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| Name | Class |
|---|---|
| University of Minnesota | OTHER |
| Teachers College, Columbia University | OTHER |
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The goal of this study is to test the efficacy of transcranial direct current stimulation combined with bimanual training on hand function in children with unilateral spastic cerebral palsy (USCP). Children who enroll in the protocol will be randomized to receive either sham (not stimulating) tDCS plus bimanual training, or active (stimulating) tDCS plus bimanual training.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active tDCS + bimanual training | Experimental | In this arm, participants will engage in 120 min of bimanual training. Bimanual training involves using both hands to play with toys and games during the study. During the first 20 min of bimanual training, participants will receive active tDCS via sponges over the scalp. |
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| Sham tDCS + bimanual training | Experimental | In this arm, participants will engage in 120 min of bimanual training. Bimanual training involves using both hands to play with toys and games during the study. During the first 20 min of bimanual training, participants will wear the tDCS device that is worn by the active tDCS group, but in the sham group, participants will not receive stimulation during this 20 min period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| active transcranial direct current stimulation | Device | Participants will receive 20 min of tDCS over the scalp during the first 20 min of bimanual training. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Assisting Hand Assessment | Measure of how well the child uses both hands cooperatively for bimanual activities | Day before intervention begins, compared to day after intervention ends (six days after intervention begins) |
| Measure | Description | Time Frame |
|---|---|---|
| Jebsen-Taylor Test of Hand Function | Measure of movement speed of affected hand | Day before intervention begins, compared to day after intervention ends (six days after intervention begins) |
| Box and Blocks test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kathleen M Friel, PhD | Contact | 914-368-3116 | kaf3001@med.cornell.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kathleen M Friel, PhD | Burke Medical Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Burke Medical Research Institute | Recruiting | White Plains | New York | 10605 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35190424 | Background | Gordon AM, Ferre CL, Robert MT, Chin K, Brandao M, Friel KM. HABIT+tDCS: a study protocol of a randomised controlled trial (RCT) investigating the synergistic efficacy of hand-arm bimanual intensive therapy (HABIT) plus targeted non-invasive brain stimulation to improve upper extremity function in school-age children with unilateral cerebral palsy. BMJ Open. 2022 Feb 21;12(2):e052409. doi: 10.1136/bmjopen-2021-052409. |
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The investigators will share IPD via the NIH Data Hub (DASH), which is sponsored by NICHD.
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Data will be available when study is complete, and remain in DASH indefinitely.
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Children will be randomly allocated to one of two parallel arms of the study.
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Participants and care providers will not be told of their group allocation. Participants in the sham group will receive a brief stimulation of the scalp, which will give them a feeling of being stimulated. This sham stimulation has been shown to effectively blind participants to group. Assessors will not be told the type of study being conducted.
| bimanual training | Behavioral | Participants will engage in movements that use both hands, by playing with toys and games. |
|
Measure of movement speed of affected hand
| Day before intervention begins, compared to day after intervention ends (six days after intervention begins) |
| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| D006429 | Hemiplegia |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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