NCT05691023Active, not recruiting
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)
Source: ClinicalTrials.gov · Last updated 9 Oct 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 50 (estimated)
- First submitted
- 10 Jan 2023
- Start date
- 1 Jun 2023
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- MicroTransponder Inc.
- Diseases
- Stroke
- NCT number
- NCT05691023
What you commit to
- Study type: Observational
- Planned participants: 50
- From 1 Jun 2023 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- Patient aged 18 or younger.
Other
- Pregnant women
Who the study is looking for
- Patient implanted or scheduled to be implanted commercially with the Vivistim System.
- Patient assessed as able to receive therapy in their home.
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Moxie OT Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
Related publications
- Vagus Nerve Stimulation Paired With Rehabilitation in the Home Environment for People With Chronic Post-Stroke Upper Limb Deficits: Preliminary Findings.Adv Rehabil Sci Pract · 2026 · PMID 42146328
This page is information, not medical advice. Discuss any trial with your doctor.