Cerebral pAlsy Motor Promotion With Transcranial Direct Current Stimulation (CAMP-tDCS)

NCT ID: NCT06239675

Last Updated: 2025-07-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2027-12-31

Brief Summary

This study aims to test if transcranial direct current stimulation (tDCS) can be applied to boost the efficacy of constraint-induced movement therapy (CIMT) in children with HCP and examine brain mechanisms related to individual outcomes.

Detailed Description

Currently, clinical treatment of hand/arm motor deficits in children affected by cerebral palsy is mainly rehabilitation and behaviorally oriented. Constraint-induced movement therapy (CIMT) has emerged as a frequently used rehabilitation intervention in children with hemiplegic cerebral palsy (HCP). In CIMT sessions, the unaffected upper limb is restrained with a cast or similar device, and the affected hand/arm is intensively and structurally trained. With different variations, such as constraint and intensity, CIMT has been demonstrated to be efficacious in improving hand-and-arm use in children with HCP. However, clinical outcomes across individuals who receive CIMT can show vast variation. How to improve the efficacy of CIMT and reduce individual variation will be of direct and profound clinical impacts. Motor deficits of children with HCP have a source origin of early brain injury, which often disrupts some regions of the brain and can cause changes in brain functions. Alteration or normalization of brain neuronal activities may influence motor functions in children with HCP and might boost the efficacy of CIMT. Transcranial direct current stimulation (tDCS), a type of non-invasive weak electric stimulation, has been demonstrated to be capable of influencing cognition and behaviors in abundant laboratory research tasks, hinting at potential clinical effects. Specific to the pediatric population with HCP, a few preliminary studies have tested the safety of tDCS when applied in children with HCP. This study will test how tDCS influences the efficacy of CIMT in children with HCP by comparing motor performances between two groups. The first group of children with HCP will receive anodal tDCS and CIMT while the second group of children with HCP will receive sham tDCS and CIMT during the intervention phase.

Conditions

Cerebral Palsy, Hemiplegic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

tDCS+CIMT

Participants will receive concurrent anodal tDCS (20 minutes, 1mA\~2mA) and CIMT (2 hours) five days a week for three weeks in a row.

Group Type: EXPERIMENTAL

tDCS

Intervention Type: DEVICE

tDCS will be delivered anodal for 20 minutes at an intensity between 1mA and 2mA for 15 sessions.

CIMT

Intervention Type: BEHAVIORAL

CIMT will be administered for two hours a day, five days a week, and three weeks in a row.

sham+CIMT

Participants will receive concurrent sham tDCS and CIMT (2 hours) five days a week for three weeks in a row.

Group Type: SHAM_COMPARATOR

CIMT

Intervention Type: BEHAVIORAL

CIMT will be administered for two hours a day, five days a week, and three weeks in a row.

sham tDCS

Intervention Type: DEVICE

sham tDCS

Interventions

tDCS

tDCS will be delivered anodal for 20 minutes at an intensity between 1mA and 2mA for 15 sessions.

Intervention Type: DEVICE

CIMT

CIMT will be administered for two hours a day, five days a week, and three weeks in a row.

Intervention Type: BEHAVIORAL

sham tDCS

sham tDCS

Intervention Type: DEVICE

Other Intervention Names

transcranial direct current stimulation; constraint induced movement therapy

Eligibility Criteria

Inclusion Criteria

• formal diagnosis of hemiplegic cerebral palsy
• unilateral upper limb (arm and hand) motor and sensory impairments
• capable of understanding and following experimental instructions and procedures
• capable of performing study procedures without assistance
• 5-17 years of age, including 5-year-old and 17-year-old

Exclusion Criteria

• brain surgery, peripheral nerve surgery, genetic disorders, other neurological disorders or injuries
• muscle toxin injection within six months before recruitment
• received constraint-induced movement therapy (CIMT) within one year before recruitment
• uncontrolled seizures within one year before recruitment
• orthopedic surgery in upper limb within one year before recruitment
• incapable of understanding and following experimental instructions and procedures
• non-removable metallic objects or infusion pumps in the body
• psychoactive or myorelaxant medication during study procedures
• less than five years of age and older than 17 years of age

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Health

OTHER

Sponsor Role: collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Yanlong Song

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yanlong Song, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Locations

Children's Health Medical Center Dallas

Dallas, Texas, United States

Countries

United States

Other Identifiers

STU-2023-0925

Identifier Type: -

Identifier Source: org_study_id