rTMS for Stroke Apathy

Overseen By Lisa McTeague, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Medical University of South Carolina

Disqualifiers: Dementia, Aphasia, Seizure disorder, others

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

Compensation: Varies

Number of Visits: 6

Duration: 2 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist individuals experiencing apathy, characterized by a lack of motivation and withdrawal, following a stroke. Researchers aim to determine if repetitive transcranial magnetic stimulation (rTMS) can safely and effectively alleviate these symptoms. Participants will receive either the active rTMS treatment or a sham (placebo) version for comparison. This trial may suit those who have experienced apathy for at least six months post-stroke and can complete cognitive tasks. As a Phase 1 and Phase 2 trial, the research focuses on understanding how rTMS functions in individuals and assessing its effectiveness in an initial, smaller group.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this rTMS treatment is safe for stroke apathy?

Research has shown that accelerated repetitive transcranial magnetic stimulation (rTMS) is generally safe and well-tolerated for stroke patients experiencing apathy. One study found that this treatment did not cause any serious side effects. Another study showed that patients felt better for at least three months after receiving accelerated rTMS. Early findings also suggest that this treatment can quickly boost motivation in people who have had a stroke. Overall, these studies indicate that accelerated rTMS is a promising and safe option for improving apathy during stroke recovery. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for stroke apathy?

Researchers are excited about accelerated repetitive transcranial magnetic stimulation (rTMS) for treating stroke-related apathy because it offers a novel approach by using magnetic fields to stimulate nerve cells in the brain. Unlike traditional treatments for apathy, which often involve medications like antidepressants, rTMS directly targets specific brain regions linked to motivation and mood. This method is non-invasive and has the potential to show quicker improvements in symptoms compared to standard pharmacological treatments. Additionally, the use of a sham comparator in trials helps ensure that any observed benefits are due to the treatment itself, boosting confidence in its efficacy.

What evidence suggests that accelerated rTMS is effective for apathy after a stroke?

This trial will compare the effects of active accelerated rTMS with a sham treatment for stroke-related apathy. Studies have shown that repetitive transcranial magnetic stimulation (rTMS) can improve symptoms of apathy in stroke survivors. Research indicates that rTMS can reduce depression symptoms, often linked to apathy, with improvements lasting at least three months. Some evidence also suggests that rTMS may help with apathy across various conditions, including stroke. Although no treatments are specifically approved for stroke-related apathy, early findings suggest that rTMS is a promising option to explore. ^{1 2 3 4 5}

Who Is on the Research Team?

Parneet Grewal, PhD

Principal Investigator

Medical University of South Carolina

Lisa McTeague, PhD

Principal Investigator

Medical University of South Carolina

Kevin Caulfield, PhD

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for individuals who have experienced a stroke and are now facing apathy, which includes loss of motivation and withdrawal from activities they once enjoyed. There's no current FDA-approved treatment for this condition.

Inclusion Criteria

I have someone who knows about my daily and mental health and sees me weekly.

I had a stroke in either side of my brain over 6 months ago.

I or my caregiver have noticed significant lack of interest or motivation.

Exclusion Criteria

I have had a specific type of brain bleed without a stroke or another type of brain bleed.

I do not have any brain disorders affecting my movement or thinking.

I do not have implants or devices that could be affected by MRI or TMS.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive accelerated iTBS-rTMS treatment for post-stroke apathy over 6 days within 2 weeks, totaling 72 sessions and 43,200 pulses.

2 weeks

6 days of treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at baseline, immediately post-treatment, and 1-month follow-up.

4 weeks

Weekly assessments

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Accelerated rTMS

Trial Overview The study tests repetitive transcranial magnetic stimulation (rTMS) using the Brainsight Neuronavigation System and MagVenture MagPro TMS System to stimulate the medial prefrontal cortex. It aims to determine if rTMS is safe, comfortable, and effective in treating post-stroke apathy.

How Is the Trial Designed?

Group I: Active TMS Experimental Treatment 2 Interventions

This group will receive active accelereated iTBS-rTMS

Group II: Sham TMS Placebo Group 2 Interventions

This group will receive sham accelerated iTBS-rTMS

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05878457

NCT05878457 | Accelerated rTMS for Post-Stroke Apathy This pilot study will investigate the safety, feasibility, tolerability, and preliminary efficacy of accelerated high-dose repetitive transcranial magnetic ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10239808/

Repetitive transcranial magnetic stimulation for stroke ... The results revealed that HAMD of PSD patients remarkably reduced after the accelerated rTMS, which maintained for 3 months. Besides, no ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07113067

Accelerated rTMS vs. Sham for Stroke Apathy There are currently no FDA-approved treatments to help with apathy, and other services like therapy may be difficult to access for people who have had a stroke.

4. brainstimjrnl.com brainstimjrnl.com/article/S1935-861X(24)00683-1/fulltext

Targeting Motivation in Post Stroke Apathy using Repetitive ... Primary outcomes include safety, feasibility and acceptability, as well as changes in apathy, neuropsychiatric symptoms, quality of life and caregiver burnout.

5. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2023.1259481/full

Repetitive transcranial magnetic stimulation for apathy in ... Limited evidence suggests that rTMS intervention may have the potential to modify apathy among patients with AD, PPA, MCI and chronic stroke, but less so in PD ...