tDCS and Bimanual Therapy for Children With Hemiplegic Cerebral Palsy

July 15, 2024 updated by: Burke Medical Research Institute
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • White Plains, New York, United States, 10605
        • Recruiting
        • Burke Medical Research Institute
        • Contact:
        • Principal Investigator:
          • Kathleen M Friel, PhD
        • Sub-Investigator:
          • Andrew M Gordon, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Jebsen-Taylor Test of Hand Function
Time Frame: Day before intervention begins, compared to day after intervention ends (six days after intervention begins)
Measure of movement speed of affected hand
Day before intervention begins, compared to day after intervention ends (six days after intervention begins)
Box and Blocks test
Time Frame: Day before intervention begins, compared to day after intervention ends (six days after intervention begins)
Measure of movement speed of affected hand
Day before intervention begins, compared to day after intervention ends (six days after intervention begins)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Burke Medical Research Institute

Collaborators

University of Minnesota
Teachers College, Columbia University

Investigators

  • Principal Investigator: Kathleen M Friel, PhD, Burke Medical Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2019

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

August 31, 2025

Study Registration Dates

First Submitted

January 10, 2018

First Submitted That Met QC Criteria

January 17, 2018

First Posted (Actual)

January 18, 2018

Study Record Updates

Last Update Posted (Actual)

July 16, 2024

Last Update Submitted That Met QC Criteria

July 15, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • tDCS_bimanual

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The investigators will share IPD via the NIH Data Hub (DASH), which is sponsored by NICHD.

IPD Sharing Time Frame

Data will be available when study is complete, and remain in DASH indefinitely.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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