Assessing an EEG Biomarker of Response to TMS for Major Depression

NCT05008198 | Active Not Recruiting

• 1 other identifier: CSDR-001-19S
• Study Type: observational
• Target: 266
• Locations: 1 country
• Sites: 1

Brief 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

Depression

Keywords

depression; transcranial magnetic stimulation; electroencephalography; biomarkers

Outcome Measures

Primary Outcomes (1)

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

  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.

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

Study Arms (1)

Transcranial Magnetic Stimulation

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

Other: Transcranial Magnetic Stimulation

Interventions

Transcranial Magnetic Stimulation OTHER

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

Also known as: TMS; Repetitive Transcranial Magnetic Stimulation

Transcranial Magnetic Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Veterans with major depressive disorder (MDD) participating in the VA Clinical TMS Pilot Program. Given the complex nature of the Veteran population, the primary diagnosis of MDD may be comorbid with other disorders, including post-traumatic stress disorder (PTSD).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

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

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

Location

MeSH Terms

Conditions

Depression

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Paul Holtzheimer, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2021
• First Posted: August 17, 2021
• Study Start: August 19, 2021
• Primary Completion: September 30, 2025
• Study Completion (Estimated): September 30, 2026
• Last Updated: October 22, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)