Brain stimulation plus exercise may lift depression and boost walking after stroke
NCT ID NCT07050355
First seen Jul 14, 2026 · Last updated Aug 05, 2026 · Updated 3 times
Summary
This trial investigates whether combining repetitive transcranial magnetic stimulation (rTMS) with aerobic exercise can treat depression and improve walking in people who have had a stroke. Participants will receive either real or sham rTMS along with exercise sessions over 12 weeks. The study aims to see if treating depression helps the brain recover better, leading to greater functional gains.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- repetitive transcranial magnetic stimulation (rTMS) and aerobic exercise
- What this could lead to
- If successful, this combination could offer a new way to treat post-stroke depression while also helping people walk better.
- What could go wrong
- This is an early-phase trial with only 96 participants, so results may not apply to everyone. The treatments require multiple sessions and may not work for all individuals.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 96 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2024
- Expected to finish
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Aug 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion criteria: * 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 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Duke University School of Medicine
RECRUITINGDurham, North Carolina, 27710, United States
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Medical University of South Carolina
RECRUITINGCharleston, South Carolina, 29425, United States
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