Exercise and Brain Stimulation for Post-stroke Depression

Recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Repetitive Transcranial Magnetic Stimulation Device
    Intervention Desc: Repeated non-invasive brain stimulation to the left dorsolateral prefrontal cortex.
    ARM 1: Kind: Experimental
    Label: rTMS
    Description: repetitive transcranial magnetic stimulation
    ARM 2: Kind: Experimental
    Label: AET+rTMS
    Description: Combined aerobic exercise and rTMS
    ARM 3: Kind: Experimental
    Label: Sham
    Description: Sham rTMS
  • Aerobic Exercise Other
    Intervention Desc: treadmill aerobic exercise; 3 sessions per week, 40 minutes per session
    ARM 1: Kind: Experimental
    Label: Aerobic Exercise
    Description: Treadmill aerobic exercise
    ARM 2: Kind: Experimental
    Label: AET+rTMS
    Description: Combined aerobic exercise and rTMS

Outcomes

Type Measure Time Frame Safety Issue
Primary Change from baseline in Hamilton Rating Scale for Depression weekly throughout the 8 week intervention as well as at the 8 week follow-up visit
Secondary Change from baseline in Self-selected walking speed weekly throughout the 8 week intervention as well as at the 8 week follow-up visit

Sponsors