Transcranial Direct Current Stimulation for Autism

Overseen By Catherine Stoodley, D.Phil.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: American University

Must not be taking: Psychotropic medication

Disqualifiers: Neurological condition, Brain injury, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1-2 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing whether brain stimulation can improve social and thinking skills in young adults with autism. The treatment involves using electrical or magnetic stimulation on specific parts of the brain. Researchers hope this will help people with autism communicate better and think more flexibly. The new method aims to enhance cognitive, motor, and social communication abilities.

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

The trial does not specify if you need to stop taking your current medications, but it does exclude neurotypical adults who are on psychotropic medication. If you are taking such medications, you may not be eligible to participate.

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

Transcranial direct current stimulation (tDCS) is generally considered safe for humans, with studies showing no serious or lasting side effects across many sessions and participants, including children and other vulnerable groups. However, some reports suggest it could potentially cause significant issues, so caution is advised. ^{1 2 3 4 5}

How does transcranial direct current stimulation (tDCS) differ from other treatments for autism?

Transcranial direct current stimulation (tDCS) is unique because it is a noninvasive method that uses electrical currents to stimulate specific brain areas, potentially improving sociability, behavior, and physical conditions in children with autism. Unlike medications, tDCS directly targets brain function and has shown promising results without reported side effects. ^{2 5 6 7 8}

What data supports the effectiveness of the treatment Transcranial Direct Current Stimulation for Autism?

Research shows that transcranial direct current stimulation (tDCS) can help improve sociability, behavior, health, and physical conditions in children with autism spectrum disorder (ASD) without side effects. Studies found significant improvements in autism treatment evaluation scores after tDCS sessions, suggesting it may be a beneficial treatment for reducing symptoms of ASD. ^{2 5 7 8 9}

Who Is on the Research Team?

Catherine Stoodley, D.Phil.

Principal Investigator

American University

Are You a Good Fit for This Trial?

This trial is for right-handed, English-speaking adults aged 18-35 with or without autism. Participants must be able to consent and attend all sessions, have no metal in their body, no history of seizures or claustrophobia, and a cognitive function score ≥ 85. Those with autism need a confirmed diagnosis.

Inclusion Criteria

All participants must not be pregnant

Additional inclusion criteria for adults with autism: Either have a prior research-reliable diagnosis of autism spectrum disorder (ASD) or meet DSM-5 criteria for ASD confirmed with ADOS-2 via research-reliable clinical assessment

All participants must be right-handed

Exclusion Criteria

Neurotypical adults

Pregnant participants

I do not have metal implants, pacemakers, a history of seizures, or severe claustrophobia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive excitatory, inhibitory, or sham neuromodulation targeting the cerebellum

1-2 weeks

Multiple sessions for neuromodulation and fMRI

Follow-up

Participants are monitored for changes in social and cognitive functions post-neuromodulation

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transcranial direct current stimulation

Trial Overview The study tests the effects of transcranial direct current stimulation (tDCS) on social and executive functions in young adults with and without autism by applying mild electrical currents to the cerebellum during MRI scans.

How Is the Trial Designed?

Group I: Right cerebellum Experimental Treatment 1 Intervention

Participants (neurotypical, autistic) in this arm will receive tDCS targeting the right posterolateral cerebellum (lobule VII). All participants will receive anodal, cathodal and sham tDCS.

Group II: Posterior vermis Experimental Treatment 1 Intervention

Participants (neurotypical, autistic) in this arm will receive tDCS targeting the posterior cerebellar vermis. All participants will receive anodal, cathodal and sham tDCS.

Transcranial direct current stimulation is already approved in United States, European Union, Canada for the following indications:

Approved in United States as tDCS for:

• Depression
• Chronic pain
• Stroke rehabilitation
• Traumatic brain injury rehabilitation

Approved in European Union as tDCS for:

• Major depressive disorder
• Chronic pain
• Stroke rehabilitation
• Traumatic brain injury rehabilitation

Approved in Canada as tDCS for:

• Depression
• Chronic pain
• Stroke rehabilitation
• Traumatic brain injury rehabilitation

Who Is Running the Clinical Trial?

American University

Lead Sponsor

Trials

22

Recruited

5,600+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

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 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]

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 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 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) 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]

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) 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]

Transcranial direct current stimulation (tDCS) showed significant changes in EEG microstates and Autism Behavior Checklist (ABC) scores in children with autism spectrum disorder (ASD), suggesting it may positively affect neurodevelopmental functions.

In contrast, the sham stimulation group did not exhibit any changes in EEG microstates or ABC scores, highlighting the potential efficacy of tDCS as a treatment for ASD compared to a placebo effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Direct Current Stimulation Modulates EEG Microstates in Low-Functioning Autism: A Pilot Study. Kang, J., Fan, X., Zhong, Y., et al.[2023]

Citations

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. Netherlands pubmed.ncbi.nlm.nih.gov

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

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. England pubmed.ncbi.nlm.nih.gov

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

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

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

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

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

7. 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]

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

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

9. Switzerland pubmed.ncbi.nlm.nih.gov

Transcranial Direct Current Stimulation Modulates EEG Microstates in Low-Functioning Autism: A Pilot Study. [2023]