Stroke Clinical Trial
Official title:
Treating Depression and Enhancing Locomotor Recovery Post-stroke
This project will assess the effects of aerobic exercise training (AET), repetitive
transcranial magnetic stimulation (rTMS) or their combination on depressive severity as well
as locomotor function in persons with post-stroke depression (PSD). Both AET and rTMS are
established stand-alone treatments for non-stroke related depression, though neither has been
adequately studied post-stroke. Furthermore, substantive research indicates that AET improves
post-stroke locomotor function, thus offering a novel approach for treating PSD as well as an
established vehicle to study the effects of PSD on response to rehabilitation.
The purpose of this project is to determine the impact of AET, rTMS and their combination
(AET+rTMS) treatments on post-stroke depressive symptoms and locomotor function so as to
guide the development of a future clinical trial. A total of 40 depressed post-stroke
subjects will be randomly assigned to one of four groups 1) AET; 2) rTMS; 3) combined AET and
rTMS (AET+rTMS) or 4) control (sham rTMS) group (n=10 per condition; equally distributed with
mild and moderate MDD). Further, an additional 10 non-depressed post-stroke subjects will
complete 8 weeks of AET so as to allow us to determine the effects of PSD on response to
training (Aim 2). Training (AET, rTMS and AET+rTMS) will take place over an 8-week period,
three times per week on non-consecutive days. Measures of depression (HRSD17) as well as
self-selected walking speed (SSWS) will be performed prior to the initial treatment session
of each week as well as 8 weeks following cessation of treatment. Additional measures of
locomotor function (walking endurance and amount of daily community stepping) will be
assessed prior to training (pre), following 4 weeks of training (mid), upon completion of 8
weeks of training (post) as well as 8 weeks following cessation of training (follow-up),
allowing determination of the efficacy (and persistence) of training on these outcomes.
n/a
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