tDCS for Autism

Recruiting at 1 trial location

Overseen by Peter Tsai, MD, PhD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Pregnancy, Brain implants, Pacemakers, others

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

The purpose of this research study is to investigate the effects of transcranial direct current stimulation (tDCS) on some of the challenges faced by children with Autism Spectrum Disorder (ASD).

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

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of this treatment for autism?

Research shows that transcranial direct current stimulation (tDCS), a non-invasive brain stimulation method, has shown promise in improving social, health, and behavioral issues in people with autism. Some studies found improvements in autism symptoms after using tDCS, although more standardized research is needed to confirm these findings. ^{1 2 3 4 5}

Is transcranial direct current stimulation (tDCS) safe for humans?

Transcranial direct current stimulation (tDCS) is generally considered safe and well-tolerated in humans, with no reports of serious or lasting harm in over 33,200 sessions across various populations, including potentially vulnerable groups like children and the elderly. ^{1 6 7 8 9}

How is the treatment tDCS different from other treatments for autism?

Transcranial Direct Current Stimulation (tDCS) is unique because it is a noninvasive treatment that uses a mild electrical current to stimulate specific areas of the brain, such as the prefrontal cortex, which may help improve symptoms like sociability and behavior in children with autism. Unlike medications, tDCS does not involve taking drugs and has shown potential therapeutic effects without reported side effects. ^{1 2 3 5 10}

Research Team

Peter Tsai, MD, PhD

Principal Investigator

UT Southwestern Medical Center

Eligibility Criteria

This trial is for children and young adults aged 5 to 21 with a clinical diagnosis of Autism Spectrum Disorder (ASD). It's not suitable for those who are pregnant, have brain implants or pacemakers, any metal implants, hearing or visual impairments, a history of brain injury, or known brain/skull abnormalities unrelated to ASD.

Inclusion Criteria

I am between 5 and 21 years old and have been diagnosed with autism.

Exclusion Criteria

Any biomedical or metal implants in any part of the body

I have no brain or skull issues unrelated to ASD.

History of brain injury

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Testing

Participants undergo baseline testing including psychometric battery, safety screening, and MRI/MEG

1 week

1 visit (in-person)

Treatment

Participants receive three weeks of sham stimulation and three weeks of 20-minute tDCS stimulation, with a 3-month washout period between sessions

6 weeks (plus 3-month washout)

Multiple visits (in-person)

Post-Testing

Participants undergo post-testing including psychometric battery and imaging

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Sham (Procedure)
• Transcranial Direct Current Stimulation (tDCS) (Behavioural Intervention)

Trial Overview The study is examining the impact of transcranial direct current stimulation (tDCS) on challenges associated with ASD. Participants will receive either the actual tDCS treatment or a sham (placebo-like) procedure to compare effects.

Participant Groups

Group I: transcranial direct current stimulation (tDCS), then sham stimulation Experimental Treatment 2 Interventions

Participants receives three weeks of 20-minute tDCS stimulation. After a washout period of 3 months, they then receive three weeks of sham stimulation

Group II: Sham stimulation, then transcranial direct current stimulation (tDCS) Experimental Treatment 2 Interventions

Participants receives three weeks of sham stimulation. After a washout period of 3 months, they then receive three weeks of 20-minute tDCS stimulation

Transcranial Direct Current Stimulation (tDCS) is already approved in Canada for the following indications:

Approved in Canada as Transcranial Direct Current Stimulation for:

• Depression
• Stroke rehabilitation
• Chronic pain management
• Research use for various neurological and psychiatric conditions including autism spectrum disorder

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Findings from Research

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]

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]

In a study involving 12 young adults with autism, inhibitory transcranial direct current stimulation (tDCS) led to a significant average reduction of 26.7% in abnormal behaviors as measured by the Aberrant Behavior Checklist after 10 sessions.

The most notable improvement was in hyperactivity and non-compliance, which decreased by 35.9%, and importantly, no adverse effects were reported, suggesting tDCS is a safe and feasible treatment option for behavioral abnormalities in autistic patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation for hyperactivity and noncompliance in autistic disorder. D'Urso, G., Bruzzese, D., Ferrucci, R., et al.[2019]

Transcranial direct current stimulation (tDCS) shows promise as a non-invasive treatment for Autism Spectrum Disorder (ASD), with 16 studies indicating improvements in social, health, and behavioral problems among participants.

The most common method involved anodal stimulation of the left dorsolateral prefrontal cortex, but the studies varied widely in methodology, highlighting the need for standardized protocols to better assess efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation in Autism Spectrum Disorder: A systematic review and meta-analysis. García-González, S., Lugo-Marín, J., Setien-Ramos, I., 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]

A systematic review of 64 studies involving 2262 participants found that transcranial direct current stimulation (tDCS) has a low dropout rate (6% for active and 7.2% for sham), indicating good acceptability among participants.

Despite the low dropout rates, many studies inadequately reported adverse events (AEs), highlighting a need for improved guidelines to standardize AE reporting in tDCS research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review on the Acceptability and Tolerability of Transcranial Direct Current Stimulation Treatment in Neuropsychiatry Trials. Aparício, LVM., Guarienti, F., Razza, LB., et al.[2018]

Transcranial Direct Current Stimulation (tDCS) is generally considered safe, but there are concerns that it could lead to significant negative effects in healthy individuals.

The scientific community needs to be alerted about the potential risks of tDCS, emphasizing the importance of protecting healthy volunteers from possible harm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of transcranial direct current stimulation in healthy participants. Boccard-Binet, S., Sen, A.[2021]

Transcranial Direct Current Stimulation (tDCS) has been shown to be safe, with no reports of Serious Adverse Effects or irreversible injuries across over 33,200 sessions involving more than 1,000 subjects, including vulnerable populations.

Safety assessments indicate that the current densities used in conventional tDCS (≤4 milliamperes) are significantly lower than those that could potentially cause brain injury, suggesting that tDCS protocols are well within safe limits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Bikson, M., Grossman, P., Thomas, C., et al.[2022]

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]

References

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

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

2. 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]

3. England pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation for hyperactivity and noncompliance in autistic disorder. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation in Autism Spectrum Disorder: A systematic review and meta-analysis. [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

A Systematic Review on the Acceptability and Tolerability of Transcranial Direct Current Stimulation Treatment in Neuropsychiatry Trials. [2018]

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

Safety of transcranial direct current stimulation in healthy participants. [2021]

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

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. [2022]

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

Tolerability and blinding of 4x1 high-definition transcranial direct current stimulation (HD-tDCS) at two and three milliamps. [2020]

10. 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]