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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-70
SponsorMedical University of South Carolina

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

96 Participants
are divided into 3 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