rTMS + Aerobic Exercise for Stroke and Depression
(RESTORATION Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether combining aerobic exercise with repetitive transcranial magnetic stimulation (rTMS) can more effectively treat depression in stroke survivors. Both treatments have been shown to alleviate depression, but researchers aim to determine if their combined use offers greater benefits for stroke patients. The goal is to reduce depression, potentially aiding in stroke recovery. Individuals who experienced a stroke in the last 1-5 years, have ongoing depression, and can walk unaided may be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could improve recovery options for stroke survivors.
Do I have to stop taking my current medications for the trial?
The trial requires that you are not currently on antidepressant medications or have not changed your antidepressant dosage in the last 4 weeks. If you are on other medications, the protocol does not specify whether you need to stop them.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that combining repetitive transcranial magnetic stimulation (rTMS) with aerobic exercise is safe and well-tolerated for people who have had a stroke and experience mild depression. Studies have found that this combination treatment does not cause major side effects.
rTMS alone has been safely used to treat depression, and aerobic exercise is well-known for its mental health benefits. Together, these treatments appear effective in alleviating depression after a stroke without causing significant harm.12345Why are researchers excited about this trial?
Researchers are excited about the combination of repetitive transcranial magnetic stimulation (rTMS) and aerobic exercise for treating stroke and depression because it offers a unique dual approach. Most treatments for these conditions involve medication or traditional physical therapy, but this method combines brain stimulation with physical activity. rTMS uses magnetic fields to stimulate nerve cells in the brain, potentially improving mood and cognitive function. Coupled with aerobic exercise, which is known to boost overall brain health and recovery post-stroke, this treatment could enhance both physical and mental rehabilitation in a synergistic way. This novel approach aims to maximize recovery by tackling both the brain and body simultaneously.
What evidence suggests that this trial's treatments could be effective for post-stroke depression?
Research has shown that repetitive transcranial magnetic stimulation (rTMS) combined with aerobic exercise may help treat depression after a stroke. In this trial, participants will be assigned to different treatment arms: one receiving both rTMS and aerobic exercise, another receiving only rTMS, and a third receiving only aerobic exercise. In one study, many participants experienced a 50% or greater improvement in depression symptoms. rTMS alone has effectively reduced depression and addressed some stroke-related brain issues. Aerobic exercise is also known to alleviate depression, so combining it with rTMS might enhance these benefits. Overall, evidence suggests that this combined approach could effectively reduce depression symptoms in stroke survivors.12678
Are You a Good Fit for This Trial?
This trial is for adults aged 21-70 who have had a stroke within the last 1 to 5 years, can walk unassisted at certain speeds, and are experiencing major depression but not on antidepressants or haven't changed their dosage recently. Exclusions include life-threatening conditions, severe heart issues, visual impairments, history of psychosis or suicide attempts, uncontrolled diabetes, seizures, frequent exercise habits (>2 times per week), and other specific health concerns.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive rTMS, treadmill aerobic exercise, or both for 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Combining rTMS & Aerobic Exercise
Trial Overview
The study tests if aerobic exercise (AEx) can boost the anti-depressant effects of repetitive transcranial magnetic stimulation (rTMS) in individuals with post-stroke depression. It's a phase II trial across two sites where participants are randomly assigned to real or sham treatments in a double-blind setup to see if this combination helps improve mood and stroke recovery better than rTMS alone.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
combination of repetitive transcranial magnetic stimulation and treadmill aerobic exercise
treadmill aerobic exercise
repetitive transcranial magnetic stimulation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medical University of South Carolina
Lead Sponsor
Duke University
Collaborator
National Institutes of Health (NIH)
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Citations
rTMS and aerobic exercise in post-stroke depression: a ...
Depressive symptoms improved in all three participants, with all demonstrating response (≥50% improvement in symptoms) and likely remission. All ...
Combining rTMS & Aerobic Exercise to Treat Depression ...
This project will determine whether aerobic exercise enhances the anti-depressant benefits rTMS in individuals with PSD through a two-site, ...
Systematic review Efficacy and Safety of High-Frequency ...
The study results indicated that HF-rTMS had significantly positive effects on depression in patients with stroke.
Four Comparative Effectiveness of Rehabilitation Methods ...
The combination of SR with rTMS is effective for enhancing cognitive function, whereas CR with rTMS is superior in alleviating negative emotions ...
Repetitive transcranial magnetic stimulation for post-stroke ...
The findings indicate that rTMS not only reduced depressive symptoms but also somewhat reduced neurological deficits and overall functional ...
Repetitive transcranial magnetic stimulation for post-stroke ...
Transcranial magnetic stimulation has also been demonstrated to be effective in the treatment of depression. Numerous studies have demonstrated ...
Feasibility of performing a multi-arm clinical trial examining ...
Feasibility of performing a multi-arm clinical trial examining the novel combination of repetitive transcranial magnetic stimulation and aerobic exercise for ...
Combining aerobic exercise and repetitive transcranial ...
Two non-pharmacological approaches with significant and direct impacts on neuroplasticity are aerobic exercise and repetitive transcranial magnetic stimulation.
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