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Status unknownNCT03402854Updated Jul 16, 2024

tDCS and Bimanual Therapy for Children With Hemiplegic Cerebral Palsy

An interventional study of active transcranial direct current stimulation and bimanual training in Cerebral Palsy, Hemiplegic Cerebral Palsy and Spastic Hemiplegic Cerebral Palsy, sponsored by Burke Medical Research Institute. Status unknown at 1 site in United States. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-07-16.

Sponsored by Burke Medical Research Institute · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2024), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
6 Years to 18 Years
Sex
All
01

Study 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). 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.

02

Conditions studied

  • 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
03

In context

Cerebral Palsy

1,891 studies on the registry are indexed under Cerebral Palsy; 439 are open to participants now.

This study's planned enrollment of 80 is above the median of 34 across 1,396 interventional studies indexed under Cerebral Palsy.

Browse Cerebral Palsy studies →

Lead sponsor

Burke Medical Research Institute is the lead sponsor of 15 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Seizures after age 2 years
  • Spasticity medication within 6 months before study
  • Selective dorsal rhizotomy
  • Surgery in affected upper extremity within year before study
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Active tDCS + bimanual training

    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.

    Device: active transcranial direct current stimulation · Behavioral: bimanual training

  • Experimental
    Sham tDCS + bimanual training

    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.

    Behavioral: bimanual training

Interventions

  • Deviceactive transcranial direct current stimulation

    Participants will receive 20 min of tDCS over the scalp during the first 20 min of bimanual training.

  • Behavioralbimanual training

    Participants will engage in movements that use both hands, by playing with toys and games.

06

What researchers measure

Primary outcomes

  1. Change in Assisting Hand Assessment

    Measure of how well the child uses both hands cooperatively for bimanual activities

    Time frame: Day before intervention begins, compared to day after intervention ends (six days after intervention begins)

Secondary outcomes

  1. Jebsen-Taylor Test of Hand Function

    Measure of movement speed of affected hand

    Time frame: Day before intervention begins, compared to day after intervention ends (six days after intervention begins)

  2. Box and Blocks test

    Measure of movement speed of affected hand

    Time frame: Day before intervention begins, compared to day after intervention ends (six days after intervention begins)

07

Study locations

1 of 1 sites recruiting
  • Burke Medical Research Institute
    White Plains, New York 10605, United States
    • Kathleen M Friel, PhD · Contact · kaf3001@med.cornell.edu · 914-368-3116
    • Kathleen M Friel, PhD · Principal investigator
    • Andrew M Gordon, PhD · Sub investigator
    Recruiting
08

References and documents

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 35190424 ↗
  • Metelski 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 ↗

Individual participant data

Plan to share: Yes — The investigators will share IPD via the NIH Data Hub (DASH), which is sponsored by NICHD.

Time frame: Data will be available when study is complete, and remain in DASH indefinitely.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2019 (actual). Primary completion is estimated for Jun 2025, 66 months after the start.

Of 882 non-industry interventional studies with no phase under Cerebral Palsy, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 31. This study's planned 66 months is above that.

Counting every sponsor, half of 900 studies reached it within 12 months; a quarter within 5 and three quarters within 31.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 10, 2018
First posted
Jan 18, 2018
StartActual
Dec 1, 2019
Primary completionEst.
Jun 30, 2025
CompletionEst.
Aug 31, 2025
Last update
Jul 16, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03402854
Lead sponsor
Burke Medical Research Institute
Collaborators
University of Minnesota, Teachers College, Columbia University
Responsible party
Sponsor
First posted
Jan 18, 2018
Start date
Dec 1, 2019
Primary completion
Jun 30, 2025 (estimated)
Completion
Aug 31, 2025 (estimated)
Last update
Jul 16, 2024

Study contacts

Kathleen M Friel, PhD
Contact
kaf3001@med.cornell.edu
914-368-3116
Kathleen M Friel, PhD
principal investigator · Burke Medical Research Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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