Who is eligible for clinical trial NCT05008198?

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

Does clinical trial NCT05008198 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 2025-10-20

Assessing an EEG Biomarker of Response to TMS for Major Depression (NCT05008198)

🔵 Active, Not Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: VA Office of Research and Development

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

Veterans with treatment resistant depression (TRD) have the opportunity to receive transcranial magnetic stimulation (TMS) treatment via the VA's National TMS Clinical Pilot Program. While some see improvement with their depression, others do not. Therefore, it may be beneficial to be able to predict with biomarkers what participants may see improvement with their treatment. Electroencephalography (EEG) is a means to identify such biomarkers. Four hundred Veterans with TRD will be enrolled in this trial to determine whether neuroimaging biomarkers of repetitive transcranial magnetic stimulation (TMS) can be prospectively replicated in a large ecologically valid sample. Participants will have a total of EEG scans at baseline, every 5th treatment session, and at the end of treatment for a total of 7 EEG scans.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (10 items).

Location: White River Junction VA Medical Center, White River Junction, VT — White River Junction, Vermont

📋 "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).

Veterans participating in the VA TMS Pilot Program age 18 years or older
Able to provide written informed consent to participate in the EEG portion of this study and to allow linking such data to data collected as part of the TMS Pilot Program
Diagnosis of MDD based on DSM-5 criteria and be currently depressed despite prior treatment with at least one adequate antidepressant treatment
Receiving stable doses of psychiatric medications (no dose changes for \>4 weeks prior to study entry), in stable psychotherapy, or receiving no psychiatric medications and/or psychotherapy

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
History of seizure disorder
Known structural or neurologic abnormalities present or close to the treatment site that would increase risk of seizure
History of brain surgery
History of recent traumatic brain injury (within 6 months) or any history of moderate to severe traumatic brain injury
Clinical evidence of severe or uncontrolled alcohol or substance use disorders within three months
Active withdrawal from alcohol or other substances of abuse
Implanted metal device in the head that would increase the risk of TMS
Metal in the head that would increase the risk of TMS
Current psychosis

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

📍 All Participating Trial Locations (1 Sites)

White River Junction VA Medical Center, White River Junction, VT — White River Junction, Vermont

💰 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 ↗