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| Name | Class |
|---|---|
| Wings for Life | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active tDCS | Experimental | 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. |
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| Sham tDCS | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcranial direct current stimulation | Device | This is a non-invasive form of stimulation which delivers safe, low levels of electrical current to the brain through the scalp. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Spinal Cord Independence Measure | This evaluates self-care, respiration and sphincter management, and mobility. | Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sara Salles, MD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky at Cardinal Hill Rehabilitation Hospital | Lexington | Kentucky | 40504 | United States |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D011782 | Quadriplegia |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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| Intensive upper extremity motor training | Behavioral | This training is administered one-on-one with an occupational therapist. Activities will be focused on skills the participant wants to regain. |
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| 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. | 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. | 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. | 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. | 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. | 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. | Immediately post-intervention, 4-month follow-up |
| D014947 | Wounds and Injuries |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |