RECRUITING

Role of GABAergic Transmission in Auditory Processing in Autism Spectrum Disorder

Conditions

Autism Spectrum Disorder GABA Language ASD MEG MRS

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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....

Official Title

Role of GABAergic Transmission in Auditory Processing in Autism Spectrum Disorder

Quick Facts

Study Start:2021-06-15

Study Completion:2027-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04798274

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:11 Years to 25 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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". * 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.	* 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 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 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.

Inclusion Criteria

Exclusion 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".
* 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.

* 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 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 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.

Contacts and Locations

Study Contact

Lindsay M Oberman, Ph.D.

CONTACT

(301) 435-7962

lindsay.oberman@nih.gov

Daniel S Pine, M.D.

CONTACT

(301) 594-1318

daniel.pine@nih.gov

Principal Investigator

Daniel S Pine, M.D.

PRINCIPAL_INVESTIGATOR

National Institute of Mental Health (NIMH)

Study Locations (Sites)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892

United States

Collaborators and Investigators

Sponsor: National Institute of Mental Health (NIMH)

Daniel S Pine, M.D., PRINCIPAL_INVESTIGATOR, National Institute of Mental Health (NIMH)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-06-15

Study Completion Date2027-06-30

Study Record Updates

Study Start Date2021-06-15

Study Completion Date2027-06-30

Terms related to this study

Keywords Provided by Researchers

GABA
Language
ASD
MEG
MRS

Additional Relevant MeSH Terms

Autism Spectrum Disorder