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NCT07050355
Combining rTMS & Aerobic Exercise to Treat Depression and Improve Post-Stroke Walking
Conditions: Stroke, Depression - Major Depressive Disorder, Walking Impairment
Sex: All
Ages: 21 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 96
Sponsor: Medical University of South Carolina
Location: Duke University School of Medicine Durham North Carolina
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.
Eligibility Criteria
Inclusion criteria:
* age \>21
* stroke at least 12 months prior
* screen positive for depressive symptoms (PHQ-9 \> 5) and HAM-D17 ≥ 12
* residual paresis in the lower extremity (Fugl-Meyer LE motor score \
Source: ClinicalTrials.gov (NCT07050355). StuddyBuddy aggregates publicly available trial information.