Transcranial Magnetic Stimulation for Stroke

(VERIFY Trial)

Recruiting at 45 trial locations

Overseen By Kalli Beasley, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Cincinnati

Must not be taking: Anti-epileptics

Disqualifiers: UE injury, Legally blind, Pregnancy, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

657 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how well certain signs, called biomarkers, can predict arm and hand recovery after a stroke. It focuses on two types of strokes: ischemic (caused by a blockage) and hemorrhagic (caused by bleeding). The study employs a technique called Transcranial Magnetic Stimulation (TMS), which uses magnetic fields to stimulate nerve cells in the brain. Individuals who have experienced a stroke on one side of the brain and currently have difficulty moving their arm or hand might be suitable candidates. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance stroke recovery strategies.

Do I need to stop my current medications to join 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 Transcranial Magnetic Stimulation (TMS) is safe for stroke patients?

Research has shown that transcranial magnetic stimulation (TMS) is generally safe and easy to manage. TMS is a noninvasive method, meaning it doesn't involve surgery or entering the body. It is also painless and convenient for patients. For those recovering from a stroke, repetitive TMS (rTMS) has been found to improve movement and thinking abilities. Most people experience only mild side effects, if any, such as slight headaches or scalp discomfort. Overall, TMS is considered a safe option for stroke recovery with minimal risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Transcranial Magnetic Stimulation (TMS) is unique because it offers a non-invasive way to potentially improve recovery outcomes after a stroke. Unlike standard treatments, such as medication and physical therapy, TMS uses magnetic fields to stimulate nerve cells in the brain, which may enhance neural connections and promote healing. Researchers are excited about TMS because it targets the brain directly and could lead to faster and more effective recovery for stroke patients.

What evidence suggests that Transcranial Magnetic Stimulation (TMS) is effective for stroke patients?

Research shows that transcranial magnetic stimulation (TMS) can enhance movement abilities after a stroke. Studies have found that TMS boosts grip strength and eases daily activities, both crucial for stroke recovery. In this trial, ischemic and hemorrhagic stroke patients will receive TMS, including variations like repetitive TMS (rTMS), noted for its potential to aid recovery of both movement and cognitive skills. Additionally, research confirms that TMS can address movement problems and cognitive difficulties in stroke survivors. Overall, evidence suggests that TMS could improve recovery outcomes for stroke patients. ^{1 2 4 6 7}

Who Is on the Research Team?

Pooja Khatri, MD

Principal Investigator

Yale University

Steve Cramer, MD

Principal Investigator

University of California, Los Angeles

Cathy Stinear, PhD

Principal Investigator

University of Auckland, New Zealand

Achala Vagal, MD

Principal Investigator

University of Cincinnati

Are You a Good Fit for This Trial?

Inclusion Criteria

Unilateral stroke due to ischemia or intracerebral hemorrhage

Motor deficits in the acutely affected UE, defined as a Shoulder Abduction and Finger Extension (SAFE) score ≤ 8 out of 10 points (i.e., excluding full or nearly full motor strength in both shoulder abduction and finger extension) within 48 to 96 hours of stroke onset (or time last known well).

Provision of signed and dated informed consent form within 48 to 96 hours of stroke onset (or time last known well).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline clinical, TMS, and MRI measures are collected to assess CMS integrity and CST injury

1 week

1 visit (in-person)

Follow-up

Participants are monitored for 90-day UE motor outcomes using various assessments

90 days

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Transcranial Magnetic Stimulation (TMS)

How Is the Trial Designed?

Group I: Ischemic & Hemorrhagic stroke patients Experimental Treatment 1 Intervention

up to 657 stroke patients

Who Is Running the Clinical Trial?

University of Cincinnati

Lead Sponsor

Trials

442

Recruited

639,000+

University of California, Los Angeles

Collaborator

Trials

1,594

Recruited

10,430,000+

University of Auckland, New Zealand

Collaborator

Trials

82

Recruited

372,000+

Medical University of South Carolina

Collaborator

Trials

994

Recruited

7,408,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12401453/

A meta-analysis of the effects of transcranial magnetic ... The LF-HF rTMS regimen combined with 2 kinds of magnetic stimulation has the best ranking in improving grip strength, activities of daily living ...

2. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.123.043159

Evidence of rTMS for Motor or Cognitive Stroke Recovery Repetitive transcranial magnetic stimulation holds the potential to benefit a range of motor and cognitive outcomes after stroke.

3. eurjmedres.biomedcentral.com eurjmedres.biomedcentral.com/articles/10.1186/s40001-025-02714-0

Research on transcranial magnetic stimulation for stroke ... Numerous studies have confirmed that TMS is effective for addressing motor dysfunction, swallowing disorders, cognitive impairment, and ...

4. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2025.1650216/full

Comparison of repetitive transcranial magnetic stimulation ... No significant difference emerged between rTMS and iTBS efficacy (p > 0.05). Conclusion: rTMS and iTBS equivalently improve post-stroke ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1094715924006652

Repetitive Transcranial Magnetic Stimulation for Motor ... Repetitive transcranial magnetic stimulation (rTMS) has shown promising results in enhancing motor recovery after stroke, but nuances regarding its use, ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04562415

The Effect Of Transcranial Magnetic Stimulation In Patients ... This study is aimed to investigate the effect of continuous theta burst stimulation (cTBS) and low frequency repetitive transcranial magnetic stimulation (rTMS) ...

7. frontiersin.org frontiersin.org/journals/immunology/articles/10.3389/fimmu.2023.1197422/full

Repetitive transcranial magnetic stimulation for stroke ... In this review, we would like to summarized the clinical benefits of rTMS for stroke rehabilitation, including improvements of motor impairment, dysphagia, ...