Combining rTMS & Aerobic Exercise to Treat Depression and Improve Post-Stroke Walking
Recruiting · NCT07050355 · Interventional (participants receive a specific treatment) · Lead sponsor: Medical University of South Carolina
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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.
Where it is running
2 locations listed across 2 US states.
- Duke University School of Medicine - Durham, North Carolina, United States
- Medical University of South Carolina - Charleston, South Carolina, United States