Back to resultstDCS and Bimanual Therapy for Children With Hemiplegic Cerebral Palsy
Primary Purpose
Cerebral Palsy, Hemiplegic Cerebral Palsy, Spastic Hemiplegic Cerebral Palsy
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
active transcranial direct current stimulation
bimanual training
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring pediatric, children, non-invasive brain stimulation, transcranial direct current stimulation, bimanual training, hand training
Eligibility Criteria
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
Sites / Locations
- Burke Medical Research InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Active tDCS + bimanual training
Sham tDCS + bimanual training
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change in Assisting Hand Assessment
Measure of how well the child uses both hands cooperatively for bimanual activities
Secondary Outcome Measures
Jebsen-Taylor Test of Hand Function
Measure of movement speed of affected hand
Box and Blocks test
Measure of movement speed of affected hand
Full Information
NCT ID
NCT03402854
First Posted
January 10, 2018
Last Updated
July 11, 2023
Sponsor
Burke Medical Research Institute
Collaborators
University of Minnesota, Teachers College, Columbia University
1. Study Identification
Unique Protocol Identification Number
NCT03402854
Brief Title
tDCS and Bimanual Therapy for Children With Hemiplegic Cerebral Palsy
Official Title
tDCS and Bimanual Therapy for Children With Hemiplegic Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
August 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Burke Medical Research Institute
Collaborators
University of Minnesota, Teachers College, Columbia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Hemiplegic Cerebral Palsy, Spastic Hemiplegic Cerebral Palsy, Spastic Hemiparesis, Spastic Hemiplegia
Keywords
pediatric, children, non-invasive brain stimulation, transcranial direct current stimulation, bimanual training, hand training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Children will be randomly allocated to one of two parallel arms of the study.
Masking
ParticipantCare ProviderOutcomes 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.
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active tDCS + bimanual training
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham tDCS + bimanual training
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
active transcranial direct current stimulation
Intervention Description
Participants will receive 20 min of tDCS over the scalp during the first 20 min of bimanual training.
Intervention Type
Behavioral
Intervention Name(s)
bimanual training
Intervention Description
Participants will engage in movements that use both hands, by playing with toys and games.
Primary Outcome Measure Information:
Title
Change in Assisting Hand Assessment
Description
Measure of how well the child uses both hands cooperatively for bimanual activities
Time Frame
Day before intervention begins, compared to day after intervention ends (six days after intervention begins)
Secondary Outcome Measure Information:
Title
Jebsen-Taylor Test of Hand Function
Description
Measure of movement speed of affected hand
Time Frame
Day before intervention begins, compared to day after intervention ends (six days after intervention begins)
Title
Box and Blocks test
Description
Measure of movement speed of affected hand
Time Frame
Day before intervention begins, compared to day after intervention ends (six days after intervention begins)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kathleen M Friel, PhD
Phone
914-368-3116
Email
kaf3001@med.cornell.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen M Friel, PhD
Organizational Affiliation
Burke Medical Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Burke Medical Research Institute
City
White Plains
State/Province
New York
ZIP/Postal Code
10605
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathleen M Friel, PhD
Phone
914-368-3116
Email
kaf3001@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Kathleen M Friel, PhD
First Name & Middle Initial & Last Name & Degree
Andrew M Gordon, PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
35190424
Citation
Gordon AM, Ferre CL, Robert MT, Chin K, Brandao M, Friel KM. HABIT+tDCS: a study protocol of a randomised controlled trial (RCT) investigating the synergistic efficacy of hand-arm bimanual intensive therapy (HABIT) plus targeted non-invasive brain stimulation to improve upper extremity function in school-age children with unilateral cerebral palsy. BMJ Open. 2022 Feb 21;12(2):e052409. doi: 10.1136/bmjopen-2021-052409.
Results Reference
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tDCS and Bimanual Therapy for Children With Hemiplegic Cerebral Palsy
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