Combining Brain Stimulation and Exercise for Post-Stroke Depression and Walking

Trial details

Who runs it

Medical University of South Carolina

Trial code

NCT07050355

Record updated

4 August 2026

Original description

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).Read full original descriptionShow less

Combining rTMS & Aerobic Exercise to Treat Depression and Improve Post-Stroke Walking (RESTORATION)

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.

Inclusion: 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: 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; 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; 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.

ClinicalTrials.gov NCT07050355