Actively Recruiting

Phase Not Applicable
Age: 11Years - 25Years
All Genders
Healthy Volunteers
NCT04798274

Role of GABAergic Transmission in Auditory Processing in Autism Spectrum Disorder

Led by National Institute of Mental Health (NIMH) · Updated on 2026-04-09

106

Participants Needed

1

Research Sites

315 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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....

CONDITIONS

Official Title

Role of GABAergic Transmission in Auditory Processing in Autism Spectrum Disorder

Who Can Participate

Age: 11Years - 25Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability to provide informed assent and parent consent (parents do not need to speak English; consent forms available in English and Spanish)
  • Age 11 to 17 years for ASD participants; age 18 to 25 years for healthy volunteers
  • Diagnosis of autism spectrum disorder based on DSM-IV or DSM-5 criteria (ASD group)
  • Full Scale IQ above 70 measured by WASI-II
  • Right-handed
  • Normal hearing to complete behavioral assessments
  • Ability to provide informed consent (healthy volunteers)
Not Eligible

You will not qualify if you...

  • Non-English speakers
  • Known genetic disorders associated with ASD or that may increase risk or affect data integrity
  • Acquired neurological diseases such as stroke, tumor, cerebral palsy, or intracranial pathology
  • History of fainting spells of unknown cause that might be seizures
  • History of seizures, epilepsy, or immediate family history of epilepsy
  • Progressive neurological disorders
  • Uncontrolled chronic medical conditions that could cause emergencies, including cardiac or respiratory issues
  • Past or current clinically significant tinnitus
  • Any implant, prosthesis, or body alteration unsafe for MRI or TMS or that would interfere with data
  • Signs of increased intracranial pressure
  • Intracranial lesions unsafe for MRI or TMS
  • Head trauma within 6 months or head trauma with loss of consciousness over 5 minutes or lasting sequelae beyond headache
  • Pregnancy
  • Prior use of rTMS (repetitive transcranial magnetic stimulation)
  • Active or history of psychosis, bipolar disorder, recent severe substance use, or active suicidal intent
  • Current use of GABAergic medications or medications lowering seizure threshold
  • Inability to maintain stable pharmacotherapy for six weeks prior and during study
  • NIMH employees, staff, or immediate family members
  • Medical or neurological conditions increasing risks or compromising study compliance or data integrity

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

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Research Team

L

Lindsay M Oberman, Ph.D.

CONTACT

D

Daniel S Pine, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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