Understanding Brain Activity in Autism Spectrum Disorder
This study is looking into how a brain chemical called gamma-aminobutyric acid (GABA) might be involved in autism spectrum disorder (ASD). Researchers want to see if a treatment called Continuous Theta Burst Stimulation (cTBS) can temporarily change how different parts of the brain communicate. cTBS uses a device to deliver short bursts of magnetic stimulation to the brain. The study aims to understand if changes in GABA levels and brain connections can predict how people with ASD process sounds and language. To be eligible, you must be right-handed and between 11 and 17 years old with ASD, or a healthy volunteer between 18 and 25 years old. The study is currently unclear on its recruitment status and plans to enroll 106 participants.
- Study design
- This is an interventional study that will compare measurements within each participant before and after treatment. It is a proof-of-mechanism study.
- What's involved
- You will have about seven study visits, which may be spread out over up to six months. These visits include medical and neurological exams, psychological tests, a hearing test, an MRI, and brain activity measurements (MRS, MEG, fcMRI) before and after cTBS.
- Compensation
- Not stated in the trial record.
- Follow-up
- Brain activity measurements (MRS, MEG, fcMRI) will be taken immediately before and after the rTMS treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT04798274
Role of GABAergic Transmission in Auditory Processing in Autism Spectrum Disorder
Recruiting
NAAges 11–25InterventionalBasic scienceNational Institute of Mental Health (NIMH)Government-funded
~106 participants
Updated 2026-04-09 on ClinicalTrials.gov
What's tested:Continuous Theta Burst Stimulation
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
MRS
Measured over immediately pre and post rTMS
+3 more outcomes measured
Conditions
Where it's being run
1 sites across 1 statesMaryland1
Study leadership
- Daniel S Pine, M.D. · PRINCIPAL_INVESTIGATOR · National Institute of Mental Health (NIMH)
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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".
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
Non-English Speakers
Known Neurological Disorder
Known Psychiatric Disorder
Known genetic disorder (e.g., NF1, tuberous sclerosis), acquired neurologic disease (e.g. stroke, tumour), cerebral palsy, intracranial pathology or significant dysmorphology;
History of fainting spells of unknown or undetermined etiology that might constitute seizures;
History of seizures, diagnosis of epilepsy, or immediate (1st degree relative) family history epilepsy;
Chronic (particularly) uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.);
Past or Current History of Tinnitus
Any implant, prosthesis or other permanent alteration of the body that, in the opinion of the investigator, would be unsafe with MRI or TMS or that would produce an artifact that would compromise the integrity of data;
Signs of increased intracranial pressure;
Intracranial lesion (including incidental finding on MRI) that, in the opinion of the investigator, would be unsafe with MRI or TMS or that would produce an artifact that would compromise the integrity of data;
History of any head trauma within 6 months of screening, or beyond 6 months prior to screening, history of head trauma with evidence of traumatic abnormality appearing on a brain scan, or with loss of consciousness \>5 minutes, or with other sequelae, excluding headache, lasting \> 24 hours.
Pregnancy;
Participants who have received rTMS less than 7 days prior to enrollment;
Individuals currently taking GABAergic medications or any other medication that, in the opinion of the investigator, significantly lowers seizure threshold;
Individuals for whom it is not safe or appropriate to remain on a stable pharmacotherapy (for nonexclusionary medications) for six weeks prior to and over the course of their participation in the study;
A current NIMH employee or staff or their immediate family member.
Non-English Speakers
Known genetic disorder that is either associated with the ASD diagnosis or that in the opinion of the investigator may increase the risk to the participant or compromise the integrity of the data;
Acquired neurologic disease (e.g. stroke, tumour), cerebral palsy, intracranial pathology or significant dysmorphology;
History of fainting spells of unknown or undetermined etiology that might constitute seizures;
History of seizures, diagnosis of epilepsy, or immediate (1st degree relative) family history epilepsy;
Any progressive (e.g., neurodegenerative) neurological disorder;
Chronic (particularly) uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.);
Past or Current history of clinically significant tinnitus as determined by an audiologist or other-licensed clinician.
Any implant, prosthesis or other permanent alteration of the body that, in the opinion of the investigator, would be unsafe with MRI or TMS or that would produce an artifact that would compromise the integrity of data;
Signs of increased intracranial pressure;
Intracranial lesion (including incidental finding on MRI) that, in the opinion of the investigator, would be unsafe with MRI or TMS or that would produce an artifact that would compromise the integrity of data;
History of any head trauma within 6 months of screening, or beyond 6 months prior to screening, history of head trauma with evidence of traumatic abnormality appearing on a brain scan, or with loss of consciousness \>5 minutes, or with other sequelae, excluding headache, lasting \> 24 hours.
Pregnancy;
Participants who have received prior rTMS;
Active or History of psychosis, bipolar disorder, active severe substance use disorders (within the last month), have active suicidal intent or plan as detected on screening instruments or in the investigator team's opinion is likely to attempt suicide within 6 months;
Individuals currently taking GABAergic medications or any other medication or medication change that, in the opinion of the investigator, significantly lowers seizure threshold;
Past or present medical or neurological condition, disease, disorder, genetic finding, or injury that, in the opinion of the Investigator, may significantly increase the potential risks of study participation, reduce or compromise a subject's ability to fully comply with all study requirements for the duration of the study or may compromise the integrity of the data.
What this trial measures
- MRSimmediately pre and post rTMS
GABA+/Cr concentrations in the left pSTC
- MEGimmediately pre and post rTMS
Evoked fields and Spectral Power
- fcMRIimmediately pre and post rTMS
BOLD correlations across pre-defined ROIs.
- DTIimmediately pre and post rTMS
Diffusion tensor derived parameters in the auditory radiations and arcuate fasciculus.