Identifying EEG Biomarkers for Predicting TMS Response in Veterans with Depression
Assessing an Electroencephalography (EEG) Biomarker of Response to Transcranial Magnetic Stimulation for Major Depression
This study is testing if certain brain activity patterns can help predict how well veterans with tough-to-treat depression respond to a treatment called transcranial magnetic stimulation (TMS).
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (White River Junction, Vermont) |
| Trial ID | NCT05008198 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess EEG biomarkers that may predict the response of veterans with treatment-resistant depression (TRD) to transcranial magnetic stimulation (TMS). A total of 400 veterans will undergo EEG scans at baseline, every fifth treatment session, and at the end of treatment to identify patterns in brain activity associated with treatment outcomes. The study will explore various EEG markers, including gamma oscillations and theta cordance, to enhance understanding of how TMS affects depression. The ultimate goal is to create a framework for identifying and testing additional EEG-based biomarkers for depression and other psychiatric conditions.
Who should consider this trial
Good fit: Ideal candidates are veterans aged 18 and older with a diagnosis of major depressive disorder who have not responded to previous antidepressant treatments.
Not a fit: Patients with a history of seizure disorders, significant brain injuries, or severe substance use issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment strategies for veterans suffering from treatment-resistant depression.
How similar studies have performed: While the use of EEG biomarkers in predicting treatment response is an emerging field, similar studies have shown promise in identifying neuroimaging markers for various psychiatric conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 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
Where this trial is running
White River Junction, Vermont
- White River Junction VA Medical Center, White River Junction, VT — White River Junction, Vermont, United States (Recruiting)
Study contacts
- Principal investigator: Paul Holtzheimer, MD — White River Junction VA Medical Center, White River Junction, VT
- Study coordinator: Paul Holtzheimer, MD
- Email: Paul.Holtzheimer@va.gov
- Phone: (802) 295-9363
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.