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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding transcranial direct current stimulation (tDCS), a technique using a small electrical current on the scalp, can enhance the effectiveness of constraint-induced movement therapy (CIMT). It targets children with hemiplegic cerebral palsy who struggle to use one arm and hand. Participants will receive either the real tDCS treatment combined with CIMT or a sham (placebo) version combined with CIMT. The study seeks children aged 5-17 who can follow instructions and have not recently undergone certain surgeries or treatments. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could improve therapy options for children with cerebral palsy.

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 prior data suggests that this method is safe for children with cerebral palsy?

Research has shown that using transcranial direct current stimulation (tDCS) with constraint-induced movement therapy (CIMT) is safe and feasible for children with cerebral palsy. Studies found that all children in the trials improved their hand function, regardless of their treatment group. No serious side effects occurred, indicating that participants tolerated the treatment well. This suggests that combining tDCS with CIMT could effectively help children with cerebral palsy enhance their movement abilities. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for cerebral palsy, which often focus on physical therapy and medication to manage symptoms, tDCS (transcranial direct current stimulation) combined with CIMT (constraint-induced movement therapy) offers a unique approach. This treatment uses a gentle electrical current to stimulate brain activity, potentially enhancing motor function and neuroplasticity more effectively. Researchers are excited because tDCS may directly influence the brain's ability to reorganize and improve, offering hope for more significant and quicker improvements in motor skills compared to traditional methods.

What evidence suggests that tDCS combined with CIMT might be an effective treatment for cerebral palsy?

This trial will compare the effects of combining transcranial direct current stimulation (tDCS) with constraint-induced movement therapy (CIMT) against a sham treatment. Research has shown that using tDCS with CIMT may improve movement in children with cerebral palsy. One study found that children who received tDCS along with motor training had better hand function. Other studies found that tDCS helped children walk faster. CIMT alone has already been shown to improve the use of the affected arm more effectively than standard therapy. Overall, these findings suggest that combining tDCS with CIMT could enhance therapy results for children with cerebral palsy. Participants in this trial will receive either active tDCS with CIMT or a sham tDCS with CIMT to evaluate the effectiveness of the combined treatment. ^{1 2 3 6 7}

Who Is on the Research Team?

Yanlong Song, PhD

Principal Investigator

University of Texas Southwestern Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5899638/

a randomized, blinded, sham-controlled clinical trial We investigated the safety, feasibility, and efficacy of transcranial direct current stimulation (tDCS) combined with constraint-induced movement therapy (CIMT)

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1090379817319256

Transcranial direct current stimulation and constraint ... tDCS and motor training in children with cerebral palsy is safe and feasible. · All children improved hand function, regardless of intervention group. · Children ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06239675

Cerebral pAlsy Motor Promotion With Transcranial Direct ... 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 ...

4. research.aota.org research.aota.org/ajot/article/77/3/7703205160/24141/Effectiveness-of-Constraint-Induced-Movement

Effectiveness of Constraint-Induced Movement Therapy for ... The results demonstrate that CIMT produces improved affected upper extremity function when compared with general rehabilitation. However, there ...

5. archives-pmr.org archives-pmr.org/article/S0003-9993(18)31446-1/abstract

Transcranial Direct Current Stimulation in Pediatric Motor ... Across 3 studies in children with cerebral palsy, tDCS significantly improved gait velocity (MD=. 23; 95% confidence interval [0.13-0.34]; P<. ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12087172/

Safety and effectiveness of non-invasive brain stimulation on ... Our findings support the use of NIBS as a safe and feasible tool for enhancing mobility in children with CP, demonstrating both immediate and sustained ...

7. ejpn-journal.com ejpn-journal.com/article/S1090-3798(17)31925-6/abstract

A randomized, blinded, sham-controlled clinical trial tDCS and motor training in children with cerebral palsy is safe and feasible. •. All children improved hand function, regardless of intervention group. •.