rTMS and Aerobic Exercise for Post-Stroke Depression and Walking

This study is looking at how combining rTMS (repetitive transcranial magnetic stimulation), a treatment for depression that uses magnetic pulses, with aerobic exercise (AEx), like walking on a treadmill, might help people who have depression and walking problems after a stroke. The researchers want to see if AEx can make rTMS work even better for depression. You might be able to join if you are 21-70 years old, had a stroke 12-60 months ago, have probable major depressive disorder, and have some weakness in your leg but can still walk without help. The main goal is to see how much your depressive symptoms improve over 12 weeks of treatment. The current recruitment status is unclear.

Study design
This is a randomized, double-blind, sham-controlled study across two sites, planning to enroll 96 participants. Participants will be assigned to receive rTMS, aerobic exercise, or both.
What's involved
You would receive treatments three times per week for 12 weeks. Assessments of depression and walking capacity will be done every two weeks during treatment.
Compensation
Not stated in the trial record.
Follow-up
Assessments will continue for 12 and 24 weeks after treatment ends to see how long the effects last.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07050355

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

Recruiting
NAAges 21+InterventionalTreatment
Medical University of South Carolina
~96 participants
Updated 2026-08-04 on ClinicalTrials.gov
What's tested:rTMSAEx

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Severity of depressive symptoms
Measured over baseline, after 2,4,6,8,10 and 12 weeks of treatment
Stroke
Depression - Major Depressive Disorder
Walking Impairment

NCT07050355

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Duke University School of Medicine

    Durham, North Carolinastudy coordinator listed

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolinastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

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Eligibility criteria

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
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.
  • Severity of depressive symptomsbaseline, after 2,4,6,8,10 and 12 weeks of treatment

    The Hamilton Depression Rating Scale (HAM-D17) is the gold-standard for clinical trial outcomes and samples a broad array of depressive symptoms. Critically, the rater administering the HAM-D17 will be clinically trained and will blinded to all other aspects of the study. For this trial, depression severity will be classified as moderate (HAM-D17 = 14-19) or severe (HAM-D = 20-25) for the purpose of stratification and diagnosed upon enrollment using the Structured Clinical Interview for Depression according to the Diagnostic \& Statistical Manual of Mental Disorders, 5th Edition (DSM-V).