About this trial
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
Qualifiers
age 21-70
stroke within the past 12 to 60 months
screen positive for probable major depressive disorder (PHQ-9 > 10) and HAM-D17 ≥ 14
residual paresis in the lower extremity (Fugl-Meyer LE motor score <34)
Disqualifiers
unable to ambulate at least 150 feet prior to stroke, or experienced intermittent claudication while walking
history of congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during ADL's
history of COPD or oxygen dependence
history of traumatic brain injury
Trial design
Treatments tested in this trial
- rTMS
- AEx
Treatment groups
Sponsors and collaborators
Medical University of South Carolina
Lead sponsor
National Institutes of Health (NIH)
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Duke University
Collaborator