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New treatment option for Stroke
Official title Combining rTMS & Aerobic Exercise to Treat Depression and Improve Post-Stroke Walking
ClinicalTrials.gov ID: NCT07050355
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 70
You may be able to join if
- age 21-70
- stroke within the past 12 to 60 months
- screen positive for probable major depressive disorder (PHQ-9 \> 10) and HAM-D17 ≥ 14
- 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
You likely can't join if
- 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...
- 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
See the full eligibility criteria
- age 21-70
- stroke within the past 12 to 60 months
- screen positive for probable major depressive disorder (PHQ-9 \> 10) and HAM-D17 ≥ 14
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Durham, North Carolina, United States
- Charleston, South Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Durham, North Carolina, United States; Charleston, South Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.