Who is eligible for clinical trial NCT06670040?

Participants must meet protocol criteria for ASD. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT06670040 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-02-10

Theta Burst Stimulation for Refractory Depression in Autism Spectrum Disorder (NCT06670040)

🔵 Active, Not Recruiting Observational / Diagnostic 🩺 Clinical Procedure Protocol Sponsor: Children's Hospital Medical Center, Cincinnati

🩺 Plain-English Summary (8th-Grade Level)

Evaluate the efficacy of accelerated theta burst stimulation (aTBS) in reducing depressive symptoms in autism spectrum disorder (ASD)

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (8 items).

Location: Cincinnati Childrens Hospital Medical Center — Cincinnati, Ohio

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Fluent in English and able to volunteer in the informed consent process and provide spontaneous narrative description of key elements, risks, and benefits of the study.
Aged 13-26, inclusive.
Full-scale intelligence quotient ≥ 70.
Diagnosis of ASD using criteria from Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5). Diagnosis will be confirmed by study psychologist/social worker and supported by scoring in the ASD on the Autism Diagnostic Observation Schedule (ADOS-2).
Diagnosis of MDD based on psychologist diagnosis and DSM-5-based structural diagnostic interview determine via KSADS
Exhibiting treatment resistance to at least one antidepressant drug treatment of adequate dose and duration.
Symptoms of moderate to severe depression according to Hamilton Depression Rating Scale ≥ 20 which must be maintained through lead-in period.
Participants are not required to discontinue current interventions but must agree to attempt to keep medications and other interventions stable during the study.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Participation in an investigational drug trial within the past three months.
Active substance use disorder (excluding tobacco use) within the past 6 months.
Contraindications to Transcranial Magnetic Stimulation including, but not limited to, a history of epilepsy, the presence of metallic foreign bodies, or implanted medical devices (e.g. pacemaker, medical pump).
Actively suicidal (i.e., suicidal ideation with plan and intent) or deemed at high risk for suicide.
Current use of anticonvulsant, barbiturate, lithium, or benzodiazepine medications.
Prior rTMS treatment.
For female subjects of childbearing potential, a positive urine pregnancy test.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Cincinnati Childrens Hospital Medical Center — Cincinnati, Ohio

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗