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

NCT06239675 | Withdrawn FDA Device

• 1 other identifier: STU-2023-0925
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy, Hemiplegic

Keywords

children

Outcome Measures

Primary Outcomes (2)

• gross manual dexterity

  It will be measured by the box and block test to assess how many blocks one can move from one box to another in one minute.

  With the first day of the intervention defined as day 1, this measure will be assessed in one of the three days before day 1, on day 15 or day 16 or day 17, and on day 181 or day 182 or day 183.

• fine manual dexterity

  It will be measured by the nine-hole peg test to assess the time one needs to place nine pins into a reservior.

  With the first day of the intervention defined as day 1, this measure will be assessed in one of the three days before day 1, on day 15 or day 16 or day 17, and on day 181 or day 182 or day 183.

Secondary Outcomes (2)

• quality of upper extremity skill

  With the first day of the intervention defined as day 1, this measure will be assessed in one of the three days before day 1, on day 15 or day 16 or day 17, and on day 181 or day 182 or day 183.

• finger touch sensitivity

  With the first day of the intervention defined as day 1, this measure will be assessed in one of the three days before day 1, on day 15 or day 16 or day 17, and on day 181 or day 182 or day 183.

Study Arms (2)

tDCS+CIMT

EXPERIMENTAL

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

Device: tDCS; Behavioral: CIMT

sham+CIMT

SHAM COMPARATOR

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

Behavioral: CIMT; Device: sham tDCS

Interventions

tDCS DEVICE

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

Also known as: transcranial direct current stimulation

tDCS+CIMT

CIMT BEHAVIORAL

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

Also known as: constraint induced movement therapy

sham+CIMT; tDCS+CIMT

sham tDCS DEVICE

sham tDCS

sham+CIMT

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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
• years of age, including 5-year-old and 17-year-old

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Children's Health: collaborator

Study Sites (1)

Children's Health Medical Center Dallas

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Transcranial Direct Current Stimulation; Constraint Induced Movement Therapy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Exercise Therapy; Physical Therapy Modalities; Rehabilitation

Study Officials

• Yanlong Song, PhD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: February 2, 2024
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: IPD and supporting information will be shared at the end of the study.
• Access Criteria: Access to the shared IPD and supporting information will not be controlled.

Locations

US (1)