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Transcranial Magnetic Stimulation for Autism Spectrum Disorder

N/A

Recruiting

Led By Vaughn Steele, MD

Research Sponsored by Yale University

Eligibility Criteria Checklist

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

Must have

For Control Group: No current or history of psychiatric disorders, other than simple phobia, and/or primary relatives with ASD

No primary relatives with history of any neurological disorder with a potentially hereditary basis, including epilepsy or MS

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during each fmri, up to 5 hours

Awards & highlights

No Placebo-Only Group

Summary

This trial is an observational study that aims to test the effect of different types of brain stimulation on how young adults with autism understand and think about other people's thoughts and feelings. The researchers want to know

Who is the study for?

This trial is for young adults with Autism Spectrum Disorder (ASD) who can undergo MRI scans and TMS sessions. It's not suitable for individuals without ASD or those who cannot safely have these procedures due to other medical conditions.

What is being tested?

The study tests if transcranial magnetic stimulation (TMS) at the right temporoparietal junction affects brain activity related to social understanding in people with autism, compared to non-autistic individuals.

What are the potential side effects?

TMS may cause discomfort at the stimulation site, headache, lightheadedness, or seizures in rare cases. The fMRI procedure is generally safe but might be uncomfortable due to loud noises and confined space.

Eligibility Criteria

Inclusion Criteria

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

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I don't have psychiatric disorders, except maybe simple phobia, and no family history of ASD.

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None of my close relatives have had hereditary neurological disorders.

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I have never had a serious head injury.

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I have never had a neurological disorder or neurosurgery.

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I do not have any major medical conditions like cancer or heart failure.

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I am not currently taking any medications for mental health or to prevent or cause seizures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during each fmri, up to 5 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during each fmri, up to 5 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and during each fmri, up to 5 hours for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Mentalizing Task Related (MTR) neural activity in the mentalizing network

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: Typically Developing (TD): excitatory, then inhibitory, then sham rTMSExperimental Treatment2 Interventions

Participants in this group will undergo fMRI pre- and post- rTMS. Each will receive an excitatory, inhibitory and sham rTMS to the right temporoparietal junction (TPJ) on mentalizing task-related (MTR) activity over 4 study visits.

Group II: ASD: excitatory, then inhibitory, then sham rTMSExperimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

fMRI

2019

Completed Phase 3

~1730

rTMS

2016

Completed Phase 3