. From acute care
through rehabilitation he is followed by the same team.
Rehabilitation services such as physical therapy, psycholog-
ical counseling, and vocational planning begin as soon as
acute medical and surgical procedures are accomplished. The
patient is followed steadily by the physicians involved at
the acute stage, as well as by specialists such as urologists
and orthopedic surgeons.
     Some medical officials we interviewed stated that
employing the acute SCI center concept does not require a
substantial construction program. On the contrary, they
said the center should be a part of an existing hospital
(preferably a hospital connected or affiliated with a
teaching facility, such as a university) with a full com-
plement of medical surgical services.
     Medical officials said a spinal cord unit should range
from a minimum of 20-30 beds to a maximum of 50-60 beds.
Units smaller than 20 beds are unable to ensure a patient



                              14
turnover rate sufficient to retain an incentive program for
the staff. Also. the financial burden on the hospital
would be unbearab.e. Units over 60 beds become unwieldy
and difficult to manage effectively, according to medical
authorities.
     One person with sufficient training and experience
should direct the spinal cord unit, according to medical
officials. This individual should have total responsibility
for all aspects of patient care. Because of the numerous
problems involved in spinal cord injury cases, a large, well-
trained staffwith varied and specialized medical and surgi-
cal knowledge and special equipment is required.
     Close cooperation among the various specialties--general
surgery, plastic surgery, orthopedics, neurosurgery,
neuorology, urology, internal medicine, psychology, psychia-
try, social medicine, physical medicine, vocational counseling
and placement, dietetics, and others, is required for success
in treatment, according to medical authorities. Since no
single specialist in his own field can be expected to master
the totality of knowledge required, it is necessary for the
chief of the spinal cord injury center to be trained in a
multi-disciplirary approach which will allow him to be know-
ledgeable most areas and to properly evaluate each situatior.
Ideally, any chief of the spinal cord injury center should be
capable of leading a team of specialists who, because of their
own speciality, cannot have a general overview of all the
problems involved with a given patient.

     According to NPF, Dr. Guttmann's concept has been very
effective in returning many patients to functional independ-
ence. According to medical officials we interviewed, the
acute SCI center concept provides the best possible medical
care for a patient. However, medical officials stated very
few patients suffering acute SCI in the United States are
treated at these centers. Medical officials told us the
reasons for this are because there are too few acute SCI
centers in the United States and the general public and
the medical profession are not aware of this treatment
concept. We attempted to develop a comprehensive listing
of the facilities in this country having acute SCI centers,
but were unable to do so. None of the Federal agencies
nor organizations we contacted has this information. Bowever,
the facilities listed below are ones we identified in our
review as having acute SCI centers.




                              15
     In addition to the facility at Bellvue Hospital, 1/ we
found that NIH currently supports research at acute:spinal
cord injury research centers located at Ohio State University;
Yale University; St. Joseph's Hospital and Medical Center,
Phoenix, Arizona; the Medical University of South Carolina,
New York University; and Albany Medical College. However,
NIH funds provided to these centers are for recearch on
spinal cord injuries and regeneration, not for clinical care
or rehabilitation of patients. In September 1977, NIH
initiated a new program on a pilot basis to evalute the
efficacy of therapy to the spinal and head injured patient.
This program of Comprehensive Central Nervous Trauma Centers
includes six contracts totaling $625,000 in fiscal year 1977.
     The Veterans Administration has 18 facilities designated
as spinal cord injury centers. However, VA officials told us
that only four of their facilities (West Roxbury,
Massachusetts; Palo Alto, California; Wood, Wisconsin; and
Tampa, Florida) are capable of treating acute SCI. The rest
provide primarily long-term nursing care. Further, VA
officials told us that the only facility actually treating
acute SCI is the one at West Roxbury.




1/ Bellvue Hospital Acute SCI Center is not funded by NIH.



                               16
                          CHAPTER 4

               COSTS OF SPINAL CORD INJURIES

     We identified three recent studies by private
organizations that assessed the costs of spinal cord injuries.
The Paralyzed Veterans of America (responsible for represent-
ing veterans' claims before the Veterans Administration)
issued a study in 1973, the National Paraplegia Foundation
issued a study in 1974, and the Insurance Institute for High-
way Safety (attempts to identify and reduce losses resulting
from motor vehicle accidents) issued a study in 1976. 1/ NIH
is studying the costs of SCI, but its report was not completed
in time to be considered in our study. The NIH study was
the only one we could find that was being done by the Federal
Government on the costs of spinal cord injury.
     We utilized the above studies to provide estimates of
the cost of SCI.
     The studies showed vast differences in the estimated
costs of SCI. These differences are due to a variety of
factors:
     -- there are no accurate figures on the incidence or
        prevalence of spinal cord injuries, so total costs
        are difficult to estimate,

     -- costs per individual vary with level of injury, age
        and sex; and the studies approached these matters
        differently,

     -- costs were not projected for a uniform period of time
        in all the studies,

     -- the same cost categories were not included in each
        study, and

     -- the Paralyzed Veterans of America study used 1973 as
        a base year for estimated costs while 1974 was used
        for the National Paraplegia Foundation and the In-
        surance Institute for Highway Safety studies.



l/The study performed by the Insurance Institute for Highway
  Safety dealt only with the costs of spinal cord injuries
  resulting from motor vehicle accidents.   We are reporting
  its findings because motor vehicle accidents have been
  shown to be the major cause of spinal cord injuries.

                              17
     For the reasons cited, we found it very di ficult to
assess the accuracy or reliability of the figures contained
in the studies.
COST COMPONENTS
     The cost studies we reviewed identified the following
cost components of acute spinal cord injuries:
     Direct Costs
     Emergency Assistance
     Hospitalization
     Physician Fees
     SCI Center Staff Costs
     SCI Center Capital Costs
     Medical Equipment and Home Modifications
     Vocational Rehabilitation
     Miscellaneous Supplies and Services
     Nursing and Attendant Care
     Other Medical and Drug Costs
     Rehospitalization

     Indirect Costs
     Lost Earnings
     Psychic Costs
     Insurance Administration Costs
     Legal and Court Costs

     The di ct costs of a disease or injury are the expendi-
tures associated with the treatment of that disease or injury.
According to IIHS, spinal cord injuries are characterized Dy
high initial hospitalization costs and significant health
related maintenance charges that accrue over the lifetime of
the patient. Collectively, these costs constitute the direct
costs of the injury.
     Indirect costs are defined as the lost output or produc-
tivity of the victim during his disablement. Indirect costs
represent an economic loss to society as well as a persona]
economic loss to the SCI victim and his dependents. While the
NPF and IIHS included indire:t costs in their estimates, both
such costs. The PVA did not estimate indirect costs of SCI.
     We identified the various components of SCI indirect
costs. Of the four components which are listed above, both
the NPF and IIHS agreed that lost earnings--the value of an


                             18
SCI victim's expected future earnings lost because of injury--
is the largest contributor to indirect costs. However, the
studies differed in how lost earnings should be determined.

     A discussion of the various di-   t cost components
associated with SCT follows. The     :   which appears on
page 25 summarizes the total lifet,    iirect costs of SCI
as reported in the studies. We did not attempt to
estimate indirect costs because such estimates are highly
speculative.

DIRECT COSTS

     Emergency Assistance
     Prior to hospital admission, SCI patients may incur
emergency assistance costs. These include the costs of:
police and fire assistance; emergency transportation to the
hospital, and emergency medical treatment upon arrival at
the hospital. IIHS estimated these costs would total $400.
NPF and PVA did not report this as a separate cost item.

     Initial Hospitalization
     According to NPF, hospitalization costs include hotel
services, nursing, ancillary services (operating room,
laboratory work) and general overhead costs. All three
studies estimated hospital costs per SCI patient by multi-
plying the average hospital expense per patient day times the
average length of stay of SCI patients.

     While all three studies agreed on how initial hospitali-
zation costs should be determined, the studies differed
greatly in the estimates of these costs. These differences
are due to the range in the length of hospital stay used for
an SCI patient, and differences in costs included as a part
of hospitalization.

     PVA estimated that the average length of hospital stay
for an acute SCI patient to be 120 days and the total hospi-
talization costs to be $18,000. NPF estimated the average
length of stay to be 182 days and hospitalization costs to
total about $32,8000. IIHS estimated the average length of
stay to be between 104 and 235 days (depending on the extent
of the injury) and total hospitalization costs to be between
$15,600 and $38,540.




                               19
     Phys-cian Fees
     During initial hospitalization, there would be fees for
the attending physician, neurosurgeon, and other consultants,
according to NPF. NPF estimated these fees to total $1,800
and PVA estimated them to be $1,500. IIHS did not report
physician fees as a separate cost item, but included these
costs as a part of initial hospitalization expenses.

     SCI Center Staff Costs

     In addition to the staff of physicians, nurses, and
other personnel whose services are provided in a general
hospital, patients at an acute SCI center are treated by a
team of medical and health professionals in many Aisciplines.
NPF reported these costs as a separate item in their study,
while IIHS and PVA did not. NPF estimated these costs would
total $8,200 per patient. These costs would not usually be
incurred if the patient is treated at a general hospital.

     SCI Center Capital Costs
     In addition to estimating SCI center staff costs, NPF
stated that the cost of building and equipping an SCI center
must be apportioned to the patient. These costs would not be
incurred if the patient was treated at a general hospital.
NPF estimated these costs at $1,400 per patient. The other
two studies did not identify capital costs separately.

     Medical Equipment and Home Modification Costs
     Because of the loss of voluntary motor function in their
extremities, SCI patients need prosthetic equipment, medical
appliances, and certain modifications to their homes in
order to function. Such items as wheelchairs, leg braces,
and hospital beds are needed in order to perform activities
of daily living. In- addition, narrow doorways and small
bathrooms may require modification in order for the SCI
victim to function in his home. Kitchen appliances may
have to be adjusted, the bed may have to be lowered to make
wheelchair transfers, and closet rods and doors may have to
be adjusted to facilit te dressing. Further, lowering
doorknobs, light switc¢.es, and telephones, plus raising
electric outlets may be necessary to aid activity throughout
the home. The type, number, and thus the costs of 7edical
equipment and home modifications vary according to ,,,e
patient's level of injury, with quadriplegics usually incur-
ring more costs than paraplegics, according to IIHS.


                              20
     IIHS estimated average home modification costs to be
$2,850 for a paraplegic and $6,400 for a quadriplegic.  In
addition, IIHS estimated average annual equipment costs
(includes amortized purchase costs and expected repair
costs) to be $210 for a paraplegic and $420 for a quadriple-
gic with no estimates of the total expected lifetime costs.

     PVA estimated home modification costs to be $4,000
or $8,000 depending on injury level and initial
equipment costs were estimated at $500 or $1,000. PVA
estimated annual equipment replacement and maintenance costs
at $300 with no estimates of total lifetime costs.
NPF grouped equipment and home modification costs together.
NPF estimated these costs to initially total $4,900 but
did not estimate annual or lifetime costs.
    Vocational Rehabilitation
     According to NPF and IIHS, most SCI victims need to
reassess their vocational status and to modify their future
career plans. To do this, SCI victims need some type of
vocational rehabilitation. IIHS estimated that 48 percent
of quadriplegics and 63 percent of paraplegics undergo
vocational rehabilitation and that this training begins
anywhere from three to 18 months after the patient is
discharged from the hospital.
     IIHS estimated vocational rehabilitation costs at
$2,180 for a paraplegic and $3,540 for a quadriplegic.
NPF estimated these costs at $5,000 with no distinction
for level of injury. PVA did not report vocational costs
separately.
     Miscellaneous Supplies and Services
     According to IIIS, spinal cord injury victims incur
costs for miscellaneous supplies and services. Costs
in this category include unusual or special expenses
for transportation, laundry, bedding, clothing, and non-
medical appliances such as electric typewriters and air
conditioners.

     In the case of transportation, SCI patients who can
drive require the installation of hand controls in their
automobiles. Those patients who are either unable or un-
motivated to drive may require taxi and chauffeur services
and quadriplegics may require a specially outfitted van
equipped to allow easy passenger entrance and exit.


                            21
     Uncontrolled bowel and bladder problems and the long
periods of time an SCI patient may have to spend in bed
all contribute to increases in laundry and bedding expenses.
      IIHS estimated the annual costs of these miscellaneous
supplies and services at $490 for a paraplegic and $530
for a quadriplegic. The only comparable item that PVA
reported in this category was transportation costs which it
estimated at $1,000 for a paraplegic and $2,000 for a quadri-
plegic. NPF did not report these costs separately, but
included some in other categories.
     Nursing and Attendant Care
      Following discharge from the hospital, some SCI patients
require continuing assistance, according to IIHS. While
paraplegics can manage with minimal assistance, quadriplegics
may need assistance in eating, dressing, changing bed posi-
tion, transferring from bed to wheelchair, and performing
other bodily functions. The manner in which this assistance
is rendered is related to the extent of injury of the victim.
An SCI victim may be placed in a nursing home or chronic care
hospital, receive attendant care at home, or require virtually
no assistance. IIHS reported that 16 percent of quadriplegics
and 6 percent of paraplegics receive permanent institutional
care. NPF reported that approximately 75 percent of SCI
victims live at home with attendant care. According to NPF,
the main difference resulting from treatment in an acute SCI
center as opposed to a general hospital is the functional
level regained by the victim. NPF stated that the majority
of non-SCI center treated patients require some form of
nursing care for the rest of their lives whether it is pro-
vided by an institution or family. In contrast, the majority
of SCI center patients become functionally independent and
employable, according to NPF.
      IIHS estimated the annual costs of nursing and attendant
care to range from $790 to $1,000 for a paraplegic and
$2,840 to $7,730 for a quadriplegic.   IIHS gave no estimates
of the lifetime costs of nursing and attendant care.
     Using a complex formula, NPF stated that nursing costs
per year amounted to $7,500 for an SCI victim. Adjusting
for dependency and injury levels and years of life expectancy,
NPF estimated the average total lifetime costs of nursing and
attendant care to be $25,600 or $59,700 dejending on whether
the victim received initial treatment in an acute spinal cord
injury center or general hospital. PVA did not provide esti-
mates of these costs.
    Other Medical and Drug Costs
     Regardless of their functional status, SCI patients are
vulnerable to disease and complications from their injury.
The majority of medical and drug costs, according to IIHS,
are determined by the extent of bowel and bladder impairment.
Further, quadriplegics suffering paralysis in the upper part
of their bodies run the risk of pneumonia and other pulmonary
ailments. All of these problems translate into an increased
demand for medical supplies and drugs.
     IIHS estimated annual medical and drug costs to be $800
for paraplegics and $1,200 for quadriplegics. IIHS gave no
estimate of the lifetime costs under this category.
     NPF also reported costs under this category, but in-
cluded rehospitalization and treatment expenses in their
calculations. NPF reported medical costs at $1,500 per annum
and $17,100 for a patient's lifetime.
     PVA estimated annual medical and drug costs at $700 with
no estimate of total lifetime expenses.
     Rehospitalization
     According to IIHS, even after an SCI victim has been
discharged from the hospital and rehabilitated, there is the
possibility of rehospitalization. Rehospitalization may
be required for the previously mentioned complications that
could result from SCI.
    IIHS reported that very little data exists on the fre-
quency of rehospitalization of SCI patients and thus it is
difficult to project rehospitalization costs. However, from
the little data that was available and judgmental assessments
of medical and cost experts in the spinal cord field, IIHS
stated that annual rehospitalization ranges from two to 15
days per patient with an annual cost ranging between $300 and
$2,460. PVA reported annual rehospitalization costs of
$2,100. NPF did not provide a separate estimate of
rehospitalization costs but included these costs as a part
of medical and drug costs.



                             23
     Lifetime Direct Costs of SCI
     All three studies estimated the total lifetime'direct
costs for a victim of SCI with vast differences in results.
The following table displays the figures included in each
study.




                            24
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                                 CHAPTER 5
          PROGRESS AND PROBLEMS IN SPINAL CORD INJURY
                  AND REGENERATION R-ESEARCH


     Regeneration of the spinal cord is an attempt to regrow
nerve fibers to restore body motor function and sensation.
Until recently it was accepted medical theory that the spinal
cord was incapable of regeneration. According to medical
researchers at NIH, recent research has shown that the spinal
cord may be capable of regeneration. According to medical
authorities, however, the following problems need to be solved
before regeneration can be accomplished:

     -- nerve cells must survive both the immediate trauma
        of SCI and the destructive changes that occur after
        the injury,
     -- nerve cells must initiate and sustain growth along
        the nerve tracts,
     -- nerve fibers must be able to cross abnormal terrain
        such as the dense scar tissue which forms at the
        site of the injury creating a nearly impenetrable
        wall which causes the few fibers that could be induced
        to cross the scar to be choked off and killed, and
     -- the nerve fiber must establish "functional recognition"
        whereby it meets the correct target and establishes
        proper function--electrical attraction, chemical
        attraction, or a combination of the two have been
        suggested as the guidance mechanism.
Research on the spinal cord has been primarily directed at
solving these problems and, as a result, has evolved into
spinal cord injury and regeneration research.

PROJECTS FUNDED ON SPINAL CORD
INJURY AND REGENERATION RESEARCH
     We identified three organizations currently supporting
research in the area of spinal cord regeneration and spinal




                             26
 cord injury. 1/ The National Institute for Neurological
 Communicative Disorders and Stroke (NINCDS) oversees        and
 research at NIH and provides most of the funds        such
                                                 for government
 supported research in these areas. VA is the only
                                                     other gov-
 ernment agency, and the Paralyzed Veterans of America
 only private organization we found supporting research is the
 these areas. NINCDS was supporting both intramural       in
 mural research at the time of our review. VA was     and  extra-
 only intramural projects and PVA was supporting    supporting
                                                  only extramural
 projects. We obtained data on the number of research
                                                        projects
 and related funding amounts for the three agencies.
                                                       To make
 the figures more meaningful we categorized the projects
 as follows:
        -- spinal cord regeneration research--research directly
           related to spinal cord regneration;
        -- spinal injury research--research aimed at preventing
           the progressive post-injury nrrve fiber degeneration,
           and
       -- related research projects relevant to spinal cord
          research but having less of a direct application
          to the areas of regeneration and spinal injury.
     The following table shows a total of 100 projects
supported in the amount of about $6.5 million.
projects funded by NINCDS and VA are for fiscal The research
                                                 year 1976.
PVA's data is cumulative for fiscal years 1972
                                                through 1976.




1/   In addition to the agencies listed above, our review
                                                           showed
     that several other Federal agencies have either
                                                      supported
     spinal cord injury and regeneration
     or have dealt with aspects related toresearch in the past
                                            SCI such as elec-
     tronic prosthesis and stimulation research or peripheral
     nerve regeneration. This matter will be discussed
     subsequent part of this study. See pages 41 to      in a
                                                      42
     discussion of the other agencies dealing with these for  a
                                                          areas.



                               27
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                                                                    28
     Grant applications recommended
     forapproval but unfunded
     According to NIH officials, the following projects were
approved as having scientific merit but unfunded due to a
lack of funds during the period June 1975 to September 1976.

                                      Projects     Amount
     Spinal cord regneration             3       $ 72,489
     Spinal injury research            13         520,609
     Research related to spinal
       injury and regeneration          4         172,139
          Total                        20        $765,237
     VA and PVA did not have projects awaiting funding because
they initiate proposals for research. Proposals for NIH
extramural research usually are not initiated in-house.

     Increased funding
      An NINCDS official and other medical authorities said
that a sudden upsurge of funding would not guarantee rapid
advances in spinal cord injury and regeneration. The NINCDS
official emphasized that solving spinal cord injury and
regeneration research problems is not only a matter of
increased research funds, but of equal importance is training
researchers in the field of spinal cord injury and regenera-
tion.   He told us that not many facilities nor researchers are
presently available that can undertake this type of research,
and NINCDS has no designated training program for spinal cord
injury and regeneration. He estimated that an additional
$5.5 million could be beneficially used in the spinal cord
injury and regeneration area in fiscal year 1978. Of the
additional $5.5 million increase in funds, $500,000 could be
used by NINCDS to begin a training program and $5 million could
be used to award targeted research grants.

SPINAL CORD INJURY RESEARCH
     Spinal cord injury research is aimed at prevention of
the progressive degeneration of the spinal cord after injury.
In theory, if the structure of the nerve tracts can be pre-
served then function will not be lost. According to medical
authorities, this research is based on the following factors:



                               29
     -- The spinal cord, in most patients, is not cut
        initially but merely bruised or contused. Shortly
        after injury the cord is still structurally intact;
     -- Hemorrage and swelling in the cord over a period of
        hours after injury will lead to progressive degenera-
        tion of the nerve fibers;

     -- Complete degeneration will result in actual structural
        discontinuities (gaps) in the nerve fibers connect in
        the spinal cord;
     -- The degenerative mechanisms that are thought to occur
        following injury are not well understood;

     -- Regeneration and restoration of functions will be
        easier to accomplish if the degenerative processes
        are stopped as soon as possible because there will be
        fewer structures to restore.

     Medical authorities stated that the possibility of
successful treatment of SCI has been enhanced by the discovery
that irreversible paralysis does not occur at the time of
injury (unless the cord is severed) and that the best possi-
bility for recovering from SCI occurs when the victim is
properly treated within 4 to 6 hours after injury. In an
experimental setting, the components of the complex biochemical
reaction leading to nerve fiber degeneration have been modified
by a variety of physical and pharmacological means resulting
in a lessening of the destruction and some degree of preserva-
tion or return of function.

     Physical attempts used to prevent degeneration include
hyperbaric oxygen, cooling of the cord, and myelotomy (incision
of the spiral cord). Hyperbaric (high pressure) oxygen is
infused into the tissues of the cord to increase its oxygen
concentration, based on the theory that decreased blood flow
in the cord starves it of oxygen. Lack of oxygen may cause
degeneration of nerve tissue. Cooling of the cord is accom-
plished by an operative procedure which exposes the spinal
cord. It is then irrigated with a saline solution in an
effort to slow the cord metabolism and prevent swelling.
Myelotomy has been attempted, on a trial basis, at the
Bellevue Hospital Acute Spinal Cord Injury Center, in an
attempt to provide internal decompression of the cord. An
incision directly into the cord theoretically will release
the pressure caused by swelling. In order to perform a
myelotomy, a laminectomy must first be performed to expose
the cord. The cord is then incised and the fluids causing


                             30
tissue death are released. This technique is new and its
benefit in treating SCI is not established.
     Pharmacological (drug) cherapy used in an attempt to
prevent cord degeneration includes steroids and chemical
agents to lessen bleeding and prevent clotting. Drug therapy
is based in part on the hypothesis that drugs (including
alcohol) have been proven to enhance the post-injury degen-
erative processes, according to NIH officials. Therefore,
drugs may be beneficial in reversing this process. Steroids
have been used in the clinical setting in increasing doses
to prevent swelling. Surgeons at Bellevue Hospital Acute
SCI Center have recently increased the amounts of steroids
used on spinal cord injury victims because lower doses com-
monly in use had inconclusive results. Chemical agents to
lessen bleeding have been used to try to lessen hemorrhage
by slowing blood flow. Similarly, hormones have been used
to decrease the possible traumatic effects of other chemicals
produced by the body as a result of the spinal cord injury.
Neither approach has shown positive results.
     With the exception of limited success in the use of
myelotomy and steroids, demonstration of the beneficial
results in the leboratory have not been translated into
successful clinical treatment of spinal cord injury. Medical
authorities stated that the reasons for discrepancies in
laboratory results and clinical application may be due to the
experimental model being used which is an exposed animal's
spinal cord, subjected to injury and treated almost immediate-
ly. In most actual injuries involving humans, the cord is not
exposed because it is encased in the body cavity and protected
by the spine. In addition, there is usually a delay between
the time of injury and treatment in humans. Medical authori-
ties also said that the discrepancies may be due to differences
between human and nonhuman spinal cords.

REGENERAATION RESEARCH
INTHE UNITED TATES
     In 1973 the Director of the NINCDS appointed an ad hoc
subcommittee on growth and regeneration in the central nervous
system of the NINCDS national advisory council. This subcom-
mittee was charged with reviewing and evaluating the status
of research on regeneration and to identify areas of research
where opportunities for advances existed.
     A series of scientific workshops was sponsored by the
subcommittee in which scientists from all over the country
participated. Subsequently the subcommittee prepared a report


                             31
 in 1975 which summarized the results of
 meetings and made recommendations to the the scientific
                                           council ins three
 general categories: (1) high priority research
 training, and (3) planning and coordination.    areas, (2)

     The high priority research areas evolved from
which showed that abortive central                  research
                                   nervous system regenera-
tion occurred in mammals but that function
                                            is almost never
recovered except in simpler creatures. The
stated that investigation of the biological subcommittee
such regenerative growth may in time result ryles governing
effective rege eration in mammals, even in in functionally
committee concluded that the following areashumans. The sub-
                                              of research
had the best chance for success.
Axonal and dendritic      longation
     This research is aimed at studying the behavior
growing axon (nerve fiber) and the agents that       of the
outgrowth.                                     facilitate

Collateral sprouting

      After an axon is severed and the portion at
the injury degenerates, axons from intact          the level of
sideways and reestablish functioning nerve nerve  cells grow
have shown that some axons of the central   fibers.   Studies
                                           nervous system are
capable of collateral sprouting and growth
                                            following tran-
section. The significance of collateral sprouting
to the recovery of function remains questionable. as related
tors at Ohio State University Medical School         Investiga-
                                              considered col-
lateral sprouting to be useless for recovery
                                              of function.
Intraaxonal   transport
      Research has shown that the
protein and that the protein can cell  body synthesizes
                                  be rapidly transported down
the length of the axon to the point of the
                                            trauma. The pro-
tein is used for transmitting nerve impulses
axonal growth. Protein is also transmitted and for sustained
endings back to the cell nucleus. Discovery from the cell
                                              of a dual system
of axonal transport is a new development and
that two-way communication exists within the it established
c:entral nervous system.                      nerves of the




                                32
Properties of neurons with
damaged axons --
     This research involves studying the responses of nerve
cells to nerve fiber damage and is important because such
damage may cause the death of the cells.
Synaptogenesis
     Two cells must make a specific functional contact in
order to be effective. The question of how cells recognize
their appropriate partners and the mechanisms for recogn -^ n
that allow for specificity of contacts is vital for the
eventual restoration of function.

Biology of neuroglia
     Glial cells, collectively known as neuroglia, support
cells in the central nervous system, but their biochemical
function is unknown. However, researchers do know that
without the glial cells the nerve cells die. Neuroglia are
deemed important because a type of these cells, the Schwann
cell, is present in the peripheral nervous system but is not
present in the central nervous system. Researchers speculate
that these cells may be the reason the peripheral nervous
system can regenerate and the central nervous system cannot.
     In addition, when the spinal cord is damaged, the scar
tissue that is formed is composed of glial cells. Conse-
quently, further knowledge of the biological processes of
these cells may aid in promoting regenerative growth.
Development of biological systems
     In relation to the problem of spinal cord regeneration,
new biological systems are needed to study the effects of SCI
and for cultivating nerve cells. Presently the model for
causing traumacic spinal cord injury in an animal is exposure
of the cord by a surgical procedure followed by the drop of
a weight directly on the exposed cord. However, this is not
the way spinal cord injury usually occurs. Some researchers
are dissatisfied with this method and are attempting to
develop a method for causing traumatic spinal cord injury on
a closed system.
     A second area in which new systems are required is in the
area of cell growth. NIH researchers stated that the medium in
which nerve cells are grown may have an effect on the growth.
In order to insure scientific accuracy of results, the medium
must have no effect on the experiment.


                             33
 Drug hormone effects
     Research is currently underway to discover drugs or
hormones which will promote nerve growth and regeneration
the central nervous system. Particular attention has been in
paid to the protein Nerve Growth Factor. While this protein
has had some success in promoting growth of peripheral nerves,
the subcommittee reported that its early promise has dimmed
and its effects on the central nervous system are inconclusive.
     In addition to these eight high priority areas, NINCDS
is continuing its program of basic research in the area
the biochemical processes occuring in the central nervousof
system.
     One example of NINCDS supported basic research is work
presently underway at Johns Hopkins University Medical School
in neuro-embryology. Using a baby chick as the experimental
animal, the spinal cord is cut at a point in time prior to
the development of its glial cells. The research showed that
the nerve fibers will regenerate through the area
because no glial scar tissue forms to block their of the clt
                                                  growth.
     A second example is work underway at Cornell University
Medical School using a goldfish as the experimental model.
Prior research established that the goldfish optic nerve
will regenerate when cut. Research is now directed towards
determining the cell processes occuring before, during, and
after the nerve is cut.
Nerve implant technique
     A very promising regeneration project, according to NIH
official>, is research supported by the VA called the delayed
nerve implant technique. Using the dog as the experimental
animal, the spinal cord is crushed with forceps. Tests are
then conducted to insure that no nerve impulses were contin-
uing to be transmitted through the spinal cord. After wait-
ing for a period of 1 week for the cord to degenerate, periph-
eral nerves are transplanted into the gap in the damaged
spinal cord. The implanted nerve serves as a conduit or
bridge along which the nerve fibers may grown.
     Examinations of the treated spinal cords several
after the operation established that the nerve fibers weeks
fact regenerated. Of 10 dogs treated, 4 were able to had  in
                                                      stand
and 2 could also walk. In addition, all the dogs retained
some bowel and bladder function.



                             34
      NIH officials explained that the delayed implant
 is a scientific advance. Previous nerve implants hMd technique
                                                        been
done immediagely after injury. The ensuing nerve degenera-
 tion created a gap in the cord around the implant and
 regeneration unsuccessful. Delaying the implant for made
                                                       1
 allows the degenerative process to stop. The peripheralweek
nerve tissue can then be attached to each tip of the
on either side of the gap in the spinal cord and will axon
                                                        pro-
vide a bridge completely across the gap in the cord.
officials suggested that a 1 week delay in performing NIH
                                                        the
technique means that scar tissue has probably not formed.
As a result, a barrier to nerve regeneration is removed.
      There is some scientific difference of opinion as to
whether these regenerated nerve fibers enabled the dogs
                                                          to
walk again or whether the dogs were demonstrating 'reflex
walking." The apparent walking movements are controlled
the spinal cord and do not involve neural transmissions by
originating in the brain. Researchers at NIH and the
                                                       Univer-
sity of Maryland Medical School consider the dog to be
choice of an experimental model because of its ability a poor
perform 'reflex walking."                                to

     According to an NIH scientist, additional research using
monkeys as the experimental animal is in the planning
                                                       stage
at NIH.  If success is achieved with primates, preliminary
experiments are also being planned using paraplegics
minor impairments.                                    with

      Another problem with this technique is that to
 implanted nerves have been taken either from another date  the
                                                       leg of
 the test animal or from the legs of animals in the same
as the test animal. This is done to prevent rejection litter
 implant. However, the removal of the sciatic nerve      of the
used for the implant) leaves the leg paralyzed. The   (the  nerve
cability of this technique to man is still in doubt,   appli.
to NIH officials. One possibility is to implant nerves according
                                                           from
deceased persons. However, little is known about the
bility of rejection or other immunological responses    possi-
human body to an implant from a genetically different of the
                                                        person.
REGENERATION RESEARCH IN
THE SOVIET UNION
     Much attention has been given to advances in regeneration
by scientists in the Soviet Union. In order to evaluate
regenearation research done by the Soviets, we discussed
                                                         their
techniques and experiments with NIH officials and independent



                              35
medical authorities and reviewed literature published in the
Soviet Union. The following discussion summarizes the opin-
ions of the medical authorities we interviewed on the
Soviet research.

     In 1973 two scientists, Dr. L.A. Matinian and A.S.
Andresian, Orbeli Institute of Physiology, Yerevan, USSR,
published a paper entitled 'Enzyme Therapy in Organic Lesions
of the Spinal Cord" in which they described their experiments
with enzymes to inhibit scar formation at the point of damage
to the cord of female white rats. They claimed that they
could make these rats walk again. In May and June 1976,
NINCDS sponsored two meetings to which three Soviet scien-
tists, including Dr. Matinian, were invited to make presen-
tations on their clinical and experimental treatment of spinal
cord injury, including enzyme therapy.
     Dr. Matinian made a presentation on enzyme research,
including a film depicting the results of his work. Enzyme
therapy was used on female white rats that were subjected to
SCI. In various combinations, four types of enzymes were
used--trypsin, elastase, pyrogen, and hyaluronidase.
Dr. Matinian and his associates decided to use enzymes to
attempt to create favorable conditions for nerve fiber growth
in the severed spinal cord by inhibiting scar formation and
by promoting regeneration of neurons in the spinal cord.
     The female white rats used were 6 to 7 weeks old, of
which 348 were subjected to various types of enzyme therapy
and 110 were untreated control animals. During the course
of the experiment, the cord was exposed and transected. The
wound was flushed with scline solution, followed by an admin-
istration of enzynme preparation. Various combinations of
the enzymes were administered by either flushing into the
wound at the time of the operation or by intramuscular
injection. Control animals were given the saline solution
only. All animals received constant post-operative care.
     Evaluation of the effectiveness of the enzyme therapy
was measured by comparing responses to stimulation in treated
and untreated animals; measuring the amount of electrophysio-
logical stimulation that reached hind limb muscles by brain
stimulation and by comparing the experimental and control
animals anotomically and with tissue slides. The results
of the experiments according to the Soviet studies showed:
     -- Treated rats lived longer and had less infections
        than untreated rats.



                             36
     -- Function was restored in a high percentage of the
        enzyme-treated rats, ranging from a low of 33 per-
        cent of those rats treated with hyaluronidase alone
        to 80 percent of those received trypsin to 92.5 per-
        cent of those animals receiving combination therapy.
        Functional restoration included the return of bladder
        and motor functions and spontaneous coordinated
        movements.
     -- Brain stimulation in the treated animals showed that
        nerve impulses were transmitted across the site of
        the transection. This was interpreted to mean that
        the nerve fibers had bridged the gap between the cut
        ends of the spinal cord in the enzyme-treated rats
        and had made the proper functional connections with
        neurons above and below the transection.

     -- Tissue slide studies established that the treated
        rats had a reduction in scar tissue and showed nerve
        fibers crossing the areas of the transection.
     -- Regeneration and functional restoration in enzyme-
        treated rats were maintained throughout their life-
        time.
     --The treated rats had a very high mortality rate
       unless constantly attended during the post-operative
       period.

       Thus the Soviets claimed to have solved both the
problems of functional recognition and regeneration. Regarding
the treatment of human subjects in the Soviet Union,
Dr. Matinian and his neurosurgical colleagues stated that
enzyme therapy has been used clinically but the results are
inconclusive.

     Evaluation of the Soviet research
     NINCDS officials who attended the meetings with the
Soviets were dubious about the significance of their
research. According to these officials, the film showing
the results of enzyme therapy was very confusing in that it
was difficult to know which animals were experimental and
which were controls. The officials said that tissue slide
sections presented were of poor quality, the histological
techniques used were of the pre-World War II variety and
chemical tissue analysis was lacking.




                             37
        In their experiments,
  two percent of female white NIH researchers have found that
                                rats which suffer complete spinal
  cord transection will recover
                                  and be able
  treatment.   As a result, NINCDS officials to walk without any
  the interpretation to                         were skeptical
  showing the rats that be  drawn from Dr. Matinian's film of
                         recovered from SCI after enzyme
                                                             therapy.
       Further criticism was voiced
  the normal scientific progression by NIH officials in that
                                      of using enzymes on larger,
 more highly developed animals
                                  in the experiments had not been
 done. However, the Soviet experiments
 rats was considered to be worthy           with enzyme-treated
 officials. In order to evaluate     of further   study by NINCDS
                                     this  research,  the experi-
 ments must be independently duplicated
 analyzed using modern technology           and the  results
                                     and methodology. NINCDS
 has awarded a contract to a researcher
 Maryland Medical School to duplicate       at the University of
 Preliminary results of this              the Soviet experiments.
                               research
 contentions of the Soviet scientists    have  not supported the
 of the spinal cord.                     regarding   regeneration

 PROSPECTS FOR A BREAKTHROUGH
 IN SPINAL CORD REGENERATION
       Experts in the field of
 of a significant, short-term regeneration agreed that chances
                                breakthrough are remote. Much
 basic scientific research remains
 two main problems in regenerationi, to be done. Neither of the
                                        regrowing the spinal nerve
 tracts and providing functional
The Soviet enzyme experiments,      recognition have been solved.
offer hope for the solution of if independently verified,
nerve implant technique requires  both problems. The delayed
                                     additional work but it has
shown nerve regeneration is
mising approach in the field, possible    and is currently a pro-
                                 according to medical authorities.
      Medical authorities said that
                                       the best approach at the
present time for solving the
from acute SCI is to increase  problem   of paraplegia resulting
injury centers in the "'nited   the   number  of acute spinal cord
                               States while encouraging research
to continue on early treatment
                                  and regeneration.
COMPUTER BY-PASS APPROACH

      In addition to research on spinal
regeneration, research has been          cord injuries and
passing the injured spinal cord  undertaken  that involves by-
searchers are attempting to use  by electronic  means. Re-
                                 signals
spinal cord, brain, and peripheral        generated in the
directly to either the peripheral   nerves and apply them
                                   nerves or the spinal cord



                              38
below the area of the injury. Simultaneous feedback is
required wherein sensory nerves feed information through
the central nervous system to the brain.

     Researchers at the University of Texas Medical School
said that in order to successfully achieve a by-pass of an
injured spinal cord, signals must be acquired and recorded
through electrodes implanted in the nervous system when the
brain sends a message to the body through the spinal cord.
Signals so acquired must be processed and interpreted by a
micro-computer and then reintroduced back into the body in
a format that is comprehensible to the body. Basic control
mechanisms operating within the nervous system must be mapped
and understood in order to provide sensory feedback from the
peripheral nervous system through the spinal cord to the brain.
None of these areas is without difficulty, according to Uni-
versity of Texas researchers.

     The implanted electrode used to acquire signals consti-
tutes a foreign body and generally produces a tissue reaction
such as an infection or an immunological response from the
body's disease defense system. If implanted directly into the
cord, the electrode may become corroded by the spinal fluids.

     Signals are acquired from the nervous system in continuous
fashion in large numbers. At any one time a vast number of
nerve impulses are being transmitted through the nervous
system. When a specific movement is desired, a signal is
sent down the spinal cord and becomes part of the multitude
of other signals carried by the nerve fibers in the cord.
The spinal cord acts as a filter which separates the signals
and translates them into the desired movement. Researchers
at the University of Texas and Rancho Los Amigos Hospital
said that at the present state of the art, scientists can
neither filter out unwanted signals to isolate the desired
signals, nor can they reintroduce the signals back into the
nervous system in a language the body can understand.
Electronic signals, after processing in a micro-computer,
and reintroduced into the nervous sytem, have been so altered
that the body does not respond. Researchers at NIH, VA, and
the University of Michigan considered the computer by-pass
approach to be beyond the level of our present technology.

     Ongoing research with a better chance of success,
according to medical researchers at Case Western Reserve
University, involves an attempt to bypass the central nervous
system injury by recording, amplifying, processing, and stim-
ulating at the level of the peripheral nerves. Signals in a


                           39
healthy portion of the peripheral nervous system are applied
directly to either a muscle or a peripheral nerve below the
level of the spinal cord injury in an attempt to provide
stimulation and restoration of function.




                            40
                          CHAPTER 6
                  TRAINING AND COORDINATION
     The NINCDS National Advisory Council ad hoc
Subcommittee on Growth and Regeneration in the Central
Nervous System made recommendations to NINCDS in the areas
of training and coordination which the Institute has not
implemented due either to a shortage of funds or to concern
with the appropriateness of the recommendation.
TRAINING

      In the field of training, the subcommittee recommended
that more emphasis, facilities, and personnel should be
directed towards the training of scientists for careers
in spinal cord regeneration. An NINCDS official stated
that the Institute agreed with this recommendation, but,
as previously discussed on page 29, NINCDS has no train-
ing program in spinal cord regeneration due to a lack of
funds.    The $500,000 suggested by an NINCDS official to
begin a program could be used to train ten to fifteen
post-doctoral trainees a year. This level of funding
would provide a reasonable number of spinal cord regeneration
specialists, according to the NINCDS official.
     To continue progress in the field of spinal cord
regeneration, according to medical authoritites, will
require investigators to be trained in an institution which
affords both clinical and research opportunities. This
broad experience would enable researchers to spend their time
and effort on problems which, when solved, will lead to
improvement in the condition of the spinal cord injured.
Acute spinal cord injury centers were suggested by
academic researchers and practicing clinicians as the
milieu most likely to provide such experience.

COORDINATION EFFORTS
      Our review showed that several agencies of the Federal
government are involved with the broad problem of spinal
cord injury and regeneration with no central direction and
each group pursuing its own course in the field. NIH and
VA both support research in spinal cord injury, regeneration
and electronic prosthesis.   The Rehabilitation Service.
Administration and the National Aeronautics and Space
Administration support electrical stimulation research in
dealing with spinal cord injury.




                            41
       The Department of the Navy
  on peripheral nerve regeneration.is supporting nine.projects
                                     In fiscal year 1977, these
 projects cost about $374,000. The
 tion is supporting one project on National Science Founda-
                                     peripheral nerve regenera-
 tion. In fiscal year 1977 the project
 In addition, the Department of the        cost about $35,000.
 injury and regeneration research fromArmy  supported spinal cord
 through 1975 at a total cost of about    fiscal year 1973
 work showed that no structured format    $1.1 milllion.   Our
 the efforts of the various parties       exists for coordinating
                                      involved. Medical auth-
 orities at the Federal level said
 results from personal relationships that  coordination of efforts
                                       among the concerned
 parties, membership in peer review
 professional meetings.               groups and attendance at

     Regarding the issue of coordinating
the field of spinal cord injury and        research efforts in
                                     regeneration,
subcommittee made three recommendations.              the
recommended that a standing advisory        It  first
nervous system growth and regenerationcommittee on central
to monitor research and make policy      be established
NINCDS. An NINCDS official stated    recommendations    to
                                    that
was inappropriate because there already   this recommendation
advisory group that performs the functionsexists an
by the subcommittee. As a result,            recommended
                                   NINCDS has not acted on
this recommendation.
      The subcommittee recommended that
national lay groups with interests       NINCDS encourage
                                    in particular
diseases to recognize a common objective          neurological
on the central nervous system. An         in promoting  research
                                   NINCDS
that the Institute participate? with       official told  us
                                      national lay organ-
izations when invited, but the Institute
                                          believes it would
be inappropriate for the Federal government
to control lay agencies research             to attempt
                                 efforts.
      The final recommendation made by the
that NINCDS should  coordinate the exchange subcommittee stated
                                             of ideas among
researchers. An NINCDS official told
choice must be made as to              us that often times a
                           whether the Institute should
sponsor a conference to exchange ideas
                                        and coordinate
research efforts or to continue awarding
proposals. NINCDS planned to sponsor       meritorious research
                                       an
in the spring of 1976 where coordination symposium
efforts and the status of SCI and          of research
                                   regeneration research
were to be discussed but the Institute
due to a lack of funds.                 was forced to cancel it




                             42