What side effects are associated with this type of intervention?

Transcranial Direct Current Stimulation (tDCS) is generally considered safe, with common side effects including mild skin irritation at the electrode site, tingling sensations, and headaches. Other common treatments for Autism Spectrum Disorder, such as behavioral therapies, typically have minimal physical side effects but can be emotionally taxing. Medications used to manage symptoms, like antipsychotics and stimulants, can have side effects such as weight gain, drowsiness, and gastrointestinal issues.

What prior FDA approvals exist?

The FDA has approved two medications for the treatment of irritability associated with Autism Spectrum Disorder: risperidone and aripiprazole. These medications are antipsychotics that help manage symptoms such as aggression, self-injury, and severe tantrums. While these drugs do not directly modulate neuronal activity in the cerebellum like tDCS, they do affect neurotransmitter systems in the brain. Currently, there are no FDA-approved treatments specifically targeting neuronal modulation in the cerebellum for ASD.

What other types of research exist?

Promising, novel alternatives to tDCS for Autism Spectrum Disorder patients include: 1) Deep Brain Stimulation (DBS), which is being investigated for its effects on neurological conditions and has shown some efficacy in related disorders like OCD. 2) Repetitive Transcranial Magnetic Stimulation (rTMS), which has been studied for various psychiatric conditions and may offer benefits for ASD symptoms. Both techniques are still under investigation and should be considered in consultation with a healthcare provider.

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Noninvasive Brain Stimulation

tDCS for Autism

N/A

Recruiting

Led By Peter Tsai, MD, PhD

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

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

Must have

4-17 years old

Diagnosed with ASD and ADOS-2

Must not have

Known brain abnormalities not associated with ASD

Hearing or visual impairments

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-intervention up to one month

Summary

This trial is testing a treatment called tDCS, which uses a small electrical current applied to the brain. The study focuses on children and young adults with Autism Spectrum Disorders (ASD) to see if it can help reduce symptoms like repetitive behaviors and hyperactivity. The electrical current aims to improve brain function by enhancing communication between brain cells. tDCS has been proposed as a new intervention method in ASD with the potential to improve cognitive, motor, and social communication abilities.

Who is the study for?

This trial is for children and young adults aged 4-17 with Autism Spectrum Disorder (ASD). Participants must have an IQ score of at least 70 and be able to speak in simple sentences. It's not open to those with brain injuries, implants, pacemakers, hearing or visual impairments, epilepsy, or other brain abnormalities.

What is being tested?

The study is testing the safety and impact of tDCS—a non-invasive brain stimulation technique—on the cerebellum area of kids with ASD. The focus is on whether it can reduce repetitive behaviors and hyperactivity associated with ASD.

What are the potential side effects?

Potential side effects from tDCS may include discomfort at the site of stimulation, headache, fatigue, nausea or itching under the electrode. Serious side effects are rare but could involve seizures or mood changes.

Eligibility Criteria

Inclusion Criteria

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

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I am between 4 and 17 years old.

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I have been diagnosed with Autism Spectrum Disorder (ASD).

Exclusion Criteria

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

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I have brain abnormalities not related to autism.

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I have hearing or vision problems.

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I have been diagnosed with epilepsy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-intervention at 1 week and post-intervention at 1 week and 1 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-intervention at 1 week and post-intervention at 1 week and 1 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-intervention at 1 week and post-intervention at 1 week and 1 month for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of tDCS associated side effects assessed by tDCS Safety Assessment

Secondary study objectives

Change in Autism Spectrum Disorder Symptoms assessed by Autism Spectrum Rating Scale

Change in Autism Spectrum Disorder Symptoms assessed by Cyberball/Social Ball Throwing Task

Change in Autism Spectrum Disorder Symptoms assessed by Dimensional Change Card Sort

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Full Administration of Transcranial Direct Current StimulationExperimental Treatment1 Intervention

Each subject will undergo psychosocial and behavioral assessments at a session prior to the administration of tDCS. The second session will include the tDCS Administration; a current of 1 mA will be administered over 20 minutes to the right crusI/II area of the cerebellum with a 15 second fade in period at the beginning and a 15 second fade out period at the end. During the tDCS administration, subjects will undergo functional MRI scanning. After the tDCS administration, subjects will repeat psychosocial and behavioral assessments.

Group II: Sham Administration of Transcranial Direct Current StimulationPlacebo Group1 Intervention

Each subject will undergo psychosocial and behavioral assessments at a session prior to the administration of tDCS. The second session will include the tDCS Administration; a current of 1mA increased over 15 seconds and immediately decreased over 15 seconds to provide sensation associated with tDCS. During the sham administration, subjects will undergo functional MRI scanning. After the tDCS administration, subjects will repeat psychosocial and behavioral assessments.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

tDCS

2017

Completed Phase 2

~630

0 / 5Eligibility 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) like transcranial Direct Current Stimulation (tDCS) and repetitive Transcranial Magnetic Stimulation (rTMS) work by modulating neuronal activity in specific brain regions. tDCS, for instance, applies a low electrical current to the cerebellum to alter neuronal excitability, potentially improving symptoms like repetitive behaviors and hyperactivity. These treatments are significant for ASD patients as they offer non-invasive options to target and alleviate core symptoms, thereby enhancing overall functioning and quality of life.

Non-Invasive Brain Stimulation for Children with Autism Spectrum Disorders: A Short-Term Outcome Study.Transcranial direct current stimulation in schizophrenia.