tDCS + Bimanual Therapy for Cerebral Palsy
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new method to help children with unilateral spastic cerebral palsy (USCP) improve hand function. It combines two approaches: transcranial direct current stimulation (tDCS) and bimanual training, where children use both hands to play games. Some participants will use a real tDCS device, while others will use a non-stimulating version to assess the treatment's effectiveness. The trial seeks children with congenital hemiplegic cerebral palsy who can lift light objects and move their affected hand. As an unphased trial, it offers a unique opportunity for children to potentially benefit from innovative therapies while contributing to important research.
Will I have to stop taking my current medications?
The trial requires that participants have not taken spasticity medication within 6 months before the study. If you are currently on such medication, you would need to stop it to be eligible.
What prior data suggests that transcranial direct current stimulation combined with bimanual training is safe for children with unilateral spastic cerebral palsy?
Research has shown that transcranial direct current stimulation (tDCS) is generally safe for children with cerebral palsy. Studies have found that tDCS does not cause swelling or harmful changes in the brain. In one study, children safely used tDCS at home with their caregivers. Another study on preschool children with cerebral palsy found that tDCS was well-tolerated and did not cause any major side effects.
Bimanual training, which involves using both hands together, has also been widely studied. Research indicates that it is safe and effective for improving hand coordination in children with cerebral palsy.
Overall, both tDCS and bimanual training appear to be safe options for children with cerebral palsy, with no serious safety concerns reported in recent studies.12345Why are researchers excited about this trial?
Researchers are excited about the tDCS + Bimanual Therapy for cerebral palsy because it offers a unique approach by combining brain stimulation with physical therapy. Unlike traditional treatments that focus primarily on physical exercises and medication, this method uses transcranial direct current stimulation (tDCS) to potentially enhance brain plasticity and improve motor function. The active tDCS is delivered through sponges placed on the scalp, adding a new dimension to therapy by directly influencing neural pathways. This innovative combination might lead to more effective and quicker improvements in motor skills for individuals with cerebral palsy than current treatment options alone.
What evidence suggests that this trial's treatments could be effective for cerebral palsy?
Studies have shown that active tDCS (a type of brain stimulation) can improve movement in children with cerebral palsy, demonstrating moderate success with a statistical measure of 0.53. In this trial, one group of participants will receive active tDCS combined with bimanual training, which involves exercises using both hands. Research indicates that this combination is safe and practical, enhancing movement and hand use. Another group will participate in bimanual training alone, which also improves hand coordination and self-care skills. Combining both methods might enhance the benefits, leading to even greater improvements in hand function for children with unilateral spastic cerebral palsy.678910
Who Is on the Research Team?
Kathleen Friel, PhD
Principal Investigator
Burke Medical Research Institute
Are You a Good Fit for This Trial?
This trial is for children with unilateral spastic cerebral palsy who can follow instructions, lift and grasp light objects with the affected hand, and extend their wrist at least 15 degrees. Parents must consent. Children who've had selective dorsal rhizotomy or seizures after age 2 are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either sham or active tDCS combined with 120 minutes of bimanual training daily
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Active tDCS
- Bimanual Training
Active tDCS is already approved in United Kingdom, Brazil for the following indications:
- Depression
- Depression
Find a Clinic Near You
Who Is Running the Clinical Trial?
Burke Medical Research Institute
Lead Sponsor
University of Minnesota
Collaborator
Teachers College, Columbia University
Collaborator