Combining rTMS and aerobic exercise to reduce depression and improve walking after stroke
Official title: Combining rTMS & Aerobic Exercise to Treat Depression and Improve Post-Stroke Walking (RESTORATION)
Run by Medical University of South Carolina · NCT07050355 · Data updated 2026-11-12
This study will try combining repetitive transcranial magnetic stimulation (rTMS) with treadmill aerobic exercise to see if it reduces depression and improves walking in people 12–60 months after a stroke.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 21 Years and up |
| Sex | All |
| Enrollment | 96 (estimated) |
| Sponsor | Medical University of South Carolina Academic / other |
| Locations | 2 sites (Durham, North Carolina and 1 other locations) |
| Status | Recruiting |
| Started | November 1, 2024 |
| Main results expected | August 31, 2029 |
| Study ends | August 31, 2029 |
| Registry record updated | August 4, 2026 |
| Trial ID | NCT07050355 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 21–70 who had a stroke 12–60 months ago, screen positive for probable major depressive disorder (PHQ-9 >10 and HAM-D17 ≥14), have residual lower‑extremity weakness but can walk unassisted at 0.2–1.0 m/s, and are not changing antidepressant medications would be ideal candidates.
✕Probably not a fit
People with unstable cardiac or severe pulmonary disease, a history of traumatic brain injury or psychosis, severe visual impairment, inability to ambulate prior to stroke, or active high suicide risk are unlikely to benefit or may be excluded for safety.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a two-site, randomized, double-blind, sham-controlled phase II trial enrolling 96 participants 12–60 months after stroke to receive 12 weeks of treatment delivered three times per week. Participants will be assigned to receive rTMS, treadmill aerobic exercise (AEx), or the combination (rTMS+AEx) with symptom and function assessments every two weeks during treatment and at 12- and 24-week follow-ups. Primary outcomes are depressive symptoms (HAM-D17) and walking capacity (6MWT); secondary outcomes include community walking (steps/day) and quality of life (Stroke Impact Scale). The protocol also includes exploratory biomarker studies using PAS-induced plasticity testing and MRI measures of cortical grey matter thickness.
Why it matters
Potential benefit: If successful, combining rTMS with aerobic exercise could reduce depressive symptoms and produce larger, more durable improvements in walking and daily function after stroke.
How similar studies have gone: rTMS and aerobic exercise each have evidence of antidepressant benefit in non-stroke populations and some small studies support rTMS in post-stroke depression, but the specific combination in PSD has not been widely tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 diabetes with recent weight loss, diabetic coma, or frequent insulin reactions * severe hypertension with systolic \>200 mmHg and diastolic \>110 mmHg at rest * attempt of suicide in the last 2 years or suicidal risk assessed by SCID * history of seizures or currently prescribed anti-seizure medications * current enrollment in a trial to enhance motor recovery * currently participating in behavioral treatment for depression * currently exercising ≥ 2 times per week (≥20 minutes) * contraindications to TMS * pregnancy or other contraindications to MRI.
Where it's running
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Duke University School of Medicine
Durham, North Carolina, United States Recruiting -
Medical University of South Carolina
Charleston, South Carolina, United States Recruiting
Study contacts
- Study coordinator: Chris Gregory, PhD
- Email: gregoryc@musc.edu
- Phone: (843)792-1078
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.