tDCS and Bimanual Therapy for Children With Hemiplegic Cerebral Palsy

Study Overview
=================
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.

Official Title
-----------------
tDCS and Bimanual Therapy for Children With Hemiplegic Cerebral Palsy

Conditions
-----------------
Cerebral Palsy, Hemiplegic Cerebral Palsy, Spastic Hemiplegic Cerebral Palsy, Spastic Hemiparesis, Spastic Hemiplegia

Intervention / Treatment
-----------------
* Device: active transcranial direct current stimulation
* Behavioral: bimanual training


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Children will be randomly allocated to one of two parallel arms of the study.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active tDCS + bimanual training<br>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. | Device: active transcranial direct current stimulation<br>* Participants will receive 20 min of tDCS over the scalp during the first 20 min of bimanual training.<br>Behavioral: bimanual training<br>* Participants will engage in movements that use both hands, by playing with toys and games.<br>|
| Experimental: Sham tDCS + bimanual training<br>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. | Behavioral: bimanual training<br>* Participants will engage in movements that use both hands, by playing with toys and games.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | Measure of movement speed of affected hand | Day before intervention begins, compared to day after intervention ends (six days after intervention begins) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bimanual training, hand training, pediatric, children, non-invasive brain stimulation, transcranial direct current stimulation