Improving Motor Function After Spinal Cord Injury



Status:Recruiting
Conditions:Hospital, Orthopedic
Therapuetic Areas:Orthopedics / Podiatry, Other
Healthy:No
Age Range:18 - 85
Updated:11/17/2018
Start Date:February 11, 2016
End Date:February 1, 2021
Contact:Kiara C Melendez
Email:kcm26@med.miami.edu

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Enhancement of Hand Motor Function After Cervical Spinal Cord Injury

The goals of this study are to examine the physiology of Central Nervous System pathways
contributing to the control of upper and lower extremity movements after SCI, and to promote
the recovery of extremity movements by using non-invasive brain stimulation and motor
training.

This study will consist of electromyography (surface and intramuscular), peripheral nerve
stimulation, and transcranial magnetic stimulation, electrical stimulation, of the hand, arm,
leg, and foot representation of the primary motor cortex, as well as MRI scans of the brain.
The investigators will examine the physiological measurements of upper and lower extremity
muscles (such as in the first dorsal interosseous (FDI), biceps brachii (BIC), anterior
deltoid (AD), tibialis anterior (TA), hamstring (HAMS) and quadriceps (QUAD)). This study may
occur at the Miami Project to cure Paralysis at the University of Miami. The investigators
will include subjects between the ages of 18 and 85, both healthy controls and individuals
with chronic spinal cord injuries that occurred at least 6 months prior to recruitment. Both
healthy controls and those with spinal cord injuries will be able to perform small hand and
arm movements and small leg and foot movements. The primary outcome measures of this study
are muscle responses to stimulation with magnetic pulses using TMS and electrical stimulation
of a peripheral nerve in the arm or leg. The investigators propose to enhance the recovery of
motor function by using new protocols of high frequency non-invasive repetitive TMS (rTMS)
and motor training. Repetitive TMS will be used during hand, arm, leg and foot movements in a
task-dependent manner to induce cortical plasticity and enhance voluntary output of the
muscles associated with those movements. Second, rTMS will be applied in a task-dependent
manner during a visuo-motor training task that also involves movements of the hands, arms,
legs or feet.

Inclusion Criteria:

Male and female Veterans and non Veterans with spinal cord injury at least 6 months after
injury was sustained. The investigators also plan to enroll control subjects who do not
have any history of spinal cord injury.

Participants who are unimpaired healthy controls:

- Male and females between ages 18-85 years

- Right handed

- Able to complete precision grips with both hands

- Able to complete full wrist flexion-extension bilaterally

- Able to walk unassisted

- Able to complete full ankle flexion-extension bilaterally

Participants who have had a spinal cord injury:

- Male and females between ages 18-85 years

- Chronic SCI ( 6 months of injury)

- Spinal Cord injury at or above L5

- The ability to produce a visible precision grip force with one hand

- Individuals who have the ability to pick up a small object (large paperclip) from a
table independently

- Able to perform some small wrist flexion and extension (measured by a goniometer)

- The ability to perform a small visible contraction with dorsiflexor and hip flexor
muscles

- No subjects will be excluded based on their race, religion, ethnicity, gender or HIV
status.

Exclusion Criteria:

Exclusion criteria for enrollment For SCI and Healthy Control Subjects (for stimulation):

- Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic
disease

- Any debilitating disease prior to the SCI that caused exercise intolerance

- Premorbid, ongoing major depression or psychosis, altered cognitive status

- History of head injury or stroke

- Metal plate in skull

- History of seizures

- Receiving drugs acting primarily on the central nervous system, which lower the
seizure threshold (see appendix 2)

- Pregnant females

- Ongoing cord compression or a syrinx in the spinal cord or who suffer from a spinal
cord disease such as spinal stenosis, spina bifida, MS, or herniated cervical disk

- Individuals with scalp shrapnel, cochlear implants, or aneurysm clips.
We found this trial at
3
sites
Miami, Florida 33125
Principal Investigator: Monica Alicia Perez, PhD
Phone: (305) 575-7000
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4100 Allequippa Street
Pittsburg, Florida 15240
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