RecruitingNot Applicable

Role of GABAergic Transmission in Auditory Processing in Autism Spectrum Disorder

United States106 participantsStarted 2021-06-15

Plain-language summary

Background: Autism spectrum disorder (ASD) is a complex neurodevelopmental syndrome. Researchers think brain development may be controlled by gamma-aminobutyric acid (GABA). They want to learn how abnormalities in the GABA system may contribute to ASD. Objective: To see if repetitive transcranial magnetic stimulation (rTMS) creates short-term changes in how different parts of the brain communicate. Eligibility: Right-handed people ages 11-17 with ASD, and healthy volunteers ages 18-25. Design: Participants will be screened with: Medical history Physical exam Medicine review Neurological exam Psychological tests and rating scales Forms and surveys. Participants will have a hearing test and ear exam. Participants will have magnetic resonance imaging (MRI) of the brain. They will lie on a table that moves in and out of the MRI scanner. They may look at a screen while in the scanner. A coil will be placed over their head. Participants will have magnetic resonance spectroscopy. It takes pictures of chemicals in the brain using the MRI scanner. Participants will have magnetoencephalography. They will sit in a chair. A helmet with magnetic field sensors will be placed on their head. Participants will have TMS. A wire coil will be held on their scalp. A brief electrical current will pass through the coil. Participants will have electromyography. Sticky pad electrodes will be placed on the skin during TMS. The electrical activity of their muscles will be measured. Participants will have rTMS. It uses short bursts of magnetic pulses to affect brain activity. ASD participants may have visits scheduled as often as 1 time a week or as far apart as 2 months based on the participants or study team's availability. Healthy volunteers will have 3 visits over 3-4 weeks....

Who can participate

Age range

11 Years – 25 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* INCLUSION CRITERIA: Pilot Phase Inclusion criteria * Ability to provide informed consent * Age: 18-25 years * Must meet the definition of "Healthy Control" having completed the screening assessment under protocol 01-M-0254, "The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers" or under protocol 17-M-0181, "Recruitment and Characterization of Research Volunteers for NIMH Intramural Studies". Main Study Phase Inclusion criteria * Ability to provide informed assent and parent consent (Parents of children enrolling on the study do not need to be able to speak English. A consent form is available in English or Spanish for parents of children who enroll.) * Age: 11-17 years * Community Diagnosis of ASD based on DSM-IV or DSM-5 criteria (reviewed by a member of the Neurodevelopmental and Behavioral Phenotyping Service) * Wechsler Abbreviated Scale of Intelligence, Second Edition (WASI-II). WASI-II will be used as a measure of intellectual function. Children will be included when FSIQ \> 70. * Right-handed: to reduce heterogeneity. * Hearing: Normal hearing in order to complete the behavioural assessments. EXCLUSION CRITERIA: Participants will be screened to exclude individuals with co-occurring neurological or medical conditions that might confound the results, as well as to exclude subjects in whom MRI or rTMS might result in increased risk of side effects or complications. This accounts for the majority of the exclusion criteria listed: Exc…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

MRS

Timeframe: immediately pre and post rTMS

MEG

Timeframe: immediately pre and post rTMS

fcMRI

Timeframe: immediately pre and post rTMS

DTI

Timeframe: immediately pre and post rTMS

Trial details

NCT IDNCT04798274

SponsorNational Institute of Mental Health (NIMH)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2027-06-30

Contact for this trial

Lindsay M Oberman, Ph.D.

(301) 435-7962 lindsay.oberman@nih.gov

View on ClinicalTrials.gov More Autism Spectrum Disorder trials

Plain-language summary

Who can participate

Age range

11 Years – 25 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.