Vagus Nerve Stimulation for Stroke

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Intracerebral hemorrhage, Psychosis, Substance abuse, others

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

Compensation: Varies

Number of Visits: 18

Duration: 12 months

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to improve walking after a stroke. It combines vagus nerve stimulation, which sends mild pulses to a nerve in the neck, with specialized training to enhance leg movement. The researchers aim to determine if this method is safe and effective for individuals who experienced an ischemic stroke (caused by a blocked blood vessel) at least six months ago and have difficulty walking quickly. Candidates may qualify if they have had a stroke affecting walking speed and can attend in-person rehab sessions. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance recovery options for stroke survivors.

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 vagus nerve stimulation with mobility training is safe for individuals with chronic ischemic stroke?

Research has shown that using vagus nerve stimulation (VNS) with rehabilitation is generally safe for individuals who have experienced a long-term stroke due to a blocked blood vessel. In earlier studies, participants who received VNS demonstrated improved movement abilities without major safety concerns. For instance, one study found VNS to be safe and practical for those with post-stroke movement issues. Another study showed that VNS, when combined with therapy, led to noticeable improvements in many patients, with benefits lasting up to 90 days. Overall, these findings suggest that VNS is well-tolerated and could be a promising method to enhance movement after a stroke. ^{1 2 3 4}

Why are researchers excited about this trial?

Vagus Nerve Stimulation (VNS) with Mobility Training is unique because it combines nerve stimulation with physical rehabilitation to enhance recovery after a stroke. Unlike standard treatments for chronic ischemic stroke, which typically focus on medication and physical therapy alone, VNS directly stimulates the vagus nerve to potentially improve neuroplasticity, helping the brain rewire itself more effectively. Researchers are excited about this approach because it offers a novel way to boost the brain's recovery processes, potentially leading to better outcomes for stroke survivors.

What evidence suggests that vagus nerve stimulation with mobility training is effective for improving lower extremity function in chronic ischemic stroke?

Research has shown that stimulating the vagus nerve (VNS) along with movement exercises can help people with long-term effects from a stroke improve their motor skills. In earlier studies, participants who received VNS during rehabilitation showed significant improvements in using their arms and hands. On average, 66.2% of participants responded well to the therapy, demonstrating noticeable progress in their motor skills. These improvements persisted even a year after the treatment. In this trial, participants with chronic ischemic stroke will receive a combination of VNS and mobility training, suggesting that VNS might also enhance leg movement and walking in stroke survivors. ^{1 3 5 6 7}

Who Is on the Research Team?

Rushna Ali, MD

Principal Investigator

Mayo Clinic

Muhib Khan, MD, MBBS

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults over 18 who had an ischemic stroke at least 6 months ago and are now experiencing walking difficulties, with a gait speed below 0.8 m/s. It's not suitable for those with psychosis or substance abuse history, other neurological disorders like Parkinson's or ALS, severe pre-stroke disabilities, or anyone unable to attend rehab sessions.

Inclusion Criteria

I had a stroke more than 6 months ago.

Provision of informed consent

I am 18 years old or older.

Exclusion Criteria

Active or prior psychosis or substance abuse within two years

I have had a bleeding stroke.

I do not have neurological conditions like Parkinson's, ALS, MS, dementia, or major head trauma affecting my movement.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive vagus nerve stimulation paired with mobility training

12 months

18 therapy sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Vagus Nerve Stimulation (VNS) with Mobility Training

Trial Overview

The study tests if combining vagus nerve stimulation (VNS) with mobility training can help improve walking ability in people who have had a chronic ischemic stroke. The safety and effectiveness of this combination therapy will be assessed.

How Is the Trial Designed?

Group I: Chronic ischemic stroke Experimental Treatment 1 Intervention

Participants with chronic ischemic stroke will be treated with a combination of vagus nerve stimulation and mobility training.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1.

ahajournals.org

ahajournals.org/doi/10.1161/STROKEAHA.124.050479

Long-Term Outcomes of Vagus Nerve Stimulation Paired ...

People treated with paired vagus nerve stimulation maintained improvements in UE impairment, activity, participation, and quality-of-life measures at 1 year.

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/33894832/

Vagus nerve stimulation paired with rehabilitation for upper ...

Background: Long-term loss of arm function after ischaemic stroke is common and might be improved by vagus nerve stimulation paired with ...

3.

nervesadmin.com

nervesadmin.com/index.php?option=com_dailyplanetblog&view=entry&year=2025&month=07&day=20&id=111:chronic-stroke-survivors-demonstrate-long-term-improvement-in-motor-impairment-with-vivistim-therapy

Chronic Stroke Survivors Demonstrate Long-Term ...

Average improvement from baseline was FMA-UE: 5.23; WMFT: 0.50 · 66.2% of the 74 participants responded positively to Paired VNS™ Therapy ...

4.

consultqd.clevelandclinic.org

consultqd.clevelandclinic.org/vagal-nerve-stimulation-after-stroke

Vagal Nerve Stimulation for Functional Recovery After Stroke

This combination intervention offers new hope for more meaningful recovery after ischemic stroke, particularly in upper extremity function. Its ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05694663

Study Details | NCT05694663 | Vagal Nerve Stimulation in ...

Vagal Nerve Stimulation is a novel proven therapy for patients with chronic ischemic stroke. The primary objective of this registry is to assess the safety ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/30355189/

Vagus Nerve Stimulation Paired With Upper Limb ...

Conclusions- VNS paired with rehabilitation was acceptably safe and feasible in participants with upper limb motor deficit after chronic ischemic stroke. A ...

7.

frontiersin.org

frontiersin.org/journals/neurology/articles/10.3389/fneur.2022.889953/full

Efficacy and Safety of Vagus Nerve Stimulation on Upper ...

In some of the reviewed studies with implanted VNS, a clinically significant response was found in 47 to 88% of patients up to 90 days after the ...