tDCS and Bimanual Therapy for Children With Hemiplegic Cerebral Palsy

NCT03402854 | Recruiting

• 1 other identifier: tDCS_bimanual
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Jebsen-Taylor Test of Hand Function

  Day before intervention begins, compared to day after intervention ends (six days after intervention begins)

• Box and Blocks test

  Day before intervention begins, compared to day after intervention ends (six days after intervention begins)

Study Arms (2)

Active tDCS + bimanual training

EXPERIMENTAL

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; Behavioral: bimanual training

Sham tDCS + bimanual training

EXPERIMENTAL

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

Interventions

active transcranial direct current stimulation DEVICE

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

Active tDCS + bimanual training

bimanual training BEHAVIORAL

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

Active tDCS + bimanual training; Sham tDCS + bimanual training

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Seizures after age 2 years
• Spasticity medication within 6 months before study
• Selective dorsal rhizotomy
• Surgery in affected upper extremity within year before study

Sponsors & Collaborators

• Burke Medical Research Institute: lead
• University of Minnesota: collaborator
• Teachers College, Columbia University: collaborator

Study Sites (1)

Burke Medical Research Institute

White Plains, New York, 10605, United States

RECRUITING

Related 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.

  PMID: 35190424 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy; Hemiplegia

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kathleen M Friel, PhD

  Burke Medical Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathleen M Friel, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Children will be randomly allocated to one of two parallel arms of the study.

Study Record Dates

• First Submitted: January 10, 2018
• First Posted: January 18, 2018
• Study Start: December 1, 2019
• Primary Completion: June 30, 2025
• Study Completion: August 31, 2025
• Last Updated: July 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available when study is complete, and remain in DASH indefinitely.

Locations

US (1)