tDCS and Bimanual Therapy for Children With Hemiplegic Cerebral Palsy

Not Applicable

Recruiting

• Conditions: Hemiplegic Cerebral Palsy; Cerebral Palsy; Spastic Hemiplegic Cerebral Palsy; Spastic Hemiparesis; Spastic Hemiplegia
• Interventions: Behavioral: bimanual training; Device: active transcranial direct current stimulation

• Registration Number: NCT03402854
• Lead Sponsor: Burke Medical Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-10
• Study First Submitted QC: 2018-01-17
• Study First Posted: 2018-01-18
• Study Start: 2019-12-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-15
• Last Update Posted: 2024-07-16
• Primary Completion: 2025-06-30
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham tDCS + bimanual training	bimanual training	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.
Active tDCS + bimanual training	bimanual training	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.
Active tDCS + bimanual training	active transcranial direct current stimulation	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Burke Medical Research Institute; 🇺🇸 White Plains, New York, United States