tDCS and Bimanual Therapy for Children With Hemiplegic Cerebral Palsy

Burke Medical Research Institute

Status: Enrolling

Conditions: Cerebral Palsy; Spastic Hemiplegia; Spastic Hemiplegic Cerebral Palsy; Hemiplegic Cerebral Palsy; Spastic Hemiparesis

Treatments: Behavioral: bimanual training; Device: active transcranial direct current stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03402854

tDCS_bimanual

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups

Active tDCS + bimanual training

Experimental group

Description:

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.

Treatment:

Device: active transcranial direct current stimulation

Behavioral: bimanual training

Sham tDCS + bimanual training

Experimental group

Description:

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.

Treatment:

Behavioral: bimanual training