ACTIVE_NOT_RECRUITING

Assessing an EEG Biomarker of Response to TMS for Major Depression

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-08-19
Study Completion:2026-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05008198

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Veterans participating in the VA TMS Pilot Program age 18 years or older
  2. * 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
  3. * Diagnosis of MDD based on DSM-5 criteria and be currently depressed despite prior treatment with at least one adequate antidepressant treatment
  4. * 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
  1. * History of seizure disorder
  2. * Known structural or neurologic abnormalities present or close to the treatment site that would increase risk of seizure
  3. * History of brain surgery
  4. * History of recent traumatic brain injury (within 6 months) or any history of moderate to severe traumatic brain injury
  5. * Clinical evidence of severe or uncontrolled alcohol or substance use disorders within three months
  6. * Active withdrawal from alcohol or other substances of abuse
  7. * Implanted metal device in the head that would increase the risk of TMS
  8. * Metal in the head that would increase the risk of TMS
  9. * Current psychosis

Contacts and Locations

Principal Investigator

Paul Holtzheimer, MD
PRINCIPAL_INVESTIGATOR
White River Junction VA Medical Center, White River Junction, VT

Study Locations (Sites)

White River Junction VA Medical Center, White River Junction, VT
White River Junction, Vermont, 05001-3833
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Paul Holtzheimer, MD, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2021-08-19
Study Completion Date2026-09-30

Study Record Updates

Study Start Date2021-08-19
Study Completion Date2026-09-30

Terms related to this study

Keywords Provided by Researchers

  • depression
  • transcranial magnetic stimulation
  • electroencephalography
  • biomarkers

Additional Relevant MeSH Terms

  • Depression