Recruiting

tDCS & Bimanual Training

Sponsor:

Burke Medical Research Institute

Code:

NCT03402854

Conditions

Cerebral Palsy

Hemiplegic Cerebral Palsy

Spastic Hemiplegic Cerebral Palsy

Spastic Hemiparesis

Spastic Hemiplegia

Eligibility Criteria

Sex: All

Age: 6 - 18

Healthy Volunteers: Not accepted

Interventions

active transcranial direct current stimulation

bimanual training

Study Details

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.

Conditions

Cerebral Palsy

Hemiplegic Cerebral Palsy

Spastic Hemiplegic Cerebral Palsy

Spastic Hemiparesis

Spastic Hemiplegia

Study ID

NCT03402854

Start date

Dec 1, 2019

Status verified date

Jul, 2024

Completion date

Aug 31, 2025

Anticipated

Primary completion date

Jun 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 18

Healthy Volunteers: Not accepted

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

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

active transcranial direct current stimulation

Participants will receive 20 min of tDCS over the scalp during the first 20 min of bimanual training.

bimanual training

Participants will engage in movements that use both hands, by playing with toys and games.

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 and Locations

Central contacts

Kathleen M Friel, PhD

914-368-3116kaf3001@med.cornell.edu

Locations

Burke Medical Research Institute

Recruiting

White Plains, New York, United States, 10605

Contacts

Kathleen M Friel, PhD

914-368-3116kaf3001@med.cornell.edu

Principal Investigator:

Kathleen M Friel, PhD

More Information

Sponsor

Burke Medical Research Institute

Last update posted

Jul 16, 2024

Last verified

Jul, 2024

Keywords

  • pediatric
  • children
  • non-invasive brain stimulation
  • transcranial direct current stimulation
  • bimanual training
  • hand training

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Burke Medical Research Institute on 2024-07-16.