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Typically Developing (TD): excitatory, then inhibitory, then sham rTMS for Autism

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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

rTMS

2016

Completed Phase 3

~840

fMRI

2019

Completed Phase 3

~1730

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH

2,786 Previous Clinical Trials

2,689,629 Total Patients Enrolled

Yale UniversityLead Sponsor

1,853 Previous Clinical Trials

2,738,481 Total Patients Enrolled

Vaughn Steele, MDPrincipal InvestigatorYale University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this medical study currently accepting new participants?

"According to the information provided on clinicaltrials.gov, this specific trial is not currently seeking participants. Its initial posting date was February 1st, 2024 and it was most recently updated on January 9th, 2024. However, there are currently 306 other ongoing clinical trials actively enrolling patients at the moment."

Answered by AI

Which group of individuals is more suitable to be enrolled in this research study?

"Patients who are between the ages of 18 and 35 and have a diagnosis of autism spectrum disorder are eligible to participate in this study. The clinical trial aims to enroll approximately 80 patients."

Answered by AI