tDCS and Bimanual Therapy for Children With Hemiplegic Cerebral Palsy

NCT ID: NCT03402854

Last Updated: 2024-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-01

Study Completion Date

2025-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cerebral Palsy Hemiplegic Cerebral Palsy Spastic Hemiplegic Cerebral Palsy Spastic Hemiparesis Spastic Hemiplegia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Children will be randomly allocated to one of two parallel arms of the study.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
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.

Study Groups

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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.

Group Type EXPERIMENTAL

active transcranial direct current stimulation

Intervention Type DEVICE

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

bimanual training

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

bimanual training

Intervention Type BEHAVIORAL

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

Interventions

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active transcranial direct current stimulation

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

Intervention Type DEVICE

bimanual training

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Minnesota

OTHER

Sponsor Role collaborator

Teachers College, Columbia University

OTHER

Sponsor Role collaborator

Burke Medical Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kathleen M Friel, PhD

Role: PRINCIPAL_INVESTIGATOR

Burke Medical Research Institute

Locations

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Burke Medical Research Institute

White Plains, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kathleen M Friel, PhD

Role: CONTACT

914-368-3116

Facility Contacts

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Kathleen M Friel, PhD

Role: primary

914-368-3116

References

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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.

Reference Type BACKGROUND
PMID: 35190424 (View on PubMed)

Other Identifiers

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tDCS_bimanual

Identifier Type: -

Identifier Source: org_study_id

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