Wednesday, April 2, 2025
4/2/2025
Maintenance rTMS for depression (Maitr-De) - Abstract Repetitive transcranial magnetic stimulation (rTMS) has emerged as a promising intervention for treatment- resistant depression (TRD), yet substantial uncertainties persist regarding its efficacy as a maintenance treatment. This prospective study seeks to investigate the efficacy of maintenance rTMS in individuals with TRD who have previously responded to an acute course of rTMS. In the R61 phase of the study, we will recruit 75 participants across three study sites, the University of California San Diego, Cornell University, and Australian National University, into a double-blind, three-arm maintenance treatment trial. In this trial, participants will be randomized to receive either standard maintenance rTMS, clustered maintenance rTMS, or sham maintenance rTMS for a duration of 6 months. Our primary aim is to examine the efficacy of maintenance rTMS on sustaining connectivity between the dorsolateral prefrontal cortex (DLPFC) and subgenual cingulate cortex (SGC) measured through concurrent TMS and electroencephalography (TMS-EEG) at baseline and every six weeks throughout the 6-month treatment period. We will also assess changes in depressive symptom severity using clinical scales including the Montgomery-Asberg Depression Rating Scale (MADRS) as a secondary outcome measure. It is hypothesized that stimulation with clustered maintenance rTMS will demonstrate superiority in sustaining DLPFC-SGC connectivity compared with standard maintenance rTMS and sham maintenance rTMS. In the R33 phase, we propose to conduct a randomized 2-arm double-blind, parallel clinical trial comparing the superior arm of the R61 phase with sham maintenance rTMS in 144 patients with TRD who have responded to an acute course of rTMS treatment. The primary outcome of interest for this phase will be clinical symptom maintenance measured with the MADRS, with the expectation that the active arm will lead to significantly better sustained symptom relief than sham. As a secondary analyses, DLPFC-SGC connectivity derived through TMS- EEG will be evaluated to compare between treatment arms and correlate with symptom change. It is anticipated that active maintenance rTMS will lead to more sustained DLPFC-SGC connectivity than sham and that connectivity will correlate with symptoms, providing a biomarker of treatment response that can potentially be used for prescriptive selection of patients for maintenance treatment and as a measure of neuroplasticity for continued scientific discovery. The overall goal of this research is to determine the most effective form of maintenance rTMS treatment for patients with TRD and to understand the neurobiological underpinning of maintenance rTMS treatment response.
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