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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if transcranial direct current stimulation (tDCS) can benefit children with Autism Spectrum Disorder (ASD). The focus is on enhancing social communication and self-regulation, common challenges for those with ASD. Participants will receive either the active tDCS treatment at home or a placebo version (a treatment that appears the same but lacks active effects) for three weeks. This trial suits children with ASD who struggle with social skills or self-control and do not have a history of seizures or metal implants. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of participants.

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 prior data suggests that at-home tDCS is safe for children and youth with Autism Spectrum Disorder?

Research shows that using transcranial direct current stimulation (tDCS) at home is generally safe and well-tolerated. Previous studies found that tDCS is a non-invasive method safely used in adults. Researchers are exploring its potential to help with social communication and self-control, especially in young people with Autism Spectrum Disorder (ASD).

The studies indicate that this method usually does not cause serious side effects. Some people might feel minor discomfort, like tingling or itching on the scalp, but these effects are typically mild and temporary. Since this treatment is being tested in a Phase 2 trial, it has already passed initial safety tests in humans. This phase aims to learn more about how well people handle it and how it might affect the intended results. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Autism?

Researchers are excited about at-home tDCS for autism because it offers a unique, non-invasive way to potentially enhance brain function. Unlike traditional therapies like behavioral interventions or medication, tDCS involves applying a mild electrical current to the scalp to modulate brain activity, which can be done comfortably at home. This method could provide a more accessible and flexible treatment option, especially for individuals who have difficulty attending in-person therapy sessions. Additionally, the sham arm of the study allows researchers to effectively measure the real impact of tDCS by comparing it to a placebo-like experience, ensuring that any observed benefits are due to the treatment itself.

What evidence suggests that At-home tDCS is effective for improving social communication and self-regulation in youth with Autism?

Research has shown that using a device at home called transcranial direct current stimulation (tDCS) can help children with Autism Spectrum Disorder (ASD) improve their social skills and better manage their emotions. In this trial, participants will receive either active tDCS or sham tDCS, which serves as a placebo. Studies found that children using active tDCS showed noticeable improvements compared to those not using the device. This treatment is safe and simple to use at home, offering a convenient option for families. Additionally, significant reductions in autism symptoms occurred after both short-term and long-term use. These findings suggest that tDCS could effectively help children with ASD enhance their social and cognitive skills. ^{3 4 5 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

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This research is being done to determine whether transcranial direct current stimulation (tDCS) can improve certain mental abilities.

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withpower.com/trial/phase-2-autistic-disorder-9-2023-ddf58

At-home tDCS for Autism

Transcranial direct current stimulation (tDCS) significantly reduced autism severity in children with autism spectrum disorder (ASD) after both 5 and 20 ...

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Systematic Review on the Safety and Tolerability of ...

Background: Transcranial direct current stimulation (tDCS) is a safe, tolerable, and acceptable technique in adults.