RecruitingNot ApplicableNCT06773949

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

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


Sponsor

The Royal Ottawa Mental Health Centre

Enrollment

20 participants

Start Date

Dec 15, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this study is to collect feasibility data on combining structured exercise aimed to improve physical fitness, and intermittent TBS (iTBS) in treating individuals diagnosed with difficult-to-treat depression who are physically inactive. By conducting this trial, we will compare the therapeutic benefits of the combined approach against the standard treatment of iTBS alone (without exercise). These findings will be used to inform future large-scale projects in which we will investigate, in a larger sample size, whether structured exercise aimed to improve fitness as recommended by most public exercise guidelines (i.e., ≥3x/week, moderate-to-vigorous intensity) serves as an active ingredient that amplifies the effectiveness of iTBS. Ultimately, the insights gained from this study will be valuable for clinicians seeking to alleviate depressive symptoms in MDD through neuromodulation techniques such as iTBS.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether doing exercise before brain stimulation therapy (called rTMS — repetitive transcranial magnetic stimulation) improves outcomes for people with depression that has not responded to antidepressant medications. rTMS uses magnetic pulses to stimulate areas of the brain linked to mood. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with major depression or persistent depressive disorder (without psychosis) - At least one antidepressant medication in the current episode has not helped you - Your depression symptoms are moderate to severe (score of 15 or higher on a standard rating scale) - You have not changed your medications or therapy for at least 4 weeks - You are currently physically inactive - You are able to do structured exercise **You may NOT be eligible if...** - You have a different primary psychiatric diagnosis - You have changed medications recently - You are already physically active - You have a medical condition that prevents you from exercising safely Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETheta burst stimulation

Cool B70 cooled-coil (left DLPFC) with X100 MagPro rTMS Device (Magventure A/S, Farum, Denmark)


Locations(1)

Royal Ottawa Mental Health Centre

Ottawa, Ontario, Canada

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NCT06773949


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