Cerebral Palsy, HemiplegicNCT06239675
Cerebral pAlsy Motor Promotion With Transcranial Direct Current Stimulation (CAMP-tDCS)
A study testing tDCS and CIMT in people with Cerebral Palsy, Hemiplegic, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Cerebral Palsy, Hemiplegic
- What is being tested?
- tDCS and CIMT
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Health Medical Center Dallas
Dallas, Texas, 75235
About this study
Official title: 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.
Read the 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
- Being tested
- tDCS, CIMT, sham tDCS
- Keywords
- children
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
Also called transcranial direct current stimulation
tDCS will be delivered anodal for 20 minutes at an intensity between 1mA and 2mA for 15 sessions.
CIMTBehavioural
Also called constraint induced movement therapy
CIMT will be administered for two hours a day, five days a week, and three weeks in a row.
sham tDCSDevice
sham tDCS
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: CIMT; Device: sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
It will be subjectively assessed with the Quality of Upper Extremity Skill Test (QUEST) to measure functions and use of both upper limbs.
Measured: 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
It will be measured with a two-point discriminator to assess the minimal displacement between two points of touch on fingertip one can perceive.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start1 Jan 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Why it stopped: No funds are available to support implementation of this project.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy, HemiplegicStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Health
- Responsible party
- Principal investigator, Yanlong Song, University of Texas Southwestern Medical Center
- Investigators
- Yanlong Song, PhD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06239675
- Sponsor's protocol ID
- STU-2023-0925
- Status last verified
- Jul 2025
- First submitted
- 17 Jan 2024
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06239675
- Acronym / sponsor ID
- STU-2023-0925
- Conditions
- Cerebral Palsy, Hemiplegic
- Keywords
- children
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funds are available to support implementation of this project.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Children's Health
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tDCS+CIMT | Experimental | Device: tDCS, Behavioral: CIMTParticipants will receive concurrent anodal tDCS (20 minutes, 1mA~2mA) and CIMT (2 hours) five days a week for three weeks in a row. |
| sham+CIMT | Sham comparator | Behavioral: CIMT, Device: sham tDCSParticipants will receive concurrent sham tDCS and CIMT (2 hours) five days a week for three weeks in a row. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCSAlso: transcranial direct current stimulationtDCS will be delivered anodal for 20 minutes at an intensity between 1mA and 2mA for 15 sessions. | Device | tDCS+CIMT |
| CIMTAlso: constraint induced movement therapyCIMT will be administered for two hours a day, five days a week, and three weeks in a row. | Behavioural | sham+CIMT, tDCS+CIMT |
| sham tDCSsham tDCS | Device | sham+CIMT |
Primary outcome
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.
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.
2 secondary outcomes
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.
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yanlong Song, PhD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS and CIMT in people with Cerebral Palsy, Hemiplegic, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025; AzTrials last refreshed its copy on 6 Nov 2026.