At-home tDCS for Autism

Overseen By Deryk Beal, PhD, Reg. CASLPO, CCC-SLP

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Holland Bloorview Kids Rehabilitation Hospital

Disqualifiers: Seizures, Metal implants, Epilepsy, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 21

Duration: 3 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

Transcranial direct current stimulation (tDCS) is a form of non-invasive brain stimulation that can be delivered in a home setting. It is a safe and tolerable intervention that has shown promise for improving positive social communication and self-regulation in youth with Autism Spectrum Disorder (ASD). Children and youth with ASD will be randomized to At-home tDCS or sham control stimulation for 3 weeks. We will measure the effect of At-home tDCS on the brain mechanisms and clinical measures of social communication and self-regulation..

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment At-home tDCS for Autism?

Research shows that transcranial direct current stimulation (tDCS) can help improve social skills, behavior, and overall health in children with autism. Studies found significant improvements in these areas after tDCS treatment compared to a placebo, with no reported side effects. ^{1 2 3 4 5}

How is at-home tDCS treatment for autism different from other treatments?

At-home tDCS (transcranial direct current stimulation) is unique because it allows for noninvasive brain stimulation to be administered at home under remote supervision, making it more accessible and convenient compared to traditional clinic-based therapies. This treatment involves applying a mild electrical current to the scalp, which may help reduce autism symptoms over time with repeated sessions. ^{1 2 4 5 6}

Eligibility Criteria

This trial is for children with Autism Spectrum Disorder (ASD) who have difficulties with self-regulation or social communication. They must be able to participate in at-home brain stimulation treatments.

Inclusion Criteria

My child has autism with difficulties in self-regulation or social communication.

I am able to undergo brain stimulation therapy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either active tDCS or sham control stimulation for 3 weeks

3 weeks

15 sessions (home-based)

Follow-up

Participants are monitored for safety and effectiveness after treatment

15 weeks

Assessments at 6 weeks and 18 weeks

Treatment Details

Interventions

• At-home tDCS
• Sham at-home tDCS

Trial Overview The study tests if a home-based brain stimulation technique, called tDCS, can help improve social communication and behavior in kids with ASD. Participants are randomly assigned to either the real tDCS or a sham (fake) treatment for three weeks.

Participant Groups

Group I: tDCS Experimental Treatment 1 Intervention

active tDCS

Group II: Sham Placebo Group 1 Intervention

sham tDCS

Who Is Running the Clinical Trial?

Holland Bloorview Kids Rehabilitation Hospital

Lead Sponsor

Trials

69

Recruited

14,100+

Findings from Research

Transcranial direct current stimulation (tDCS) significantly reduced autism severity in children with autism spectrum disorder (ASD) after both 5 and 20 sessions compared to a control group receiving sham treatment, with effects lasting for at least 12 months.

There was no significant difference in efficacy between the 5-session and 20-session tDCS groups, suggesting that fewer sessions may be just as effective as more, while sham tDCS also showed some benefits starting at 6 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term effects of transcranial direct current stimulation in the treatment of autism spectrum disorder: A randomized controlled trial. Auvichayapat, P., Intayot, K., Udomchat, C., et al.[2023]

A systematic review of five studies on transcranial direct current stimulation (tDCS) in children with autism spectrum disorder (ASD) showed positive effects on reducing symptom severity, although the studies varied widely in design and sample size (1 to 20 participants).

Despite the encouraging preliminary evidence suggesting potential benefits, the overall quality of the studies is low, indicating a need for more rigorous randomized controlled trials to better understand the efficacy of tDCS in treating ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation in children with autism spectrum disorder: a systematic scoping review. Osório, AAC., Brunoni, AR.[2019]

Bilateral anodal transcranial direct current stimulation (tDCS) applied to the prefrontal and motor areas showed significant therapeutic effects in children with autism spectrum disorder (ASD), leading to improvements in sociability and behavioral health, as indicated by decreased scores on the autism treatment evaluation checklist (ATEC).

The study involved 50 children with ASD who underwent 10 sessions of tDCS, with no reported side effects, suggesting that tDCS is a safe and noninvasive method for potentially enhancing clinical outcomes in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic Effects of Bilateral Anodal Transcranial Direct Current Stimulation on Prefrontal and Motor Cortical Areas in Children with Autism Spectrum Disorders: A Pilot Study. Hadoush, H., Nazzal, M., Almasri, NA., et al.[2021]

A home-based protocol for transcranial direct current stimulation (tDCS) called remotely supervised (RS)-tDCS was found to be tolerable for participants, with no serious adverse events reported across 6779 sessions in six clinical trials involving 308 participants.

Common mild side effects included tingling, itching, and warmth at the electrode site, but these were similar in both active and sham tDCS conditions, indicating that RS-tDCS is feasible for use in clinical trials without significant discomfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tolerability and feasibility of at-home remotely supervised transcranial direct current stimulation (RS-tDCS): Single-center evidence from 6,779 sessions. Pilloni, G., Vogel-Eyny, A., Lustberg, M., et al.[2022]

In a study involving 20 patients with autism, anodal transcranial direct current stimulation (tDCS) significantly reduced scores on the Childhood Autism Rating Scale (CARS) and the Autism Treatment Evaluation Checklist (ATEC), indicating improvements in autism symptoms.

Additionally, the Children's Global Assessment Scale (CGAS) showed a significant increase at 7 days post-treatment, suggesting that tDCS may enhance overall functioning in individuals with autism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of anodal transcranial direct current stimulation on autism: a randomized double-blind crossover trial. Amatachaya, A., Auvichayapat, N., Patjanasoontorn, N., et al.[2018]

Transcranial direct current stimulation (tDCS) is a promising noninvasive treatment that can improve symptoms of various nervous system conditions, and its effects are enhanced with daily use, making at-home application an attractive option.

The study provides comprehensive guidelines for safely and effectively using tDCS at home, which can improve patient access and compliance, especially for those with mobility challenges or living in remote areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supervised transcranial direct current stimulation (tDCS) at home: A guide for clinical research and practice. Charvet, LE., Shaw, MT., Bikson, M., et al.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Long-term effects of transcranial direct current stimulation in the treatment of autism spectrum disorder: A randomized controlled trial. [2023]

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

Transcranial direct current stimulation in children with autism spectrum disorder: a systematic scoping review. [2019]

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

Therapeutic Effects of Bilateral Anodal Transcranial Direct Current Stimulation on Prefrontal and Motor Cortical Areas in Children with Autism Spectrum Disorders: A Pilot Study. [2021]

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

Tolerability and feasibility of at-home remotely supervised transcranial direct current stimulation (RS-tDCS): Single-center evidence from 6,779 sessions. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Effect of anodal transcranial direct current stimulation on autism: a randomized double-blind crossover trial. [2018]

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

Supervised transcranial direct current stimulation (tDCS) at home: A guide for clinical research and practice. [2020]