- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03402854
tDCS and Bimanual Therapy for Children With Hemiplegic Cerebral Palsy
July 11, 2023 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
- Name: Kathleen M Friel, PhD
- Phone Number: 914-368-3116
- Email: kaf3001@med.cornell.edu
Study Locations
-
-
New York
-
White Plains, New York, United States, 10605
- Recruiting
- Burke Medical Research Institute
-
Contact:
- Kathleen M Friel, PhD
- Phone Number: 914-368-3116
- Email: kaf3001@med.cornell.edu
-
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.
|
Participants will receive 20 min of tDCS over the scalp during the first 20 min of 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.
|
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
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.
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, 2024
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 13, 2023
Last Update Submitted That Met QC Criteria
July 11, 2023
Last Verified
July 1, 2023
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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