rTMS + Aerobic Exercise for Stroke and Depression

(RESTORATION Trial)

Recruiting at 1 trial location

Overseen By Chris Gregory, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Must not be taking: Antidepressants, Anti-seizure

Disqualifiers: Heart failure, COPD, Psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 15

Duration: 12 weeks

96 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{1 2 6 7 8}

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

Screen positive for probable major depressive disorder (PHQ-9 > 10) and HAM-D17 ≥ 14

I am between 21 and 70 years old.

I have weakness in my leg (scored below 34 on a specific test).

Exclusion Criteria

Life expectancy <1 yr

Current enrollment in a trial to enhance motor recovery

Pregnancy or other contraindications to MRI

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive rTMS, treadmill aerobic exercise, or both for 12 weeks

12 weeks

3 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

Assessments at 12 and 24 weeks post-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?

Group I: rTMS + AEx Experimental Treatment 2 Interventions

combination of repetitive transcranial magnetic stimulation and treadmill aerobic exercise

Group II: AEx Active Control 1 Intervention

treadmill aerobic exercise

Group III: rTMS Active Control 1 Intervention

repetitive transcranial magnetic stimulation

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5801693/

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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07050355?term=heart+disease

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, ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003999319302424

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.

4. archives-pmr.org archives-pmr.org/article/S0003-9993(25)00662-8/abstract

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 ...

5. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2023.930558/full

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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10061017/

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 ...

7. tandfonline.com tandfonline.com/doi/abs/10.1080/10749357.2023.2165258

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 ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0149763417300957

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.