Improving Hand Recovery With Neuromodulation in Tetraplegia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Spinal Cord Injuries
- Sponsor
- Sara Shahid Salles
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Change in Spinal Cord Independence Measure
- Status
- Terminated
- Last Updated
- 4 years ago
Overview
Brief Summary
This study will examine a form of non-invasive brain stimulation applied with intensive therapy of the arm and hand. The goal of the study is to determine if arm and hand function can be improved in people with incomplete cervical spinal cord injury (neck spinal cord injury, tetraplegia). Participants will be assigned to receive either active or inactive non-invasive brain stimulation.
Detailed Description
This study will look at the effects of a painless, non-invasive form of brain stimulation, called transcranial direct current stimulation, or tDCS. tDCS is thought to increase the brain's ability to change. Participants will be assigned to one of two groups by chance. One group will receive tDCS at a level expected to increase the brain's ability to change, while the other group will receive tDCS at a level not thought to affect the brain's ability to change. All participants will receive intensive therapy of their more impaired arm and hand, focusing on exercises that are meaningful to him/her.
Investigators
Sara Shahid Salles
Professor
University of Kentucky
Eligibility Criteria
Inclusion Criteria
- •traumatic, incomplete cervical SCI sustained at neurological level C4-C7 and classified as B, C or D by the American Spinal Injury Association Impairment Scale (AIS);
- •sustained injury at least 1 year prior to enrollment (i.e., chronic); and
- •Men and women between the ages of 18-65.
Exclusion Criteria
- •history of head injury, seizures, severe alcohol or drug abuse, or psychiatric illness;
- •cognitive deficits severe enough to preclude informed consent;
- •positive pregnancy test or being of childbearing age and not using appropriate contraception;
- •presence of ferromagnetic material in the cranium except in the mouth, including metal fragments from occupational exposure and surgical clips in or near the brain;
- •decubitus ulcers that might interfere with intervention;
- •cardiac or neural pacemakers;
- •fixed UE contractures;
- •untreated depression;
- •concurrent participation in occupational therapy;
- •within 3 months of recruitment, an addition or change in the dosage of drugs known to exert detrimental effects on motor recovery.
Outcomes
Primary Outcomes
Change in Spinal Cord Independence Measure
Time Frame: Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up
This evaluates self-care, respiration and sphincter management, and mobility.
Secondary Outcomes
- Change in Graded and Redefined Assessment of Strength, Sensibility, and Prehension(Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up)
- Change in Van Lieshout Test(Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up)
- Semi-structured interview about study(Immediately post-intervention, 4-month follow-up)
- Change in Canadian Occupational Performance Measure(Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up)
- Change in Medical Research Council Scale Upper Extremity Manual Muscle Test(Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up)
- Change in cortical motor map volume(Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up)