Actively Recruiting

Phase Not Applicable
Age: 21Years - 70Years
All Genders
NCT07050355

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

Led by Medical University of South Carolina · Updated on 2025-07-14

96

Participants Needed

2

Research Sites

252 weeks

Total Duration

On this page

Sponsors

M

Medical University of South Carolina

Lead Sponsor

N

National Institutes of Health (NIH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 21Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 21 to 70 years
  • Stroke occurred within the past 12 to 60 months
  • Positive screen for probable major depressive disorder (PHQ-9 > 10) and HAM-D17 score ≥ 14
  • Residual weakness in lower leg with Fugl-Meyer LE motor score < 34
  • Able to walk without assistance and no ankle-foot orthosis (AFO) at speeds from 0.2 to 1.0 m/s
  • Not currently on antidepressants or stable dosage for at least 4 weeks
  • HAM-D17 question #9 (suicide risk) score less than 2
  • Able and willing to provide informed consent
Not Eligible

You will not qualify if you...

  • Unable to walk at least 150 feet before stroke or have intermittent claudication while walking
  • History of congestive heart failure, unstable heart rhythms, hypertrophic cardiomyopathy, severe aortic stenosis, angina, or shortness of breath at rest or during daily activities
  • History of chronic obstructive pulmonary disease (COPD) or need for oxygen therapy
  • History of traumatic brain injury
  • Blindness or severe vision impairment
  • History of psychosis or other primary Axis I psychiatric disorders
  • Life expectancy less than 1 year
  • Severe arthritis or other problems limiting testing or training participation
  • History of deep vein thrombosis (DVT) or pulmonary embolism within 6 months
  • Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions
  • Severe high blood pressure with resting systolic > 200 mmHg or diastolic > 110 mmHg
  • Suicide attempt within last 2 years or assessed suicidal risk
  • History of seizures or currently taking anti-seizure medications
  • Currently enrolled in another motor recovery trial
  • Currently in behavioral treatment for depression
  • Exercising 2 or more times per week for at least 20 minutes
  • Contraindications to transcranial magnetic stimulation (TMS)
  • Pregnancy or contraindications to MRI

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Duke University School of Medicine

Durham, North Carolina, United States, 27710

Active, Not Recruiting

2

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

Actively Recruiting

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Research Team

C

Chris Gregory, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

TREATMENT

Number of Arms

3

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