tDCS + Bimanual Therapy for Cerebral Palsy

Overseen By Kathleen Friel, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Burke Medical Research Institute

Must not be taking: Spasticity medication

Disqualifiers: Seizures, Selective dorsal rhizotomy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 days

80 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{6 7 8 9 10}

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

I can bend my wrist 15 degrees.

I can pick up and hold light objects with my affected hand.

I have been diagnosed with congenital hemiplegic cerebral palsy.

Exclusion Criteria

I have undergone a selective dorsal rhizotomy procedure.

I have had seizures after turning 2 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either sham or active tDCS combined with 120 minutes of bimanual training daily

6 days

Daily visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Active tDCS
• Bimanual Training

Trial Overview

The study tests if active transcranial direct current stimulation (tDCS) combined with bimanual training improves hand function in these children compared to a sham tDCS plus bimanual training. Participants will be randomly assigned to one of these two groups.

How Is the Trial Designed?

Group I: Sham tDCS + bimanual training Experimental Treatment 1 Intervention

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.

Group II: Active tDCS + bimanual training Experimental Treatment 2 Interventions

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.

Active tDCS is already approved in United Kingdom, Brazil for the following indications:

Approved in United Kingdom as Transcranial Direct Current Stimulation for:

• Depression

Approved in Brazil as Transcranial Direct Current Stimulation for:

• Depression

Who Is Running the Clinical Trial?

Burke Medical Research Institute

Lead Sponsor

Trials

24

Recruited

1,500+

University of Minnesota

Collaborator

Trials

1,459

Recruited

1,623,000+

Teachers College, Columbia University

Collaborator

Trials

27

Recruited

6,100+

Published Research Related to This Trial

This study will evaluate the effectiveness of transcranial direct current stimulation (tDCS) combined with hand-arm bimanual intensive therapy (HABIT) in improving upper extremity function in 81 children aged 6-17 with unilateral spastic cerebral palsy (USCP).

The trial aims to determine if targeted tDCS enhances rehabilitation outcomes compared to sham stimulation, with primary outcomes including standardized tests of motor function and excitability, assessed before, immediately after, and 6 months post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Gordon, AM., Ferre, CL., Robert, MT., et al.[2022]

A single session of anodal transcranial direct current stimulation (tDCS) significantly improved unimanual gross motor dexterity in children and young adults with unilateral cerebral palsy (UCP), with effects lasting for at least 90 minutes after stimulation.

The study found no serious adverse effects from tDCS, indicating it is a safe intervention, although some mild and temporary side effects were reported, such as headache and tingling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Direct Current Stimulation (tDCS) in Unilateral Cerebral Palsy: A Pilot Study of Motor Effect. Inguaggiato, E., Bolognini, N., Fiori, S., et al.[2020]

In a study involving 8 children and young adults with unilateral cerebral palsy, cathodal transcranial direct current stimulation (tDCS) combined with bimanual training was safe, with no serious adverse events reported, and showed some participants achieving improvements in hand function.

Neurophysiological assessments indicated changes in cortical excitability, with 6 out of 6 participants showing decreased cortical silent period duration, suggesting that tDCS may influence brain activity, although the overall gains in hand function were inconsistent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Direct Current Stimulation (tDCS) Paired with Occupation-Centered Bimanual Training in Children with Unilateral Cerebral Palsy: A Preliminary Study. Rich, TL., Nemanich, S., Chen, M., et al.[2020]

In a study involving eight children with unilateral cerebral palsy, a combined intervention of bimanual therapy and transcranial direct current stimulation (tDCS) over 10 days led to significant improvements in a novel bimanual skill task, indicating enhanced motor learning.

The results showed that task performance improved during the intervention, with decreased variability in task execution for 6 out of 8 participants, suggesting that this rehabilitation approach may effectively support skill learning in children with UCP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bimanual Skill Learning after Transcranial Direct Current Stimulation in Children with Unilateral Cerebral Palsy: A Brief Report. Nemanich, ST., Rich, TL., Gordon, AM., et al.[2020]

Transcranial direct current stimulation (tDCS) is safe for preschool children with hemiplegic cerebral palsy, with no severe adverse events reported and only minor, transient discomfort experienced by a few participants.

A single session of anodal tDCS significantly improved manual dexterity in the hemiplegic hand, as measured by the Box and Block Test, with effects lasting for at least 90 minutes after stimulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and effects of transcranial direct current stimulation on hand function in preschool children with hemiplegic cerebral palsy: A pilot study. He, W., Huang, Y., He, L., et al.[2022]

In a study involving 30 children with spastic cerebral palsy, active transcranial direct current stimulation (tDCS) combined with dual task training resulted in significant improvements in functional mobility and performance measures one month after the intervention.

The study suggests that active tDCS can enhance the effectiveness of dual task training in children with spastic CP, indicating a potential therapeutic approach for improving motor and cognitive functions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Dual Task Training and Transcranial Direct Current Stimulation in Children with Spastic Cerebral Palsy: A Pilot Randomized Control Trial. Collange-Grecco, LA., Cosmo, C., Silva, ALS., et al.[2023]

The study involving 20 children and young adults with unilateral cerebral palsy found that transcranial direct current stimulation (tDCS) combined with constraint-induced movement therapy (CIMT) is safe, with no serious adverse events reported and only minor side effects like headache and itchiness.

While both groups showed significant improvements in hand function after treatment, there was no significant difference in outcomes between the active tDCS and sham groups, suggesting that tDCS may not enhance the effects of CIMT in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation and constraint-induced therapy in cerebral palsy: A randomized, blinded, sham-controlled clinical trial. Gillick, B., Rich, T., Nemanich, S., et al.[2019]

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