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Search / Trial NCT07050355

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

Launched by MEDICAL UNIVERSITY OF SOUTH CAROLINA · Jun 24, 2025

Trial Information

Current as of July 05, 2025

Recruiting

Keywords

Stroke Rehabilitation Neuromodulation Tms Walking Exercise

ClinConnect Summary

This clinical trial is studying whether combining two treatments—repetitive transcranial magnetic stimulation (rTMS), a non-invasive brain stimulation, and aerobic exercise, like walking or cycling—can better help people who have depression after a stroke and improve their ability to walk. The goal is to see if adding exercise can boost the positive effects of rTMS on mood and walking recovery, since depression after stroke can make it harder for the brain to heal and for rehabilitation to work well.

People who may be eligible are adults aged 21 to 70 who had a stroke between 1 and 5 years ago, have signs of moderate to severe depression, and have some weakness in their legs but can still walk on their own at a slow to moderate pace. Participants should not be currently changing their antidepressant medications and must be physically able to take part in exercise. Those with serious heart, lung, or other health issues, or who are already exercising regularly, may not qualify. If you join, you can expect to receive rTMS treatment along with supervised aerobic exercise or a control activity, with neither you nor the researchers knowing which group you’re in to ensure fair results. This study is currently recruiting participants and aims to find better ways to treat post-stroke depression and help people improve their walking and overall recovery.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • age 21-70
  • 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.

About Medical University Of South Carolina

The Medical University of South Carolina (MUSC) is a leading academic health center dedicated to advancing medical research and improving patient care through innovative clinical trials. With a strong emphasis on translational medicine, MUSC leverages its extensive resources and expertise to facilitate groundbreaking studies across various medical disciplines. The institution is committed to fostering collaboration among researchers, healthcare professionals, and patients, ensuring that cutting-edge discoveries translate into effective treatments. As a pioneer in health education and research, MUSC plays a vital role in shaping the future of medicine and enhancing health outcomes in the community and beyond.

Locations

Charleston, South Carolina, United States

Durham, North Carolina, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported