Aerobic Exercise and rTMS for Post-Stroke Depression
Combining rTMS & Aerobic Exercise to Treat Depression and Improve Post-Stroke Walking
Recruiting
N/AInterventional Study
StrokeDepression - Major Depressive DisorderWalking Impairment
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
21 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
96 (estimated)
Sponsor
Medical University of South Carolina · Other
Who this trial is looking for
This trial is looking for adults who have experienced a stroke and are dealing with depression. Participants will combine aerobic exercise with a non-invasive brain stimulation treatment to see if it helps improve their mood and walking ability.
Are You a Good Fit for This Trial?
Rules you outSevere hypertensionRecent suicide attemptHistory of seizures
You may be able to join if
I am over 21 years old.
I had a stroke at least 12 months ago.
I have symptoms of depression.
I can walk without help.
I have some weakness in my legs.
I have been stable without changes in antidepressant medications.
I understand the study and give my consent.
You may not be able to join if
I cannot walk at least 150 feet before my stroke.
I have serious heart conditions.
I have a history of lung problems or need oxygen.
I have a traumatic brain injury.
I have severe visual impairment or blindness.
I have a history of severe mental health issues.
I have a life expectancy of less than 1 year.
I have uncontrolled diabetes.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
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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…
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.
Trial Locations
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Eligibility Criteria
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 …
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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