Is NCT04798274 recruiting in Bethesda, MD?

Yes, NCT04798274 is currently recruiting participants at its Bethesda, MD location. This autism spectrum disorder clinical trial is actively enrolling qualified participants.

How do I join the autism spectrum disorder clinical trial in Bethesda?

To join this clinical trial in Bethesda, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Bethesda clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Autism Spectrum Disorder Clinical Trial in Bethesda, MD

About This Autism Spectrum Disorder Study in Bethesda

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....

Sponsor: National Institute of Mental Health (NIMH)

Who Can Participate

Inclusion Criteria

Pilot Phase Inclusion 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". Main Study Phase Inclusion criteria

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 Criteria

Participants will be screened to exclude individuals with co-occurring neurological or medical conditions that might confound the results, as well as to exclude subjects in whom MRI or rTMS might result in increased risk of side effects or complications. This accounts for the majority of the exclusion criteria listed: Exclusion criteria Participants will be screened to exclude individuals with neurological, psychological/behavioral or medical conditions, as well as to exclude subjects in whom MRI or rTMS might result in increased risk of side effects or complications. This accounts for the majority of the exclusion criteria listed: Pilot Phase

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.

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.

Signs of increased intracranial pressure;

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Bethesda?

Yes, this clinical trial (NCT04798274) has an active research site in Bethesda, MD that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Autism Spectrum Disorder Treatment Options in Bethesda, MD

If you're searching for autism spectrum disorder treatment options in Bethesda, MD, this clinical trial (NCT04798274) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Bethesda research site is actively enrolling participants for this clinical trial. You'll receive care from experienced autism spectrum disorder specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all autism spectrum disorder clinical trials near you to find additional studies recruiting in your area.

Autism Spectrum Disorder Clinical Trial in Bethesda, MD

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