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Trial record 15 of 299 for:    Recruiting, Not yet recruiting, Available Studies | "Spinal Cord Injuries"

Improving Motor Function After Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT01915095
Recruitment Status : Recruiting
First Posted : August 2, 2013
Last Update Posted : December 27, 2017
University of Miami
Information provided by (Responsible Party):
VA Office of Research and Development

July 19, 2013
August 2, 2013
December 27, 2017
February 11, 2016
January 1, 2020   (Final data collection date for primary outcome measure)
changes in amplitude of motor evoked potential [ Time Frame: post treatment at minute 0, minute 10, minute 30, minute 60 ]
at stated minute intervals assessments will be made to see the effect
The primary outcome measures of this study are muscle responses evoked by using transcranial magnetic stimulation of the primary motor cortex and electrical stimulation of a peripheral nerve in the arm [ Time Frame: Within the first 90 days after the study intervention ]
Complete list of historical versions of study NCT01915095 on ClinicalTrials.gov Archive Site
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Improving Motor Function After Spinal Cord Injury
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.
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Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Spinal Cord Injury
  • Device: rTMS
    small magnetic pulses will be given to the brain in a non invasive manner.
  • Device: Sham rTMS
    sham or fake stimulation (TMS or rTMS) will be given to the brain in a non invasive manner
  • Other: Training
    at the direction of the researcher the participant will be instructed to do repetitive motor movements with their arm, hand or leg. this is called training
  • Other: Motor Task
    participants will be asked to perform specific motor tasks or movements with their fingers, hands, arms or legs.
  • Active Comparator: Motor task+ Magnetic stimulation
    Participants will be asked to complete a precision grip with the index and thumb finger at the same time as flexing or extending the wrist. magnetic stimulation to the brain will be administered and measurements will be taken during movement.
    • Device: rTMS
    • Device: Sham rTMS
    • Other: Motor Task
  • Active Comparator: rTMS/sham rTMS
    Participant will be randomly assigned to one of 3 groups: repetitive transcranial magnetic stimulation (rTMS), sham (fake) rTMS, or sham (fake) rTMS over control brain area will be administered to the brain. the stimulation will be targeting finger and wrist muscles during movement.
    • Device: rTMS
    • Device: Sham rTMS
  • Active Comparator: Training + rTMS/ Sham rTMS
    Participants will be asked to follow a target line on the computer as accurately as possible while performing precision grips or foot movement . Magnetic stimulation will be given during rest and movement.
    • Device: rTMS
    • Device: Sham rTMS
    • Other: Training
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
February 1, 2021
January 1, 2020   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
Contact: Francisco D Benavides, MD (305) 575-7000 ext 3179 franciscodavid.benavidesjaramillo@va.gov
Contact: Monica A Perez, PhD (412) 383-6563 perezmo@miami.edu
United States
20151113 ( Other Identifier: University of Miami )
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Plan to Share IPD: Undecided
VA Office of Research and Development
VA Office of Research and Development
University of Miami
Principal Investigator: Monica Alicia Perez, PhD Miami VA Healthcare System, Miami, FL
VA Office of Research and Development
December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP