Assessing an EEG Biomarker of Response to TMS for Major Depression

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05008198
Study type	Observational
Source	VA Office of Research and Development
Contact	Paul Holtzheimer, MD
Phone	(802) 295-9363
Email	Paul.Holtzheimer@va.gov
Status	Recruiting
Phase
Start date	August 19, 2021
Completion date	September 30, 2026

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