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NCT03056287 · ClinicalTrials.gov registry record · NA
Exercise and Brain Stimulation for Post-stroke Depression
A NA study of Stroke, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- NA
- Development phase
- 23
- Enrollment target
- 1
- Study location
NCT03056287: Completed NA study of Stroke, sponsored by Medical University of South Carolina.
NCT03056287 is a NA study of Stroke that has completed, run by Medical University of South Carolina. The registered enrollment target is 23 participants, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03056287, a NA study of Stroke, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- NA
- Development phase
- 23 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
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 symp
Conditions Studied
Interventions
- BEHAVIORAL Aerobic exercise
- OTHER Repetitive transcranial magnetic stimulation
Study Locations (1)
South Carolina
- Medical University of South Carolina - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2016-01-01 |
| Est. Completion | 2019-12-31 |
| Phase | NA |
What the finished NCT03056287 record still lists
NCT03056287 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Stroke appearing as the primary indexed condition, and to 2 interventions - of which Aerobic exercise is the first listed.
NCT03056287 reports a single indexed study location in South Carolina.
Frequently Asked Questions
What is clinical trial NCT03056287 about?
NCT03056287 is a clinical study titled "Exercise and Brain Stimulation for Post-stroke Depression". 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 treatment...
What is the current status of trial NCT03056287?
This trial is currently completed. It is a NA study. The enrollment target is 23 participants. The study started on 2016-01-01. Estimated completion is 2019-12-31.
What conditions does trial NCT03056287 study?
This clinical trial studies the following conditions: Stroke.
What interventions are being tested in trial NCT03056287?
The interventions under investigation include: Aerobic exercise (BEHAVIORAL), Repetitive transcranial magnetic stimulation (OTHER).
Who is sponsoring clinical trial NCT03056287?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03056287 being conducted?
This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stroke
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03056287's enrollment target sits among peer trials
23 347th of 454 higher than 104 of 454 other Stroke trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stroke trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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