What is the mechanism of action of this treatment?

Vagus Nerve Stimulation (VNS) is a promising treatment for stroke recovery that works by enhancing neural plasticity during rehabilitation exercises. VNS involves delivering brief electrical pulses to the vagus nerve, which activates neuromodulatory circuits that promote plasticity in the brain and spinal cord. This enhanced plasticity facilitates the reorganization and strengthening of neural connections, which is crucial for recovering motor and sensory functions lost due to stroke. For stroke patients, this means potentially improved outcomes in regaining independence and quality of life through more effective rehabilitation.

What side effects are associated with this type of intervention?

Vagus Nerve Stimulation (VNS) used in stroke rehabilitation is generally considered safe, with most side effects being mild and transient. Common side effects include hoarseness, throat pain, cough, and a tingling sensation in the neck. Serious adverse events are rare but can include changes in heart rate or blood pressure. Other neuromodulation techniques, such as transcranial magnetic stimulation (TMS), may cause mild side effects like lightheadedness, tingling, and tinnitus. Both VNS and TMS are promising for enhancing neural plasticity during rehabilitation, but larger trials are needed to fully understand their safety profiles.

What prior FDA approvals exist?

The FDA has approved various treatments for stroke, including tissue plasminogen activator (tPA) for acute ischemic stroke and mechanical thrombectomy devices. Vagus Nerve Stimulation (VNS), which enhances neural plasticity during rehabilitation, has shown promise in clinical trials for improving motor recovery post-stroke. While VNS is approved for other conditions like epilepsy and depression, its use in stroke rehabilitation is still under investigation, with initial studies indicating safety and efficacy in enhancing motor and sensory function recovery.

What other types of research exist?

Promising, novel alternatives to Vagus Nerve Stimulation for stroke patients include: 1) Transcutaneous supraorbital nerve stimulation, which has shown efficacy in reducing pain intensity and may have potential in enhancing neural plasticity. 2) Remote electrical neuromodulation, which involves nonpainful electrical skin stimulation and has demonstrated effectiveness in reducing acute pain, suggesting potential benefits in neural rehabilitation. 3) Transcranial magnetic stimulation (TMS), which has shown promise in reducing headache days and functional disability, indicating potential for enhancing neural plasticity during stroke rehabilitation.

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Behavioural Intervention

Vagus Nerve Stimulation for Stroke

N/A

Recruiting

Led By Rita Hamilton, DO

Research Sponsored by Baylor Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from week 1 through study follow-up, approximately two years after the final session of rehabilitation

Summary

This trial tests a treatment that sends small electrical pulses to a nerve in the neck during physical therapy for stroke patients. The goal is to help the brain and spinal cord form new connections, improving movement and sensation.

Who is the study for?

This trial is for adults aged 22-79 who've had a stroke at least one year ago and have some arm weakness. They must be able to follow the study plan, use birth control if capable of pregnancy, and meet surgical criteria for a nerve stimulation device implant.

What is being tested?

The trial tests a new wireless nerve stimulation device during rehab exercises to see if it helps recovery after stroke better than not using the device (placebo). Participants will receive brief pulses of vagus nerve stimulation aimed at improving motor and sensory functions.

What are the potential side effects?

Possible side effects include discomfort or pain where the device is implanted, changes in voice or throat sensations due to stimulating the vagus nerve, and typical risks associated with any surgical procedure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from week 1 through study follow-up, approximately two years after the final session of rehabilitation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from week 1 through study follow-up, approximately two years after the final session of rehabilitation

This trial's timeline: 3 weeks for screening, Varies for treatment, and from week 1 through study follow-up, approximately two years after the final session of rehabilitation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Adverse Events [Device Safety]

Secondary study objectives

Upper arm

Modified Rankin Scale

Range of Motion, Articular

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Immediate Start Vagus Nerve Stimulation groupExperimental Treatment1 Intervention

The Immediate Start VNS group will receive rehabilitation and active stimulation for 18 in-office sessions over the course of approximately six weeks during Phase 1. For Phase 2, all subjects will be provided with the option to participate in an open-label extension consisting of an additional 18 sessions of in-office rehabilitation with active VNS over the course of approximately six weeks. Additionally, participants may be provided with a system of rehabilitative devices to utilize at home.

Group II: Delayed Start Vagus Nerve Stimulation groupPlacebo Group1 Intervention

The Delayed Start VNS group will receive equivalent rehabilitation with placebo stimulation for 18 in-office sessions over the course of approximately six weeks during Phase 1. For Phase 2, all subjects will be provided with the option to participate in an open-label extension consisting of an additional 18 sessions of in-office rehabilitation with active VNS over the course of approximately six weeks. Additionally, participants may be provided with a system of rehabilitative devices to utilize at home.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Vagus Nerve Stimulation (VNS) is a promising treatment for stroke recovery that works by enhancing neural plasticity during rehabilitation exercises. VNS involves delivering brief electrical pulses to the vagus nerve, which activates neuromodulatory circuits that promote plasticity in the brain and spinal cord. This enhanced plasticity facilitates the reorganization and strengthening of neural connections, which is crucial for recovering motor and sensory functions lost due to stroke. For stroke patients, this means potentially improved outcomes in regaining independence and quality of life through more effective rehabilitation.