Role of GABAergic Transmission in Auditory Processing in Autism Spectrum Disorder

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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....

Eligibility
Participation Requirements
Sex: All
Minimum Age: 11
Maximum Age: 25
Healthy Volunteers: t
View:

• 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

• 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.

Locations
United States
Maryland
National Institutes of Health Clinical Center
RECRUITING
Bethesda
Contact Information
Primary
Lindsay M Oberman, Ph.D.
lindsay.oberman@nih.gov
(301) 435-7962
Backup
Daniel S Pine, M.D.
daniel.pine@nih.gov
(301) 594-1318
Time Frame
Start Date: 2021-06-15
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 106
Treatments
Experimental: Active cTBS
This intervention involves active repetitive magnetic stimulation. The coil emits a magnetic field
Sham_comparator: Sham cTBS
This intervention involves sham (placebo) repetitive transcranial magnetic stimulation. The coil is blinded, but does not emit any magnetic field
Related Therapeutic Areas
Sponsors
Leads: National Institute of Mental Health (NIMH)

This content was sourced from clinicaltrials.gov