Assessing an EEG Biomarker of Response to TMS for Major Depression

NCT05008198 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 266

Last updated 2025-10-22

No results posted yet for this 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.

Conditions

Interventions

OTHER

Transcranial Magnetic Stimulation

Transcranial Magnetic Stimulation is delivered as part of routine care and is not managed by this observational study.

Sponsors & Collaborators

  • VA Palo Alto Health Care System

    collaborator FED
  • Minneapolis Veterans Affairs Medical Center

    collaborator FED
  • Providence VA Medical Center

    collaborator FED
  • James A. Haley Veterans Administration Hospital

    collaborator FED
  • White River Junction Veterans Affairs Medical Center

    collaborator FED
  • Emory University

    collaborator OTHER
  • University of California, Los Angeles

    collaborator OTHER
  • Edward Hines Jr. VA Hospital

    collaborator FED
  • VA Greater Los Angeles Healthcare System

    collaborator FED
  • VA Pittsburgh Healthcare System

    collaborator FED
  • San Diego Veterans Healthcare System

    collaborator FED
  • Michael E. DeBakey VA Medical Center

    collaborator FED
  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Paul Holtzheimer, MD · White River Junction VA Medical Center, White River Junction, VT

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-19
Primary Completion
2025-09-30
Completion
2026-09-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05008198 on ClinicalTrials.gov