Cerebral PalsyNCT04725019
Enhancing Motor Learning in Children With Cerebral Palsy Using Transcranial Direct-current Stimulation
A study testing active transcranial direct current stimulation and Motor training in people with Cerebral Palsy, run by Boston University Charles River Campus.
Trial summary
The goal of this study is to test the effects of transcranial direct current stimulation (tDCS) on motor learning and brain plasticity in children with unilateral spastic cerebral palsy (USCP). Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- active transcranial direct current stimulation and Motor training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2023to 31 Jul 2026
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children between 6-17 years old who have been diagnosed with cerebral palsy, with the following joint mobility: wrist extension 20º, metacarpophalangeal and proximal interphalangeal joints 10º. Ability to cooperate and follow simple directions.
Who cannot join
- Seizure beyond age 2, use of anti-seizure medication, history or family history of epilepsy, cranial metal implants, structural brain lesion, devices that may be affected by tDCS or TMS (pacemaker, medication pump, cochlear implant, implanted brain stimulator)
- True positive response on the Transcranial Magnetic Stimulation and MRI Safety Screen
- Current use of medications known to lower the seizure threshold
- Previous episode of unprovoked neurocardiogenic syncope
- Indwelling metal or incompatible medical devices
- Centrally-acting medications including anti-seizure medications
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- Evidence of scalp disease or skin abnormalities
- Current medical illness unrelated to CP
- High motor ability in affected arm (i.e. no asymmetry in scores of hand function)
- Severe spasticity
- Lack of asymmetry in hand function
- Orthopedic surgery in affected arm
- Botulinum toxin therapy in either upper extremity during last 6 months, or planned during study period
- Currently receiving intrathecal baclofen
- History of broken arm (either arm) 1 year prior to study enrollment
About this study
The goal of this study is to test the effects of transcranial direct current stimulation (tDCS) on motor learning and brain plasticity in children with unilateral spastic cerebral palsy (USCP).
- Conditions
- Cerebral Palsy
- Being tested
- active transcranial direct current stimulation, Motor training
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active transcranial direct current stimulationDevice
Participants will receive 20 min of tDCS over the scalp during 20 min of motor training.
Motor trainingBehavioural
Participants will engage in a high number of repetition of movements that use both hands while playing with toys and games. Training will be provided 20 min/day, for 5 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS + motor training | Experimental | In this arm, participants will receive 20 minutes of active tDCS and motor training that involves a high number of repetitions while engaged in child-friendly games. Receives: Device: active transcranial direct current stimulation; Behavioral: Motor training |
| Sham tDCS + motor training | Experimental | In this arm, participants will receive 20 minutes of sham tDCS and motor training that involves a high number of repetitions while engaged in child-friendly games. Children receiving sham tDCS will wear the tDCS device but not receive active stimulation. Receives: Behavioral: Motor training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the Assisting Hand Assessment
Investigators will measure changes in how well the child uses both hands cooperatively for bimanual activities.
Measured: Day before intervention begins, compared to day after intervention ends (approximately 1 week)
Changes in the Box and Blocks test
Investigators will measure changes in the movement speed of the hands.
Measured: Day before intervention begins, compared to day after intervention ends (approximately 1 week)
Secondary outcomes (1)
Changes in Motor-evoked Potential assessment
Investigators will measure change in measurements of cortical excitability using transcranial magnetic stimulation (TMS) from baseline to follow-up (1 week).
Measured: Day before intervention begins, compared to day after intervention ends (approximately 1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start1 Mar 2023 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Why it stopped: Funding was not obtained so the study could not be conducted.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claudio Ferre, PhD, Principal investigator, Boston University Charles River Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04725019
- Sponsor's protocol ID
- 5825
- Status last verified
- Jan 2023
- First submitted
- 19 Jan 2021
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Motor Learning in Children With Cerebral Palsy Using Transcranial Direct-current Stimulation
- ClinicalTrials.gov ID
- NCT04725019
- Acronym / sponsor ID
- 5825
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding was not obtained so the study could not be conducted.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 26 Jan 2021 (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.
The goal of this study is to test the effects of transcranial direct current stimulation (tDCS) on motor learning and brain plasticity in children with unilateral spastic cerebral palsy (USCP).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tDCS + motor training | Experimental | Device: active transcranial direct current stimulation, Behavioral: Motor trainingIn this arm, participants will receive 20 minutes of active tDCS and motor training that involves a high number of repetitions while engaged in child-friendly games. |
| Sham tDCS + motor training | Experimental | Behavioral: Motor trainingIn this arm, participants will receive 20 minutes of sham tDCS and motor training that involves a high number of repetitions while engaged in child-friendly games. Children receiving sham tDCS will wear the tDCS device but not receive active stimulation. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children between 6-17 years old who have been diagnosed with cerebral palsy, with the following joint mobility: wrist extension 20º, metacarpophalangeal and proximal interphalangeal joints 10º. Ability to cooperate and follow simple directions.
Key exclusion criteria (15 listed)
- Seizure beyond age 2, use of anti-seizure medication, history or family history of epilepsy, cranial metal implants, structural brain lesion, devices that may be affected by tDCS or TMS (pacemaker, medication pump, cochlear implant, implanted brain stimulator)
- True positive response on the Transcranial Magnetic Stimulation and MRI Safety Screen
- Current use of medications known to lower the seizure threshold
- Previous episode of unprovoked neurocardiogenic syncope
- Indwelling metal or incompatible medical devices
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 |
|---|---|---|
| active transcranial direct current stimulationParticipants will receive 20 min of tDCS over the scalp during 20 min of motor training. | Device | Active tDCS + motor training |
| Motor trainingParticipants will engage in a high number of repetition of movements that use both hands while playing with toys and games. Training will be provided 20 min/day, for 5 consecutive days. | Behavioural | Active tDCS + motor training, Sham tDCS + motor training |
Primary outcome
Changes in the Assisting Hand Assessment
Time frame: Day before intervention begins, compared to day after intervention ends (approximately 1 week)
Investigators will measure changes in how well the child uses both hands cooperatively for bimanual activities.
Changes in the Box and Blocks test
Time frame: Day before intervention begins, compared to day after intervention ends (approximately 1 week)
Investigators will measure changes in the movement speed of the hands.
1 secondary outcome
Changes in Motor-evoked Potential assessment
Time frame: Day before intervention begins, compared to day after intervention ends (approximately 1 week)
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 13 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Claudio Ferre, PhD principal investigator
Boston University Charles River Campus
Questions about this trial
What is this clinical trial studying?
A study testing active transcranial direct current stimulation and Motor training in people with Cerebral Palsy, run by Boston University Charles River Campus.
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 1 inclusion and 15 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 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Changes in the Assisting Hand Assessment (time frame: Day before intervention begins, compared to day after intervention ends (approximately 1 week)). 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 13 Aug 2026.