Trials Today

tDCS and Bimanual Therapy for Children With Hemiplegic Cerebral Palsy

Purpose

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.

Conditions

Cerebral Palsy
Hemiplegic Cerebral Palsy
Spastic Hemiplegic Cerebral Palsy
Spastic Hemiparesis
Spastic Hemiplegia

Eligibility

Eligible Ages: Between 6 Years and 18 Years
Eligible Sex: All
Accepts 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

Study Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Children will be randomly allocated to one of two parallel arms of the study.
Primary Purpose: Treatment
Masking: Triple (Participant, Care Provider, 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.

Arm Groups

Arm	Description	Assigned Intervention
Experimental Active tDCS + 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.	Device: active transcranial direct current stimulation Participants will receive 20 min of tDCS over the scalp during the first 20 min of bimanual training. Behavioral: bimanual training Participants will engage in movements that use both hands, by playing with toys and games.
Experimental Sham tDCS + 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.	Behavioral: bimanual training Participants will engage in movements that use both hands, by playing with toys and games.

Recruiting Locations

Burke Medical Research Institute
White Plains, New York 10605

Contact:
Kathleen M Friel, PhD
914-368-3116
kaf3001@med.cornell.edu

More Details

NCT ID: NCT03402854
Status: Recruiting
Sponsor: Burke Medical Research Institute

Study Contact

Kathleen M Friel, PhD
914-368-3116
kaf3001@med.cornell.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.