NCT05691023

VNS-REHAB At-Home - Post-Market Study for Using the Vivistim System® at Home

Vagus Nerve Stimulation (VNS) During Rehabilitation Using the Vivistim System®: Post-Market Study for Stroke Rehabilitation in a Home Environment for Subjects With Chronic Stroke (VNS-REHAB At-Home)

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: MicroTransponder Inc. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm post-market study of up to 150 participants, using up to 50 mobile therapists to conduct up to 36-hours at-home therapy. The study will assess at-home therapy implementation instead of an in-clinic therapy implementation for patients who are commercially implanted with the Vivistim System. Patients will be consented for eligibility if appropriate to be implanted with the Vivistim System per the indications for use (The MicroTransponder® Vivistim® Paired VNS™ System is intended to be used to stimulate the vagus nerve during rehabilitation therapy in order to reduce upper extremity motor deficits and improve motor function in chronic ischemic stroke patients with moderate to severe arm impairment.). Study participation includes receiving rehabilitation therapy paired with VNS, provided at the patient's home by a therapist, along with self-activated VNS. All subjects will be commercially implanted with the Vivistim System® after an ischemic stroke prior to Study treatment, although they may be consented prior to implant. It should be noted that the implant surgery is not part of the study.

Detailed description

This study has two distinct stages: Stage I (Acute), a treatment period of up to 18-weeks of Paired VNS™ for upper limb motor deficits - where patients receive VNS Paired with rehabilitation - provided at-home by a therapist along with self-activated VNS home-therapy on remaining days; Stage II (Long-term), a follow-up period of up to two years during which subjects continue self-activated VNS at-home using a magnet during therapist-prescribed functional tasks. The at-home therapy is a convenience for patients without having to drive or find transportation to a rehabilitation center, as well as reduce possible COVID-19 exposure in a setting with many people. Stage I of the VNS-REHAB At-Home study includes (ACUTE): * screening and consent * pre-therapy baseline evaluation (prior to the start of therapy) * Paired VNS™ for moderate to severe upper limb motor deficits will be provided in the patient's home by a therapist. Therapy length depends on scheduling between the therapist and subject for the subject's convenience. The intent is that 36 hours of in-home time will be provided over the study duration in two (2) or more visits per week. On days without the therapist-led rehabilitation, subjects will do therapist-prescribed functional activities on their own with magnet-activated VNS (self-activated VNS). * Therapy assessments: performed after 12, 24, and 36 hours of therapist time in the subject's home. Stage II includes (Long-Term): * Therapy assessments at 3, 12, and 24 months after completion of 36 hours of therapist visit duration. * Ongoing self-administration of at-home VNS during therapist-prescribed activities and rehabilitation outside of therapy visit duration. * subjects will exit the study after their two-year visit.

Conditions

• Ischemic Stroke
• Upper Extremity Problem

Interventions

Type	Name	Description
DEVICE	Vivistim System	Paired VNS during rehabilitation, facilitated by a rehab therapist in the subject's home (at-home treatment)

Timeline

• Start date: 2023-06-01
• Primary completion: 2026-12-31
• Completion: 2028-12-31
• First posted: 2023-01-19
• Last updated: 2025-10-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study