tDCS and Bimanual Therapy for Children With Hemiplegic Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

tDCS and Bimanual Therapy for Children With Hemiplegic Cerebral Palsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03402854
• Other study ID #: tDCS_bimanual
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: August 31, 2025

Study information

• Verified date: July 2023
• Source: Burke Medical Research Institute
• Contact: Kathleen M Friel, PhD
• Phone: 914-368-3116
• Email: kaf3001[@]med.cornell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 31, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Hemiplegia
• Hemiplegic Cerebral Palsy
• Muscle Spasticity
• Paralysis
• Paresis
• Spastic Hemiparesis
• Spastic Hemiplegia
• Spastic Hemiplegic Cerebral Palsy

Intervention

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.

Locations

Country	Name	City	State
United States	Burke Medical Research Institute	White Plains	New York

Sponsors (3)

Lead Sponsor	Collaborator
Burke Medical Research Institute	Teachers College, Columbia University, University of Minnesota

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Assisting Hand Assessment	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	Jebsen-Taylor Test of Hand Function	Measure of movement speed of affected hand	Day before intervention begins, compared to day after intervention ends (six days after intervention begins)
Secondary	Box and Blocks test	Measure of movement speed of affected hand	Day before intervention begins, compared to day after intervention ends (six days after intervention begins)