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New treatment option for Autism Spectrum Disorder
Official title Role of GABAergic Transmission in Auditory Processing in Autism Spectrum Disorder
ClinicalTrials.gov ID: NCT04798274
What this study is testing
- What it's testing
- Background: Autism spectrum disorder (ASD) is a complex neurodevelopmental syndrome. Researchers think brain development may be controlled by gamma-aminobutyric acid (GABA).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 11 to 25. Healthy volunteers may be eligible.
You may be able to join if
- Pilot Phase
- 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...
- 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...
You likely can't join if
- Participants will be screened to exclude individuals with co-occurring neurological or medical conditions that might confound the results, as well as...
- 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...
- History of fainting spells of unknown or undetermined etiology that might constitute seizures;
See the full eligibility criteria
Who can join
- Pilot Phase
- 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...
- 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...
- 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.
What rules you out
- Participants will be screened to exclude individuals with co-occurring neurological or medical conditions that might confound the results, as well as to exclude people in whom MRI or rTMS might result in increased risk...
- 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...
- 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. Main Study Phase
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 11 years to 25 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.