An interventional study of Aerobic exercise and Repetitive transcranial magnetic stimulation in Stroke, sponsored by Medical University of South Carolina. Completed at 1 site in United States. Open to participants aged 50 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-05-14.
Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Treatment
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 23 is below the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Medical University of South Carolina is the lead sponsor of 852 studies on the registry; 165 are open to participants now.
Of its 128 completed or terminated interventional studies of FDA-regulated products, 101 (79%) have results posted.
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Exclusion Criteria:
Treadmill aerobic exercise
Behavioral: Aerobic exercise
repetitive transcranial magnetic stimulation
Other: Repetitive transcranial magnetic stimulation
Combined aerobic exercise and rTMS
Behavioral: Aerobic exercise · Other: Repetitive transcranial magnetic stimulation
Sham rTMS
Other: Repetitive transcranial magnetic stimulation
treadmill aerobic exercise; 3 sessions per week, 40 minutes per session
Repeated non-invasive brain stimulation to the left dorsolateral prefrontal cortex.
Also known as: rTMS
Change From Baseline to Post Training in Hamilton Rating Scale for Depression
The Hamilton Rating Scale for Depression is a clinician-administered depression assessment scale containing 17 items pertaining to symptoms of depression experienced over the past week. A total score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a total score of 20 or higher indicates at least moderate severity depression. Score range 0-58. Higher total scores indicate higher levels of depression, while a score of 0 would indicate no depressive symptoms.
Time frame: assessed at baseline and weekly throughout the 8 week intervention. Change from baseline to week 8 reported as primary outcome
Change From Baseline to Week 8 in Self-selected Walking Speed
Time frame: assessed at baseline as well as weekly throughout the 8 week intervention. Change from baseline to week 8 reported as outcome
| Milestone | Aerobic Exercise | rTMS | AET+rTMS | Sham |
|---|---|---|---|---|
| Started | 4 | 6 | 6 | 7 |
| Completed | 4 | 5 | 5 | 6 |
| Not completed | 0 | 1 | 1 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 | 0 |
| Withdrew: Move out of area | 0 | 0 | 1 | 1 |
The Hamilton Rating Scale for Depression is a clinician-administered depression assessment scale containing 17 items pertaining to symptoms of depression experienced over the past week. A total score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a total score of 20 or higher indicates at least moderate severity depression. Score range 0-58. Higher total scores indicate higher levels of depression, while a score of 0 would indicate no depressive symptoms.
| units on a scale | Aerobic Exercise | rTMS | AET+rTMS | Sham |
|---|---|---|---|---|
| Change From Baseline to Post Training in Hamilton Rating Scale for Depression | -2.75 ± 4.5 | -7.5 ± 5.46 | -7.83 ± 4.49 | -2.29 ± 2.63 |
| centimeters per second | Aerobic Exercise | rTMS | AET+rTMS | Sham |
|---|---|---|---|---|
| Change From Baseline to Week 8 in Self-selected Walking Speed | 8.2 ± 9.52 | 7.7 ± 15.43 | 30.65 ± 20.24 | 2.19 ± 15.04 |
Collected over Throughout the 8 week intervention as well as during an 8 week follow-up period. Collected over a total of weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Aerobic Exercise | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) |
| rTMS | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| AET+rTMS | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) |
| Sham | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| Event | Aerobic Exercise | rTMS | AET+rTMS | Sham |
|---|---|---|---|---|
| fallMusculoskeletal and connective tissue disorders | 1/4 | 0/6 | 1/6 | 0/7 |
| Age, Categorical(Participants) | Aerobic Exercise | rTMS | AET+rTMS | Sham | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 4 | 3 | 4 | 6 | 17 |
| >=65 years | 0 | 3 | 2 | 1 | 6 |
| Sex: Female, Male(Participants) | Aerobic Exercise | rTMS | AET+rTMS | Sham | Total |
|---|---|---|---|---|---|
| Female | 3 | 4 | 3 | 4 | 14 |
| Male | 1 | 2 | 3 | 3 | 9 |
| Race (NIH/OMB)(Participants) | Aerobic Exercise | rTMS | AET+rTMS | Sham | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 3 | 1 | 3 | 3 | 10 |
| White | 1 | 5 | 3 | 4 | 13 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Aerobic Exercise | rTMS | AET+rTMS | Sham | Total |
|---|---|---|---|---|---|
| United States | 4 | 6 | 6 | 7 | 23 |
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Medical University of South Carolina