tDCS and Bimanual Therapy for Children With Hemiplegic Cerebral Palsy

Part of paid clinical trials in White Plains, New York.

Sponsor
Burke Medical Research Institute
Study ID
NCT03402854
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
6 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • active transcranial direct current stimulation — DEVICE
    Participants will receive 20 min of tDCS over the scalp during the first 20 min of bimanual training.
  • bimanual training — BEHAVIORAL
    Participants will engage in movements that use both hands, by playing with toys and games.

Study Details

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.

Key Dates

Start date
Dec 1, 2019
Status verified
Jul 2024
Primary completion
Jun 30, 2025
Completion
Aug 31, 2025

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Change in Assisting Hand Assessment [ Time Frame: Day before intervention begins, compared to day after intervention ends (six days after intervention begins) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Burke Medical Research InstituteWhite PlainsNew York10605
Kathleen M Friel, PhD
[email protected]
914-368-3116
Kathleen M Friel, PhD (PRINCIPAL_INVESTIGATOR)
Andrew M Gordon, PhD (SUB_INVESTIGATOR)

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Burke Medical Research Institute· White Plains, NY

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