An interventional study of transcranial direct current stimulation and Intensive upper extremity motor training in Spinal Cord Injuries and Tetraplegia, Unspecified, Incomplete, Chronic, sponsored by Sara Shahid Salles. Terminated at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-06-24.
Sponsored by Sara Shahid Salles · Not applicable, Interventional, and Treatment
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.
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.
1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.
This study's enrollment of 6 is below the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →This is the only study on the registry with Sara Shahid Salles as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: transcranial direct current stimulation · Behavioral: 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.
Device: transcranial direct current stimulation · Behavioral: Intensive upper extremity motor training
This is a non-invasive form of stimulation which delivers safe, low levels of electrical current to the brain through the scalp.
This training is administered one-on-one with an occupational therapist. Activities will be focused on skills the participant wants to regain.
Change in Spinal Cord Independence Measure
This evaluates self-care, respiration and sphincter management, and mobility.
Time frame: 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
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.
Time frame: Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up
Change in Canadian Occupational Performance Measure
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.
Time frame: Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up
Change in Graded and Redefined Assessment of Strength, Sensibility, and Prehension
This measures strength, sensibility, and prehension to obtain information about motor and sensory function.
Time frame: Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up
Change in Van Lieshout Test
This test evaluates upper extremity motor performance in cervical spinal cord injury.
Time frame: Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up
Change in cortical motor map volume
This is performed using non-invasive transcranial magnetic stimulation to determine which parts of the brain control a muscle in the arm or hand.
Time frame: Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up
Semi-structured interview about study
Participants will be asked about motivations and goals for the study.
Time frame: Baseline
Semi-structured interview about study
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.
Time frame: Immediately post-intervention, 4-month follow-up
Plan to share: No
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This study is terminated, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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