80 Participants Needed

Transcranial Direct Current Stimulation for Autism

CS
Overseen ByCatherine Stoodley, D.Phil.
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: American University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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.12345

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.25678

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.25789

Who Is on the Research Team?

CS

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 β‰₯ 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
See 5 more

Exclusion Criteria

Neurotypical adults
Pregnant participants
I do not have metal implants, pacemakers, a history of seizures, or severe claustrophobia.
See 8 more

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?
2Treatment groups
Experimental Treatment
Group I: Right cerebellumExperimental Treatment1 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 vermisExperimental Treatment1 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:

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Approved in United States as tDCS for:
  • Depression
  • Chronic pain
  • Stroke rehabilitation
  • Traumatic brain injury rehabilitation
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Approved in European Union as tDCS for:
  • Major depressive disorder
  • Chronic pain
  • Stroke rehabilitation
  • Traumatic brain injury rehabilitation
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Approved in Canada as tDCS for:
  • Depression
  • Chronic pain
  • Stroke rehabilitation
  • Traumatic brain injury rehabilitation

Find a Clinic Near You

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.
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.
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.
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]

Citations

Long-term effects of transcranial direct current stimulation in the treatment of autism spectrum disorder: A randomized controlled trial. [2023]
Effect of anodal transcranial direct current stimulation on autism: a randomized double-blind crossover trial. [2018]
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]
Transcranial direct current stimulation in children with autism spectrum disorder: a systematic scoping review. [2019]
Transcranial direct current stimulation for hyperactivity and noncompliance in autistic disorder. [2019]
Safety of transcranial direct current stimulation in healthy participants. [2021]
A Systematic Review on the Acceptability and Tolerability of Transcranial Direct Current Stimulation Treatment in Neuropsychiatry Trials. [2018]
Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. [2022]
Transcranial Direct Current Stimulation Modulates EEG Microstates in Low-Functioning Autism: A Pilot Study. [2023]
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