Study of Exercise to Enhance rTMS Treatment for Adults with Difficult-to-Treat Depression A Randomized Trial to Test Combining Exercise and iTBS Therapy

What this Trial Is About

Researchers are investigating whether combining structured exercise with intermittent Theta Burst Stimulation iTBS can improve treatment outcomes for individuals with difficult-to-treat depression who are physically inactive. This pilot trial aims to collect feasibility data comparing this combined approach against standard iTBS treatment alone. The study focuses on treatment-resistant depression and seeks to understand if exercise enhances the brains response to neuromodulation therapies like iTBS. Participants will be randomly assigned to one of two groups. The intervention group will first engage in 4 weeks of moderate-to-vigorous exercise sessions lasting about one hour, three times per week, followed by 6 weeks of combined iTBS treatment and exercise. The control group will have 4 weeks of stable treatment without changes in medication or activity, followed by 6 weeks of iTBS alone. In both groups, iTBS will be administered five times per week with each session lasting approximately 3 minutes. During the study, participants will undergo assessments at multiple time points including before and after iTBS treatment and at a 6-week follow-up. These assessments include self-reported measures of depression, anxiety, suicidal thoughts, and hopelessness, as well as brain imaging, neurophysiology tests, grip strength, and physical measurements. The study will evaluate how feasible it is to deliver the combined treatment and will monitor adherence, symptom changes, and neuroplasticity effects over the course of the trial, which lasts approximately 10 weeks plus follow-up.

Feasibility Trial of Exercise as a Priming Strategy for rTMS Treatment in Difficult-to-Treat Depression