80 Participants Needed

tDCS + Bimanual Therapy for Cerebral Palsy

Kathleen Friel, PhD profile photo
Overseen ByKathleen Friel, PhD
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Burke Medical Research Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of the treatment tDCS + Bimanual Therapy for Cerebral Palsy?

Research suggests that combining transcranial direct current stimulation (tDCS) with bimanual therapy may improve hand function in children with cerebral palsy, although the specific effects of tDCS alone are not significant. Studies indicate that children with certain brain connectivity patterns may benefit more from this combined approach.12345

Is tDCS combined with bimanual therapy safe for people with cerebral palsy?

Research shows that transcranial direct current stimulation (tDCS) is generally safe for children with cerebral palsy, with only mild and temporary side effects like headaches and skin irritation reported. No serious adverse events were observed in studies involving tDCS, whether used alone or combined with therapies like bimanual training.12367

How does the tDCS + Bimanual Therapy treatment for cerebral palsy differ from other treatments?

This treatment combines transcranial direct current stimulation (tDCS), a non-invasive brain stimulation technique, with intensive bimanual therapy to enhance motor function in children with cerebral palsy. It is unique because it targets the brain hemisphere connected to the impaired muscles, potentially improving the effectiveness of physical rehabilitation compared to traditional therapies.12345

What is the purpose of this trial?

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.

Research Team

Kathleen M. Friel, Ph.D. | Burke ...

Kathleen Friel, PhD

Principal Investigator

Burke Medical Research Institute

Eligibility Criteria

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.
See 2 more

Exclusion Criteria

I have undergone a selective dorsal rhizotomy procedure.
I have had seizures after turning 2 years old.

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Sham tDCS + bimanual trainingExperimental Treatment1 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 trainingExperimental Treatment2 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:

๐Ÿ‡ฌ๐Ÿ‡ง
Approved in United Kingdom as Transcranial Direct Current Stimulation for:
  • Depression
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Approved in Brazil as Transcranial Direct Current Stimulation for:
  • Depression

Find a Clinic Near You

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+

Findings from Research

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.
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]
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.
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.
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]

References

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. [2022]
Effects of Dual Task Training and Transcranial Direct Current Stimulation in Children with Spastic Cerebral Palsy: A Pilot Randomized Control Trial. [2023]
Transcranial direct current stimulation and constraint-induced therapy in cerebral palsy: A randomized, blinded, sham-controlled clinical trial. [2019]
Bimanual Skill Learning after Transcranial Direct Current Stimulation in Children with Unilateral Cerebral Palsy: A Brief Report. [2020]
Transcranial Direct Current Stimulation (tDCS) Paired with Occupation-Centered Bimanual Training in Children with Unilateral Cerebral Palsy: A Preliminary Study. [2020]
Safety and effects of transcranial direct current stimulation on hand function in preschool children with hemiplegic cerebral palsy: A pilot study. [2022]
Transcranial Direct Current Stimulation (tDCS) in Unilateral Cerebral Palsy: A Pilot Study of Motor Effect. [2020]
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