RecruitingNot ApplicableNCT07050355

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

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

Sponsor

Medical University of South Carolina

Enrollment

96 participants

Start Date

Nov 1, 2024

Study Type

INTERVENTIONAL

Conditions

Stroke Depression - Major Depressive Disorder Walking Impairment

Summary

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.

Eligibility

Min Age: 21 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study combines two treatments — repetitive transcranial magnetic stimulation (rTMS, a non-invasive brain stimulation technique) and aerobic exercise — to simultaneously treat depression and improve walking ability in people who have had a stroke. **You may be eligible if:** - You are between 21 and 70 years old - You had a stroke between 1 and 5 years ago - You screen positive for probable major depression (based on standard questionnaires) - You have some weakness in your leg after the stroke but can still walk without assistance - You are not currently on antidepressants, or your antidepressant dose has been stable for at least 4 weeks - You are not at high risk of suicide **You may NOT be eligible if:** - You have heart failure, unstable heart rhythm, or severe angina - You have COPD or oxygen dependence - You have had a previous traumatic brain injury - You have a history of seizures or take anti-seizure medication - You are currently enrolled in another motor recovery trial or behavioral depression treatment - You already exercise 2 or more times per week - You have contraindications to TMS (brain stimulation) or MRI - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICErTMS

Subjects will undergo rTMS to the left dorsolateral prefrontal region as a treatment for depression. Treatment will be performed three times per week for 12 weeks (36 sessions) . We will use a standard resting motor threshold (rMT) determination from unaffected abductor pollicis brevis. Treatments will be delivered at the EEG coordinate for F3 (approximating the left DLPFC) and will be found using the Beam-F3 method. A total of 5000 pulses/session will be delivered at 10Hz with an intensity of 120% of rMT.

BEHAVIORALAEx

The goal of AEx will be 20 minutes of continuous walking at an intensity of \~70% of heart rate reserve (HRR calculated via the Karvonen method). The desired intensity will be achieved by a combination of increasing treadmill speed and incline. Rest breaks will be allowed as needed during training with the goal of progressing to 20 minutes of continuous walking.