Vagus Nerve Stimulation for Stroke

Recruiting at 1 trial location

Overseen By Heidi Schambra

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Must not be taking: Anticholinergics, Adrenergic blockers

Disqualifiers: Severe spasticity, Psychiatric disorders, Pregnancy, others

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

Compensation: Varies

Number of Visits: 6

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a small device that stimulates the vagus nerve can improve movement, thinking, and mood in individuals who had a stroke over a year ago. Participants will have the device implanted and will try two types of nerve stimulation—real (Vagus Nerve Stimulation Device) and fake (Sham VNS Device)—while performing arm and hand exercises. The researchers aim to determine if the device can strengthen brain pathways and enhance recovery. The trial seeks individuals who have experienced a stroke affecting one side of the brain and face challenges with arm movement. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance stroke recovery.

Will I have to stop taking my current medications?

The trial requires that you do not take any medications that interfere with vagus nerve stimulation, such as drugs that affect neurotransmitter action (like anticholinergics or adrenergic blockers). If you're on such medications, you may need to stop them to participate.

What prior data suggests that the Vagus Nerve Stimulation (VNS) device is safe for stroke patients?

Research shows that vagus nerve stimulation (VNS) is generally safe for people recovering from a stroke. Studies indicate that combining VNS with physical therapy can improve movement in the arms and hands. It is also considered a safe option for patients.

Participants who used VNS for stroke recovery continued to see improvements in movement and quality of life for over a year. This suggests that VNS is well-tolerated and does not cause major issues. Overall, VNS is unlikely to cause harmful side effects.

For those considering joining a trial involving VNS, current evidence supports its safety and potential benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Vagus Nerve Stimulation (VNS) for stroke recovery because it introduces a new way to enhance rehabilitation efforts. Unlike traditional stroke therapies that focus solely on physical and occupational therapy, VNS pairs these activities with electrical stimulation of the vagus nerve. This method is thought to boost brain plasticity, potentially leading to better recovery outcomes. By targeting the nervous system directly, VNS may offer a more effective and faster route to regaining motor function, which is a significant advancement over existing stroke rehabilitation techniques.

What evidence suggests that the Vagus Nerve Stimulation device is effective for stroke recovery?

This trial will evaluate the effectiveness of Vagus Nerve Stimulation (VNS) combined with rehabilitation for stroke recovery. Studies have shown that VNS with rehabilitation can help people regain arm movement after a stroke. Specifically, patients improved by an average of 7 points on the Fugl-Meyer scale. Research also suggests these improvements can last for at least a year, making daily activities easier and enhancing quality of life. Participants in this trial will receive either active VNS followed by sham VNS, or sham VNS followed by active VNS, to assess VNS's impact on recovery. VNS has consistently shown positive results in both clinical and early-stage studies, offering hope for those with movement difficulties after a stroke. Overall, VNS is a promising treatment for helping stroke survivors recover arm movement. ^{1 5 6 7 8}

Who Is on the Research Team?

Heidi Schambra, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for individuals who have had a stroke and are now in the chronic phase. They must be suitable candidates for having a small device implanted that stimulates the vagus nerve, which is part of the body's internal control system. Participants will undergo upper extremity rehabilitation as part of the study.

Inclusion Criteria

Ability to provide signed and dated informed consent form

I had a stroke in the upper part of my brain more than a year ago.

My arm's movement ability scores between 20 to 50 on a specific test.

Exclusion Criteria

Deficits in language or attention that interfere with study participation

Presence of any other implanted electrical stimulation device

Prior injury to vagus nerve

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Block 1

Participants receive either active VNS or sham VNS paired with upper extremity motor rehabilitation for 6 weeks

6 weeks

3 sessions per week (in-person)

Treatment Block 2

Participants crossover to receive the alternate condition (active VNS or sham VNS) paired with upper extremity motor rehabilitation for another 6 weeks

6 weeks

3 sessions per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sham VNS Device
• Upper Extremity Rehabilitation
• Vagus Nerve Stimulation (VNS) Device

Trial Overview The study tests if stimulating the vagus nerve with an implanted device can help recovery from stroke when paired with arm rehabilitation exercises. It compares real stimulation (active VNS) to fake stimulation (sham VNS) using a blinded crossover design, meaning participants will experience both conditions without knowing which one they're receiving at any time.

How Is the Trial Designed?

Group I: Sham VNS first, then Active VNS Experimental Treatment 3 Interventions

Patients will undergo two 6-week intervention blocks, receiving sham VNS first and active VNS second. Blocks consist of three 90-minute sessions per week with a licensed occupational therapist (OT). During these sessions, patients will perform rehabilitation training activities paired with sham VNS during the first block and paired with active VNS during the second block.

Group II: Active VNS first, then Sham VNS Experimental Treatment 3 Interventions

Patients will undergo two 6-week intervention blocks, receiving active VNS first and sham VNS second. Blocks consist of three 90-minute sessions per week with a licensed occupational therapist (OT). During these sessions, patients will perform rehabilitation training activities paired with active VNS during the first block and paired with sham VNS during the second block.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

University of Texas at Dallas

Collaborator

Published Research Related to This Trial

Vagus nerve stimulation (VNS), both invasive and non-invasive, significantly improves motor function and reduces motor impairment in stroke patients, based on a systematic review and meta-analysis of multiple studies.

The study found no significant difference in adverse events between VNS and control groups, suggesting that VNS is a safe intervention for enhancing recovery in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects and safety of vagus nerve stimulation on upper limb function in patients with stroke: a systematic review and meta-analysis. Abdullahi, A., Wong, TWL., Ng, SSM.[2023]

The Vivistim® Paired VNS™ System, approved by the FDA in 2021, is safe and effective for improving motor deficits in chronic ischemic stroke survivors, based on a pivotal trial involving 108 participants.

The study reported a lower rate of surgery-related adverse events compared to previous VNS implantations for epilepsy, with no serious adverse events linked to device stimulation, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vagus nerve stimulation paired with rehabilitation for stroke: Implantation experience from the VNS-REHAB trial. Liu, CY., Russin, J., Adelson, DP., et al.[2022]

In a study of 118 patients with refractory epilepsy who underwent vagus nerve stimulation (VNS), there was a significant average reduction in monthly seizure frequency of 55% over a mean follow-up of 33 months, indicating VNS is an effective long-term treatment option.

VNS was found to be safe, with only 15 patients reporting mild stimulation-related side effects, such as hoarseness or gagging, suggesting that it has a favorable safety profile in a large patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vagus nerve stimulation for refractory epilepsy: a transatlantic experience. Vonck, K., Thadani, V., Gilbert, K., et al.[2019]

In a retrospective study of 62 patients treated with vagus nerve stimulation (VNS) for epilepsy, only 6 patients experienced significant seizure reduction, indicating that while VNS can be beneficial, it may not be effective for the majority of patients.

Contrary to its reputation for low adverse effects, the study found that only 9 patients had no adverse effects, with some experiencing severe and even life-threatening complications, highlighting the need for careful monitoring throughout the treatment process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Vagus nerve stimulation therapy in epilepsy patients: long-term outcome and adverse effects: a retrospective analysis]. Carius, A., Wintermantel, A.[2022]

In a pilot trial with 20 stroke survivors, the closed-loop transcutaneous auricular vagus nerve stimulation (MAAVNS) paired with motor rehabilitation showed greater improvement in upper limb function compared to unpaired taVNS, with a higher effect size (Cohen's d = 0.63 vs. 0.30).

Participants receiving MAAVNS required significantly fewer stimulation pulses (36,070) than those receiving unpaired taVNS (45,000), suggesting that the timing and synchronization of stimulation with movement are critical for enhancing rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motor Activated Auricular Vagus Nerve Stimulation as a Potential Neuromodulation Approach for Post-Stroke Motor Rehabilitation: A Pilot Study. Badran, BW., Peng, X., Baker-Vogel, B., et al.[2023]

Vagus nerve stimulation (VNS) combined with rehabilitation was found to be safe and feasible for improving arm function in stroke patients, with all participants completing the therapy despite some serious adverse events related to surgery.

At 90 days post-therapy, patients receiving active VNS showed a significant improvement in upper limb function compared to the control group, with an 88% clinically meaningful response rate, suggesting that VNS may enhance rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vagus Nerve Stimulation Paired With Upper Limb Rehabilitation After Chronic Stroke. Kimberley, TJ., Pierce, D., Prudente, CN., et al.[2019]

Vagus nerve stimulation (VNS) is effective for treating refractory epilepsy and depression, but traditional methods involve surgical implantation, which carries risks such as infection and bradycardia.

New non-invasive VNS systems eliminate the need for surgery, improving safety and tolerability, and allowing patients to administer stimulation on demand, potentially expanding its use in various medical conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgically implanted and non-invasive vagus nerve stimulation: a review of efficacy, safety and tolerability. Ben-Menachem, E., Revesz, D., Simon, BJ., et al.[2022]

The VNS-REHAB trial aims to evaluate the safety and efficacy of vagus nerve stimulation (VNS) combined with upper limb rehabilitation in improving motor function in stroke patients, involving up to 120 participants with upper limb weakness due to stroke.

Preliminary studies suggest that VNS paired with rehabilitation leads to clinically meaningful improvements in motor function compared to rehabilitation alone, supporting the need for this larger pivotal trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol for a pivotal randomised study assessing vagus nerve stimulation during rehabilitation for improved upper limb motor function after stroke. Kimberley, TJ., Prudente, CN., Engineer, ND., et al.[2023]

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10870707/

Vagus nerve stimulation to improve post‐stroke motor function ... To assess the effectiveness and safety of vagus nerve stimulation as an add‐on treatment to rehabilitate people with post‐stroke motor function impairments and ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0303846725003269

Vagus nerve stimulation paired with rehabilitation for post- ... Vagus nerve stimulation (VNS) paired with rehabilitation has demonstrated the ability to aid in upper limb recovery after stroke. The Food and Drug ...

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

Efficacy and Safety of Vagus Nerve Stimulation on Upper ... VNS together with physical therapy increases upper limb motor recovery of stroke patients by an average of 7 points in the Fugl-Meyer scale, ...

5. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-025-01759-w

Mapping the role of vagus nerve stimulation in post-stroke arm ... VNS has demonstrated consistent efficacy in enhancing forelimb motor recovery in preclinical stroke models, with key subthemes including the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9283777/

Efficacy and Safety of Vagus Nerve Stimulation on Upper Limb ... VNS, together with physical rehabilitation, improves upper limb motor function in stroke patients. Additionally, VNS is a safe intervention.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0306452225003306

Review Vagus nerve stimulation in various stages of stroke ... This review synthesizes preclinical and clinical research on VNS, highlighting its mechanisms, applications, and challenges in stroke treatment.

8. nature.com nature.com/articles/s41598-023-42077-2

Effects and safety of vagus nerve stimulation on upper limb ... Therefore, VNS can serve as a means to reach centrally located neurological structures to help patients with stroke recover upper limb function.