Using brain stimulation and therapy to improve hand function in children with hemiplegic cerebral palsy
tDCS and Bimanual Therapy for Children With Hemiplegic Cerebral Palsy
NA · Burke Medical Research Institute · NCT03402854
This study is testing whether a combination of brain stimulation and special hand training can help children with hemiplegic cerebral palsy use their hands better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 6 Years to 18 Years |
| Sex | All |
| Sponsor | Burke Medical Research Institute (other) |
| Locations | 1 site (White Plains, New York) |
| Trial ID | NCT03402854 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of transcranial direct current stimulation (tDCS) combined with bimanual training in enhancing hand function in children diagnosed with unilateral spastic cerebral palsy. Participants will be randomly assigned to receive either active tDCS with bimanual training or a sham treatment with bimanual training. The goal is to determine if the active stimulation can lead to better functional outcomes compared to the control group. The study focuses on children who can perform basic hand movements and follow instructions.
Who should consider this trial
Good fit: Ideal candidates for this study are children diagnosed with congenital hemiplegic cerebral palsy who can grasp light objects and extend their wrist.
Not a fit: Patients who have had seizures after age 2, recent spasticity medication, or surgeries on the affected arm may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve hand function in children with hemiplegic cerebral palsy, enhancing their daily activities and quality of life.
How similar studies have performed: Other studies utilizing tDCS in combination with rehabilitation therapies have shown promising results, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
White Plains, New York
- Burke Medical Research Institute — White Plains, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Kathleen M Friel, PhD — Burke Medical Research Institute
- Study coordinator: Kathleen M Friel, PhD
- Email: kaf3001@med.cornell.edu
- Phone: 914-368-3116
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cerebral Palsy, Hemiplegic Cerebral Palsy, Spastic Hemiplegic Cerebral Palsy, Spastic Hemiparesis, Spastic Hemiplegia, pediatric, children, non-invasive brain stimulation