Assessing an EEG Biomarker of Response to TMS for Major Depression

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial magnetic stimulation

Other

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

Other names: TMS; Repetitive Transcranial Magnetic Stimulation

Primary outcomes

Change in Inventory of Depressive Symptomatology-Self Report (IDS-SR)

Time frame: 1) Baseline, pre-treatment and 2) 6 weeks, treatment completion

The IDS-SR is a 30-item self-report depressive symptom severity rating scale. The IDS-SR has been shown to have highly acceptable psychometric properties and has been found to be a treatment sensitive measures of symptom severity in depression. Each question is on a scale of 0 to 4. The IDS-SR has a score range between 0 to 84, with a higher score reflecting higher symptom severity in depression.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

Edward Hines Jr. VA Hospital
Emory University
James A. Haley Veterans Administration Hospital
Michael E. DeBakey VA Medical Center
Minneapolis Veterans Affairs Medical Center
Providence VA Medical Center
San Diego Veterans Healthcare System
University of California, Los Angeles
VA Greater Los Angeles Healthcare System
VA Palo Alto Health Care System
VA Pittsburgh Healthcare System
White River Junction Veterans Affairs Medical Center

Registry information

Official study title

Assessing an Electroencephalography (EEG) Biomarker of Response to Transcranial Magnetic Stimulation for Major Depression

Important dates

Study start: 2021
Primary completion: 2025
Study completion: 2026
First posted: Aug 17, 2021
Registry last updated: Oct 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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