NCT07050355 · Medical University of South Carolina
Combining rTMS & Aerobic Exercise to Treat Depression and Improve Post-Stroke Walking
(RESTORATION)
What this study is about
Investigators primary aim is to carry out a two-site, randomly assigned, where neither patients nor doctors know which treatment is given, 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).
View original scientific 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). 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
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- stroke within the past 12 to 60 months
- screen positive for probable major depressive disorder (PHQ-9 \> 10) and HAM-D17 ≥ 14
- 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.
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
- Durham, North Carolina
- Charleston, South Carolina
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 14, 2025 · Source of record for eligibility and locations