Assessing an EEG Biomarker of Response to TMS for Major Depression

August 10, 2023 updated by: VA Office of Research and Development

Assessing an Electroencephalography (EEG) Biomarker of Response to Transcranial Magnetic Stimulation 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Vermont
      • White River Junction, Vermont, United States, 05001-3833
        • Recruiting
        • White River Junction VA Medical Center, White River Junction, VT
        • Contact:
        • Principal Investigator:
          • Paul Holtzheimer, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1) Baseline, pre-treatment and 2) 6 weeks, treatment completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Collaborators

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

Investigators

  • Principal Investigator: Paul Holtzheimer, MD, White River Junction VA Medical Center, White River Junction, VT

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 19, 2021

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

July 30, 2021

First Submitted That Met QC Criteria

August 9, 2021

First Posted (Actual)

August 17, 2021

Study Record Updates

Last Update Posted (Actual)

August 15, 2023

Last Update Submitted That Met QC Criteria

August 10, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSDR-001-19S

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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