Clinical Trial

Combining rTMS & Aerobic Exercise to Treat Depression and Improve Post-Stroke Walking

Study acronym: RESTORATION
Recruiting
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Summary
Investigators primary aim is to carry out a two-site, randomized, double-blind, sham-controlled, phase II trial to systematically examine the potential for aerobic exercise (AEx) to enhance the anti-depressant benefits of rTMS in individuals with post-stroke depression (PSD). Investigators propose to determine the efficacy of combining two known anti-depressant treatments shown to be effective in non-stroke depression, aerobic exercise (AEx) and repetitive transcranial magnetic stimulation (rTMS), on post-stroke depressive symptoms. This project is based on the idea that depression negatively affects the potential for the brain to adapt in response to treatment such that rehabilitation may not produce the same changes that it does in non-depressed individuals. Investigators believe that effective treatment for PSD will result in a virtuous cycle whereby reducing depression enhances response to rehabilitation, thereby facilitating functional gains. That is, effectively treating depression will enable individuals to better recover from stroke.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-06-24; most recent amendment 2026-07-12.
Trial Details
NCT Number NCT07050355
Lead Sponsor Medical University of South Carolina
Collaborators: National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Duke University
Conditions Stroke, Depression - Major Depressive Disorder, Walking Impairment
Enrollment 96 participants
Start Date 2024-11-01
Primary Completion 2029-08-31 (estimated)
Study Completion 2029-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-04