Cerebral PalsyNCT03402854
tDCS and Bimanual Therapy for Children With Hemiplegic Cerebral Palsy
A study testing active transcranial direct current stimulation and bimanual training in people with Cerebral Palsy and Hemiplegic Cerebral Palsy, run by Burke Medical Research Institute at 1 site in United States.
Trial summary
The goal of this study is to test the efficacy of transcranial direct current stimulation combined with bimanual training on hand function in children with unilateral spastic cerebral palsy (USCP). Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Cerebral Palsy, Hemiplegic Cerebral Palsy, Spastic Hemiplegic Cerebral Palsy
- What is being tested?
- active transcranial direct current stimulation and bimanual training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2019to 31 Aug 2025
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of congenital hemiplegic cerebral palsy
- Ability to lift and grasp light objects with affected hand
- Ability to extend wrist of affected hand 15 degrees
- Ability to follow instructions and provide informed assent
- Parent(s) able to provide informed consent
Who cannot join
- Seizures after age 2 years
- Spasticity medication within 6 months before study
- Selective dorsal rhizotomy
- Surgery in affected upper extremity within year before study
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Burke Medical Research Institute
White Plains, New York, 10605
Kathleen M Friel, PhD, 914-368-3116, kaf3001@med.cornell.edu
Kathleen M Friel, PhD
About this study
The goal of this study is to test the efficacy of transcranial direct current stimulation combined with bimanual training on hand function in children with unilateral spastic cerebral palsy (USCP). Children who enroll in the protocol will be randomized to receive either sham (not stimulating) tDCS plus bimanual training, or active (stimulating) tDCS plus bimanual training.
- Conditions
- Cerebral Palsy, Hemiplegic Cerebral Palsy, Spastic Hemiplegic Cerebral Palsy, Spastic Hemiparesis, Spastic Hemiplegia
- Being tested
- active transcranial direct current stimulation, bimanual training
- Keywords
- pediatric, children, non-invasive brain stimulation, transcranial direct current stimulation, bimanual training, hand training
- Medical subject headings
- Cerebral Palsy, Hemiplegia
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 the first 20 min of bimanual training.
bimanual trainingBehavioural
Participants will engage in movements that use both hands, by playing with toys and games.
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS + bimanual training | Experimental | In this arm, participants will engage in 120 min of bimanual training. Bimanual training involves using both hands to play with toys and games during the study. During the first 20 min of bimanual training, participants will receive active tDCS via sponges over the scalp. Receives: Device: active transcranial direct current stimulation; Behavioral: bimanual training |
| Sham tDCS + bimanual training | Experimental | In this arm, participants will engage in 120 min of bimanual training. Bimanual training involves using both hands to play with toys and games during the study. During the first 20 min of bimanual training, participants will wear the tDCS device that is worn by the active tDCS group, but in the sham group, participants will not receive stimulation during this 20 min period. Receives: Behavioral: bimanual training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Assisting Hand Assessment
Measure of how well the child uses both hands cooperatively for bimanual activities
Measured: Day before intervention begins, compared to day after intervention ends (six days after intervention begins)
Secondary outcomes (2)
Jebsen-Taylor Test of Hand Function
Measure of movement speed of affected hand
Measured: Day before intervention begins, compared to day after intervention ends (six days after intervention begins)
Box and Blocks test
Measure of movement speed of affected hand
Measured: Day before intervention begins, compared to day after intervention ends (six days after intervention begins)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2018
- Study start1 Dec 2019
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Model description
- Children will be randomly allocated to one of two parallel arms of the study.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Burke Medical Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Minnesota, Teachers College, Columbia University
- Responsible party
- Sponsor
- Investigators
- Kathleen M Friel, PhD, Principal investigator, Burke Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03402854
- Sponsor's protocol ID
- tDCS_bimanual
- Status last verified
- Jul 2024
- First submitted
- 10 Jan 2018
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will share IPD via the NIH Data Hub (DASH), which is sponsored by NICHD.
Publications
Gordon AM, Ferre CL, Robert MT, Chin K, Brandao M, Friel KM. HABIT+tDCS: a study protocol of a randomised controlled trial (RCT) investigating the synergistic efficacy of hand-arm bimanual intensive therapy (HABIT) plus targeted non-invasive brain stimulation to improve upper extremity function in school-age children with unilateral cerebral palsy. BMJ Open. 2022 Feb 21;12(2):e052409. doi: 10.1136/bmjopen-2021-052409.
PubMed 35190424Metelski N, Gordon AM, Ratnadurai-Giridharan S, Ferre CL, Robert MT, Friel KM. Heterogeneous Recruitment Curve Responses to Anodal Transcranial Direct Current Stimulation in Children With Unilateral Spastic Cerebral Palsy. Neurorehabil Neural Repair. 2026 Jul 16:15459683261464051. doi: 10.1177/15459683261464051. Online ahead of print.
PubMed 42464518
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- tDCS and Bimanual Therapy for Children With Hemiplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT03402854
- Acronym / sponsor ID
- tDCS_bimanual
- Conditions
- Cerebral Palsy, Hemiplegic Cerebral Palsy, Spastic Hemiplegic Cerebral Palsy, Spastic Hemiparesis, Spastic Hemiplegia
- Keywords
- pediatric, children, non-invasive brain stimulation, transcranial direct current stimulation, bimanual training, hand training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Burke Medical Research InstituteUniversity, hospital or other
- Collaborators
- University of Minnesota, Teachers College, Columbia University
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 18 Jan 2018 (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 efficacy of transcranial direct current stimulation combined with bimanual training on hand function in children with unilateral spastic cerebral palsy (USCP). Children who enroll in the protocol will be randomized to receive either sham (not stimulating) tDCS plus bimanual training, or active (stimulating) tDCS plus bimanual training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Children will be randomly allocated to one of two parallel arms of the study.
| Arm | Type | Receives |
|---|---|---|
| Active tDCS + bimanual training | Experimental | Device: active transcranial direct current stimulation, Behavioral: bimanual trainingIn this arm, participants will engage in 120 min of bimanual training. Bimanual training involves using both hands to play with toys and games during the study. During the first 20 min of bimanual training, participants will receive active tDCS via sponges over the scalp. |
| Sham tDCS + bimanual training | Experimental | Behavioral: bimanual trainingIn this arm, participants will engage in 120 min of bimanual training. Bimanual training involves using both hands to play with toys and games during the study. During the first 20 min of bimanual training, participants will wear the tDCS device that is worn by the active tDCS group, but in the sham group, participants will not receive stimulation during this 20 min period. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Diagnosis of congenital hemiplegic cerebral palsy
- Ability to lift and grasp light objects with affected hand
- Ability to extend wrist of affected hand 15 degrees
- Ability to follow instructions and provide informed assent
- Parent(s) able to provide informed consent
Key exclusion criteria (4 listed)
- Seizures after age 2 years
- Spasticity medication within 6 months before study
- Selective dorsal rhizotomy
- Surgery in affected upper extremity within year before study
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 the first 20 min of bimanual training. | Device | Active tDCS + bimanual training |
| bimanual trainingParticipants will engage in movements that use both hands, by playing with toys and games. | Behavioural | Active tDCS + bimanual training, Sham tDCS + bimanual training |
Primary outcome
Change in Assisting Hand Assessment
Time frame: Day before intervention begins, compared to day after intervention ends (six days after intervention begins)
Measure of how well the child uses both hands cooperatively for bimanual activities
2 secondary outcomes
Jebsen-Taylor Test of Hand Function
Time frame: Day before intervention begins, compared to day after intervention ends (six days after intervention begins)
Box and Blocks test
Time frame: Day before intervention begins, compared to day after intervention ends (six days after intervention begins)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Background: PubMed 35190424Gordon AM, Ferre CL, Robert MT, Chin K, Brandao M, Friel KM. HABIT+tDCS: a study protocol of a randomised controlled trial (RCT) investigating the synergistic efficacy of hand-arm bimanual intensive therapy (HABIT) plus targeted non-invasive brain stimulation to improve upper extremity function in school-age children with unilateral cerebral palsy. BMJ Open. 2022 Feb 21;12(2):e052409. doi: 10.1136/bmjopen-2021-052409.
- Derived from this study: PubMed 42464518Metelski N, Gordon AM, Ratnadurai-Giridharan S, Ferre CL, Robert MT, Friel KM. Heterogeneous Recruitment Curve Responses to Anodal Transcranial Direct Current Stimulation in Children With Unilateral Spastic Cerebral Palsy. Neurorehabil Neural Repair. 2026 Jul 16:15459683261464051. doi: 10.1177/15459683261464051. Online ahead of print.
- Individual participant dataSharing planned: Yes. The investigators will share IPD via the NIH Data Hub (DASH), which is sponsored by NICHD.
Related trials for Cerebral Palsy
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
Recruiting
Sensory Integration Therapy vs Conventional Physical Therapy in Children With Mixed Cerebral Palsy
Cerebral Palsy
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
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.
Kathleen M Friel, PhD principal investigator
Burke Medical Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active transcranial direct current stimulation and bimanual training in people with Cerebral Palsy and Hemiplegic Cerebral Palsy, run by Burke Medical Research Institute 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 4 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: status not confirmed, as of the sponsor's last update on 16 Jul 2024. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kathleen M Friel, PhD (914-368-3116, kaf3001@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Assisting Hand Assessment (time frame: Day before intervention begins, compared to day after intervention ends (six days after intervention begins)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03402854, which also lists 2 linked publications.
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 16 Jul 2024.