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NCT05008198Active, not recruiting

Assessing an EEG Biomarker of Response to TMS for Major Depression

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

Source: ClinicalTrials.gov · Last updated 22 Oct 2025

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
266 (actual)
First submitted
30 Jul 2021
Start date
19 Aug 2021
Primary completion date
30 Sept 2025
Lead sponsor
VA Office of Research and Development
Diseases
Depression
NCT number
NCT05008198

What you commit to

  • Study type: Observational
  • Participants enrolled: 266
  • From 19 Aug 2021 to the primary completion date, 30 Sept 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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

Other

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
White River Junction VA Medical Center, White River Junction, VT
Coordinator of this site? Confirm its status
White River JunctionUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.