Vagus Nerve Stimulation for Stroke

N/A

Recruiting

Led By Jane Wigginton, MD

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

Awards & highlights

Study Summary

This trial will test whether vagus nerve stimulation, when paired with rehabilitation, is a safe and effective way to improve motor function in people who have had a stroke.

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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Adverse Events [Device Safety]

Secondary outcome measures

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.

Do I qualify?Apply below to find out