Improving Hand Recovery With Neuromodulation in Tetraplegia
- Conditions
- Tetraplegia, Unspecified, Incomplete, ChronicSpinal Cord Injuries
- Interventions
- Device: transcranial direct current stimulationBehavioral: Intensive upper extremity motor training
- Registration Number
- NCT03954496
- Lead Sponsor
- Sara Shahid Salles
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 6
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active tDCS transcranial direct current stimulation Subjects will receive 20 minutes of active transcranial direct current stimulation at 2.5mA, followed by 2 hours of intensive motor therapy of the more affected upper extremity. Active tDCS Intensive upper extremity motor training Subjects will receive 20 minutes of active transcranial direct current stimulation at 2.5mA, followed by 2 hours of intensive motor therapy of the more affected upper extremity. Sham tDCS Intensive upper extremity motor training Subjects will receive 20 minutes of sham transcranial direct current stimulation, followed by 2 hours of intensive motor therapy of the more affected upper extremity. Sham tDCS transcranial direct current stimulation Subjects will receive 20 minutes of sham transcranial direct current stimulation, followed by 2 hours of intensive motor therapy of the more affected upper extremity.
- Primary Outcome Measures
Name Time Method Change in Spinal Cord Independence Measure 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 Outcome Measures
Name Time Method 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 This measures strength, sensibility, and prehension to obtain information about motor and sensory function.
Change in Van Lieshout Test Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up This test evaluates upper extremity motor performance in cervical spinal cord injury.
Semi-structured interview about study Immediately post-intervention, 4-month follow-up Participants will be asked about their experience in the study, whether they experienced any changes in function during the study, and whether they have recommendations for change.
Change in Canadian Occupational Performance Measure Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up The participant selects 5 tasks they would like to be able to perform, and score their performance as well as satisfaction with their performance of the tasks.
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 This evaluates the strength of various muscles in the upper extremity. Each muscle that is tested can be scored from a minimum of 0, indicating no strength, up to a maximum of 5, indicating normal strength. Scores are assigned to each side by summing the scores from each of the 41 individual muscles, with a minimum possible total score of 0 and a maximum possible total score of 205. Higher values indicate greater strength.
Change in cortical motor map volume Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up This is performed using non-invasive transcranial magnetic stimulation to determine which parts of the brain control a muscle in the arm or hand.
Trial Locations
- Locations (1)
University of Kentucky at Cardinal Hill Rehabilitation Hospital
🇺🇸Lexington, Kentucky, United States