What is the mechanism of action of this treatment?

Common treatments for Autism Spectrum Disorder (ASD) include behavioral and educational interventions that aim to improve communication and social skills. Augmentative communication strategies, such as the Picture Exchange Communication System (PECS), help nonverbal individuals or those with limited language skills to communicate using pictures, thereby reducing frustration and promoting symbolic communication. Social skills instruction targets core social deficits in ASD, with evidence suggesting short-term improvements in social competence and friendship quality. Neuromodulation therapies, like those being studied for cerebellar modulation, aim to regulate neural activity to enhance social and executive functions, potentially offering new avenues for addressing the complex neural underpinnings of ASD.

What side effects are associated with this type of intervention?

Neuromodulation techniques such as repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS) are being studied for their potential benefits in Autism Spectrum Disorder (ASD). Common side effects of rTMS include headaches, scalp discomfort at the stimulation site, and, less frequently, lightheadedness and tingling. Serious side effects are rare but can include seizures. For tDCS, side effects are generally mild and may include skin irritation at the electrode sites, a tingling sensation, and headaches. Both techniques are considered relatively safe, but long-term safety data are still limited.

What prior FDA approvals exist?

Currently, the FDA has approved two medications for the treatment of irritability associated with Autism Spectrum Disorder (ASD): risperidone and aripiprazole. These antipsychotic drugs help manage symptoms such as aggression, self-injury, and severe tantrums. While neuromodulation techniques like transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS) are being studied for their potential to improve social and executive functions in individuals with ASD, they have not yet received FDA approval for this indication.

What other types of research exist?

Promising, novel alternatives to neuromodulation for Autism Spectrum Disorder patients include: 1) Behavioral interventions such as Applied Behavior Analysis (ABA) and Early Start Denver Model (ESDM), which focus on improving social and communication skills. 2) Pharmacological treatments targeting core symptoms of ASD, including medications like aripiprazole and risperidone for irritability and new drugs under investigation for social and cognitive deficits. 3) Digital therapeutics and assistive technologies, including apps and virtual reality programs designed to enhance social skills and executive functioning. 4) Genetic and molecular therapies, such as gene editing and targeted molecular treatments, which are in early stages of research but hold potential for addressing underlying biological mechanisms of ASD.

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Neuromodulation

Transcranial Direct Current Stimulation for Autism

N/A

Recruiting

Led By Catherine Stoodley, D.Phil.

Research Sponsored by American University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

All participants must be aged 18-35

All participants must have NIH Toolbox age-adjusted Cognitive Function Composite standard score ≥ 85

Must not have

Participants with contraindications for MRI or neuromodulation with tDCS (e.g. metal in body, pacemaker or other implanted device, history of seizure, claustrophobia)

Participants with current or prior history of neurological or neurodevelopmental condition or brain injury

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 45min post-tdcs

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects from tDCS may include temporary discomfort at the stimulation site like itching or tingling, headache, fatigue, nausea or irritability. Serious side effects are rare but can include seizures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 35 years old.

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My cognitive function score is 85 or higher.

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I can attend all required study sessions.

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I am a native English speaker.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have a history of brain conditions or injuries.

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I am an adult with autism and I am either younger than 18 or older than 35.

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I am younger than 18 or older than 35.

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I am an adult with autism and my cognitive function score is below 85.

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My cognitive function score is below 85.

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I am taking medication for my mental health.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 45min post-tdcs

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 45min post-tdcs

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 45min post-tdcs for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Functional MRI data

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transcranial direct current stimulation

2012

Completed Phase 3

~650

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Autism Spectrum Disorder (ASD) include behavioral and educational interventions that aim to improve communication and social skills. Augmentative communication strategies, such as the Picture Exchange Communication System (PECS), help nonverbal individuals or those with limited language skills to communicate using pictures, thereby reducing frustration and promoting symbolic communication. Social skills instruction targets core social deficits in ASD, with evidence suggesting short-term improvements in social competence and friendship quality. Neuromodulation therapies, like those being studied for cerebellar modulation, aim to regulate neural activity to enhance social and executive functions, potentially offering new avenues for addressing the complex neural underpinnings of ASD.

Nucleus accumbens: a systematic review of neural circuitry and clinical studies in healthy and pathological states.Comparative efficacy and acceptability of neuromodulation procedures in the treatment of treatment-resistant depression: a network meta-analysis of randomized controlled trials.Neuromodulation in psychiatric disorders.