tDCS + CIMT for Cerebral Palsy

Overseen By Yanlong Song, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Must not be taking: Psychoactive, Myorelaxant

Disqualifiers: Brain surgery, Genetic disorders, others

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

Compensation: Varies

Number of Visits: 19

60 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

Yes, you will need to stop taking any psychoactive or muscle-relaxing medications during the study.

What data supports the effectiveness of the treatment tDCS for cerebral palsy?

Research shows that transcranial direct current stimulation (tDCS) is safe and can improve hand function in children with cerebral palsy, especially when combined with other therapies like constraint-induced movement therapy (CIMT). However, the specific effect of tDCS alone on improving motor function is not yet clear, and more studies are needed to determine the best way to use it. ^{1 2 3 4 5}

Is transcranial direct current stimulation (tDCS) safe for people with cerebral palsy?

Research shows that tDCS is generally safe for people with cerebral palsy, with no serious side effects reported. Some minor side effects like headaches and skin irritation may occur, but they are usually mild and temporary. ^{1 2 3 6 7}

How is the treatment tDCS + CIMT for cerebral palsy different from other treatments?

The treatment combines transcranial direct current stimulation (tDCS), which uses a mild electrical current to stimulate the brain, with constraint-induced movement therapy (CIMT), which encourages the use of the affected limb by restricting the unaffected one. This combination aims to enhance motor function by potentially reorganizing brain pathways, making it a novel approach compared to traditional therapies that do not use electrical brain stimulation. ^{1 2 3 4 5}

What is the purpose of this trial?

This study aims to test if transcranial direct current stimulation (tDCS) can be applied to boost the efficacy of constraint-induced movement therapy (CIMT) in children with HCP and examine brain mechanisms related to individual outcomes.

Research Team

Yanlong Song, PhD

Principal Investigator

University of Texas Southwestern Medical Center

Eligibility Criteria

This trial is for children with Hemiplegic Cerebral Palsy (HCP), a condition affecting one side of the body. Participants should be able to follow instructions and attend multiple therapy sessions. Children with metal in their head, skin conditions on the scalp, seizures, or those who can't tolerate having their stronger arm restrained are excluded.

Inclusion Criteria

I can understand and follow study instructions.

I am between 5 and 17 years old.

I have been diagnosed with hemiplegic cerebral palsy.

Exclusion Criteria

I had surgery on my arm or shoulder less than a year ago.

I am older than 17 and younger than 5 years old.

I have had brain or nerve surgery, or I have a genetic or other neurological disorder.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Intervention

Participants receive either anodal tDCS and CIMT or sham tDCS and CIMT for 2 hours, five days a week

3 weeks

15 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

3 visits (in-person)

Treatment Details

Interventions

• tDCS

Trial Overview The study is testing whether tDCS (a non-invasive brain stimulation technique) can improve how well constraint-induced movement therapy (CIMT) works for improving motor skills in kids with HCP. Some will receive real tDCS while others get a sham treatment as part of the research design.

Participant Groups

Group I: tDCS+CIMT Experimental Treatment 2 Interventions

Participants will receive concurrent anodal tDCS (20 minutes, 1mA\~2mA) and CIMT (2 hours) five days a week for three weeks in a row.

Group II: sham+CIMT Placebo Group 2 Interventions

Participants will receive concurrent sham tDCS and CIMT (2 hours) five days a week for three weeks in a row.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Children's Health

Collaborator

Trials

8

Recruited

460+

Findings from Research

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]

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]

References

1. England 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. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation and constraint-induced therapy in cerebral palsy: A randomized, blinded, sham-controlled clinical trial. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Transcranial Direct-Current Stimulation on Motor Function in Pediatric Cerebral Palsy: A Systematic Review. [2019]

4. Thailand pubmed.ncbi.nlm.nih.gov

Reduction of spasticity in cerebral palsy by anodal transcranial direct current stimulation. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Anodal Contralesional tDCS Enhances CST Excitability Bilaterally in an Adolescent with Hemiparetic Cerebral Palsy: A Brief Report. [2023]

6. Switzerland 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. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Remotely monitored transcranial direct current stimulation in pediatric cerebral palsy: open label trial protocol. [2023]