Assessing an EEG Biomarker of Response to TMS for Major Depression

Last updated: October 20, 2025
Sponsor: VA Office of Research and Development
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Depression

Treatment

Transcranial Magnetic Stimulation

Clinical Study ID

NCT05008198
CSDR-001-19S
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 thisstudy and to allow linking such data to data collected as part of the TMS PilotProgram

  • Diagnosis of MDD based on DSM-5 criteria and be currently depressed despite priortreatment with at least one adequate antidepressant treatment

  • Receiving stable doses of psychiatric medications (no dose changes for >4 weeksprior to study entry), in stable psychotherapy, or receiving no psychiatricmedications and/or psychotherapy

Exclusion

Exclusion Criteria:

  • History of seizure disorder

  • Known structural or neurologic abnormalities present or close to the treatment sitethat would increase risk of seizure

  • History of brain surgery

  • History of recent traumatic brain injury (within 6 months) or any history ofmoderate to severe traumatic brain injury

  • Clinical evidence of severe or uncontrolled alcohol or substance use disorderswithin 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

Study Design

Total Participants: 266
Treatment Group(s): 1
Primary Treatment: Transcranial Magnetic Stimulation
Phase:
Study Start date:
August 19, 2021
Estimated Completion Date:
September 30, 2026

Study Description

The goals of this study are to: (1) test a potential predictive resting EEG biomarker of antidepressant response (differential patters of gamma oscillations) in a large sample of Veterans with TRD receiving TMS (N=400); (2) assess whether a second putative biomarker (early changes in theta cordance during treatment) predict eventual response to TMS, as well as, leverage this large sample to identify other potential biomarkers (such as markers of early versus late response to TMS, markers of response to other TMS parameters (e.g., 5 Hz, 1 Hz or theta burst TMS), and markers of change with treatment that may speak to mechanism); and (3) create an infrastructure to rapidly identify and test additional EEG-based biomarkers of treatment response in patients with depression and other psychiatric conditions.

Connect with a study center

  • White River Junction VA Medical Center, White River Junction, VT

    White River Junction, Vermont 05001-3833
    United States

    Site Not Available

  • White River Junction VA Medical Center, White River Junction, VT

    White River Junction 5242889, Vermont 5242283 05001-3833
    United States

    Site Not Available

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