III. NIH Human Clinical Trials
As of 2/15/96

I. Project Number: 5 M01 RR00058-34 SUB: 0331

Principal Investigator:

MAIMAN, DENNIS
MEDICAL COLLEGE OF WISCONSIN
8701 WATERTOWN PLANK ROAD
MILWAUKEE, WI 53226

Performing Organization: MEDICAL COLLEGE OF WISCONSIN

Amount: $10,716 per year

Title: GENERAL CLINICAL RESEARCH CENTER SUB TITLE EFFICACY & SAFETY
OF SYGEN VS PLACEBO TREATMENT IN ACUTE SPINAL CORD INJURY

Grant Expires in : 1 Fiscal Year(s)

Abstract:

The objective of this study is to determine the efficacy and safety of two doses of Sygen in the
treatment of patients with acute SPINAL CORD injury.

Keywords:

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drug adverse effect
drug screening /evaluation
spinal cord injury
nervous disorder chemotherapy
human therapy evaluation
clinical trial
acute disease
dosage
human subject
placebo

II. Project Number: 5 P01 NS16333-15 SUB: 0010

Principal Investigator:

DOBKIN, BRUCE
UNIVERSITY OF CALIFORNIA
405 HILGARD AVE
LOS ANGELES, CA 9

Performing Organization: UNIVERSITY OF CALIFORNIA LOS ANGELES

Amount: $175,456 per year

Title: NEUROMUSCULAR PLASTICITY--RECOVERY AFTER SPINALIZATION SUB
TITLE REHABILITATION TO ENHANCE STEPPING IN PEOPLE WITH CHRONIC
SPINAL CORD INJURY

Grant Expires in : 1 Fiscal Year(s)

Abstract:

No specific rehabilitative strategy has been shown to enhance lower extremity motor function and
improve locomotion after a SPINAL CORD injury (SCI) in man. Experiments on adult cats
after thoracic SPINAL CORD transection show that the lumbosacral CORD isolated from
supraspinal input can activate rhythmic stepping while the hindlimbs are fully weight supporting. In
addition, this locomotor ability is strongly influenced by the type of motor training that the animal
receives. Preliminary studies from two laboratories raise the possibility that paraplegic patients
can be trained to generate a stepping pattern. In the 4-year randomized, prospective, controlled
clinical trial, we will study the motor output from subjects with chronic thoracic SCI. A stepping
motor output will be elicited using a partially assisted body weight support along with rhythmic
oscillation of the lower extremities. Stepping will be facilitated by treadmill training that is similar
to the procedure which has been used in the Program Project's studies with spinally transected
cats.

We will define the locomotor characteristics, as well as measures related to functional recovery
and quality of life, that arise from this rehabilitative therapy. Evidence of extensor and flexor
muscle activation and the timing of these activities during treadmill stepping will be determined
from electromyographic (EMG) recordings in patients who range from complete sensorimotor
loss below their SCI (graded Frankel A) to less severe impairments in subjects who retain some
supraspinal descending influences on the lumbosacral segments and may be able to execute
locomotion (graded Frankel B, C and D). About 26 SCI time from onset of injury, and residual
strength (Motor Index Score). The study will include at least 3 matched pairs for each Frankel
grade. One of the two subjects of each pair will be randomly assigned to body weight support
and treadmill (BWS & T) training and will begin a 3-month course. When that subject completes
the course, the second subject of each pair will begin. All subjects will initiate their training at 18
m/min with the minimum amount of weight support assistance necessary for them to step. Training
will continue at that speed until they achieve an effective gait at full weight bearing, at which time
they will advance to the next higher treadmill velocity. This training will be repeated until the
maximum speed is achieved. We will evaluate effectiveness of the this intervention with repeated
measures of a combination of physiological and biomechanical data obtained as subjects step on
the treadmill and, if capable, walk overground, as well as by physiological and morphologic
analysis of muscle function. These studies will also provide insight into some of the physiological
actions of antispasticity medications, which will be used where appropriate after a subject's
maximal treadmill velocity is achieved. We propose to use a highly stratified design with controls
to provide scientific validity and statistical efficiency.

Keywords:

You may use the keywords to find similar grants. The right hand button selects the
indicated keyword while the left hand button allows you to combine different keywords
together with the boolean "and".

rehabilitation
spinal cord injury
chordate locomotion
human therapy evaluation
biomechanics
clinical trial
cyproheptadine
clonidine
antispasmodic agent
nervous disorder chemotherapy
paraplegia
neuromuscular system
sensorimotor system
neuropharmacology
neural plasticity
limb movement
quality of life
gait
human subject