NCT03402854 · Burke Medical Research Institute
tDCS and Bimanual Therapy for Children With Hemiplegic Cerebral Palsy
What this study is about
The goal of this study is to test the effectiveness 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 randomly assigned to receive either sham (not stimulating) tDCS plus bimanual training, or active (stimulating) tDCS plus bimanual training.
View original scientific description
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.
Interventions
DEVICE
active transcranial direct current stimulation
Participants will receive 20 min of tDCS over the scalp during the first 20 min of bimanual training.
BEHAVIORAL
bimanual training
Participants will engage in movements that use both hands, by playing with toys and games.
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Seizures after age 2 years
- Spasticity medication within 6 months before study
- Selective dorsal rhizotomy
- Surgery in affected upper extremity within year before study
Where
- White Plains, New York
Collaborators
University of Minnesota, Teachers College, Columbia University
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 16, 2024 · Source of record for eligibility and locations