Cerebral Palsy, Hemiplegic Cerebral Palsy, Spastic Hemiparesis, Spastic Hemiplegia, Spastic Hemiplegic Cerebral Palsy
Conditions
Keywords
pediatric, children, non-invasive brain stimulation, transcranial direct current stimulation, bimanual training, hand training
Brief summary
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.
Interventions
DEVICEactive transcranial direct current stimulation
Participants will receive 20 min of tDCS over the scalp during the first 20 min of bimanual training.
BEHAVIORALbimanual training
Participants will engage in movements that use both hands, by playing with toys and games.
Sponsors
University of Minnesota
Teachers College, Columbia University
Burke Medical Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
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.
Intervention model description
Children will be randomly allocated to one of two parallel arms of the study.
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of congenital hemiplegic cerebral palsy * Ability to lift and grasp light objects with affected hand * Ability to extend wrist of affected hand 15 degrees * Ability to follow instructions and provide informed assent * Parent(s) able to provide informed consent
Exclusion criteria
* Seizures after age 2 years * Spasticity medication within 6 months before study * Selective dorsal rhizotomy * Surgery in affected upper extremity within year before study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Assisting Hand Assessment | Day before intervention begins, compared to day after intervention ends (six days after intervention begins) | Measure of how well the child uses both hands cooperatively for bimanual activities |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Jebsen-Taylor Test of Hand Function | Day before intervention begins, compared to day after intervention ends (six days after intervention begins) | Measure of movement speed of affected hand |
| Box and Blocks test | Day before intervention begins, compared to day after intervention ends (six days after intervention begins) | Measure of movement speed of affected hand |
Countries
United States
Contacts
Primary ContactKathleen M Friel, PhD
Outcome results
None listed