NCT07050355Recruiting
Combining rTMS & Aerobic Exercise to Treat Depression and Improve Post-Stroke Walking
Combining rTMS & Aerobic Exercise to Treat Depression and Improve Post-Stroke Walking (RESTORATION)
Source: ClinicalTrials.gov · Last updated 4 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 96 (estimated)
- First submitted
- 3 Apr 2025
- Start date
- 1 Nov 2024
- Primary completion date
- 31 Aug 2029
- Lead sponsor
- Medical University of South Carolina
- Diseases
- Depression, Stroke
- NCT number
- NCT07050355
What you commit to
- Study type: Interventional
- Planned participants: 96
- From 1 Nov 2024 to the primary completion date, 31 Aug 2029
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- unable to ambulate at least 150 feet prior to stroke, or experienced intermittent claudication while walking
Other illness
- 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
- 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
- history of seizures or currently prescribed anti-seizure medications
Other
- life expectancy \<1 yr.
- severe arthritis or problems that limit participation in testing or training
- attempt of suicide in the last 2 years or suicidal risk assessed by SCID
- 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.
Who the study is looking for
- 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.
Age in the registry: 21 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Recruiting |
| Duke University School of Medicine Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.