Cerebral pAlsy Motor Promotion With Transcranial Direct Current Stimulation (CAMP-tDCS)
July 7, 2025 updated by: Yanlong Song, University of Texas Southwestern Medical Center
Concurrent Transcranial Direct Current Stimulation and Constraint-induced Movement Therapy in Children With Hemiplegic Cerebral Palsy: A Randomized Controlled Study on Efficacy and Brain Mechanisms
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75235
- Children's Health Medical Center Dallas
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
tDCS will be delivered anodal for 20 minutes at an intensity between 1mA and 2mA for 15 sessions.
Other Names:
CIMT will be administered for two hours a day, five days a week, and three weeks in a row.
Other Names:
|
|
Sham Comparator: sham+CIMT
Participants will receive concurrent sham tDCS and CIMT (2 hours) five days a week for three weeks in a row.
|
sham tDCS
CIMT will be administered for two hours a day, five days a week, and three weeks in a row.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
gross manual dexterity
Time Frame: 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.
|
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
Time Frame: 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.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
quality of upper extremity skill
Time Frame: 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.
|
It will be subjectively assessed with the Quality of Upper Extremity Skill Test (QUEST) to measure functions and use of both upper limbs.
|
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
Time Frame: 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.
|
It will be measured with a two-point discriminator to assess the minimal displacement between two points of touch on fingertip one can perceive.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Yanlong Song, PhD, University of Texas Southwestern Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
January 1, 2026
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Study Registration Dates
First Submitted
January 17, 2024
First Submitted That Met QC Criteria
February 1, 2024
First Posted (Actual)
February 2, 2024
Study Record Updates
Last Update Posted (Actual)
July 10, 2025
Last Update Submitted That Met QC Criteria
July 7, 2025
Last Verified
July 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU-2023-0925
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Participants' identifiers and linkages between study IDs and participants' identifiers will not be shared to protect participants' privacy, rights, and confidentiality.
All other individual participant data will be preserved and shared.
All data to be shared will be de-identified prior to receipt by any data repository.
The information needed to generate a global unique identifier for a repository will be kept for each participant.
IPD Sharing Time Frame
IPD and supporting information will be shared at the end of the study.
IPD Sharing Access Criteria
Access to the shared IPD and supporting information will not be controlled.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.