Combining rTMS & Aerobic Exercise to Treat Depression and Improve Post-Stroke Walking (NCT07050355) | Clinical Trial Compass
RecruitingNot Applicable
Combining rTMS & Aerobic Exercise to Treat Depression and Improve Post-Stroke Walking
United States96 participantsStarted 2024-11-01
Plain-language summary
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.
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
* age \>21
* stroke at least 12 months prior
* screen positive for depressive symptoms (PHQ-9 \> 5) and HAM-D17 ≥ 12
* residual paresis in the lower extremity (Fugl-Meyer LE motor score \<34)
* ability to walk without assistance and without an AFO at speeds ranging from 0.2-1.0 m/s
* not currently on antidepressant medications or no changes in antidepressant dosage in the last 4 weeks and clinically stable
* HAM-D17 question #9 regarding suicide \<2
* provision of informed consent. I
* All subjects who screen for major depressive disorder will be formally diagnosed by the project psychiatrist at each site using the Structured Clinical Interview for DSM5 (SCID-5).
* All subjects who meet criteria for the training portion must complete an exercise tolerance test and be cleared for participation by the study physician.
Exclusion criteria:
* 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
* blindness or severe visual impairment
* history of psychosis or other Axis I disorder that is primary
* life expectancy \<1 yr.
* severe arthritis or problems that limit participation in testing or training
* history of DVT or pulmonary embolism within 6 months
* uncontrolled …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Severity of depressive symptoms
Timeframe: baseline, after 2,4,6,8,10 and 12 weeks of treatment