Clinical Research Directory

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

Sponsor: MicroTransponder Inc.

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.

Official title: 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)

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Interventions

Locations (1)