VNS-REHAB At-Home - Post-Market Study for Using the Vivistim System® at Home (AT-HOME)

October 7, 2025 updated by: MicroTransponder Inc.

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)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60618
        • Moxie OT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects implanted commercially with the Vivistim System (patients who have upper extremity motor deficits after an ischemic stroke and who are trying to improve their motor function. These patients have moderate to severe arm impairment.

Description

Inclusion Criteria:

  • Patient implanted or scheduled to be implanted commercially with the Vivistim System.
  • Patient assessed as able to receive therapy in their home.

Exclusion Criteria:

  • Patient aged 18 or younger.
  • Pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Vivistim
All subjects will be commercially implanted with the Vivistim System® after an ischemic stroke prior to Study treatment.
Device: Vivistim System
Paired VNS during rehabilitation, facilitated by a rehab therapist in the subject's home (at-home treatment)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-Home therapist time
Time Frame: within 18 weeks (after 36 hours of therapy)
The primary endpoint is to demonstrate that at least 24 hours of in-home therapist time occurs within an 18-week period (success criteria of 24 hours or more).
within 18 weeks (after 36 hours of therapy)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Fugl-Meyer (FMA)
Time Frame: within 18 weeks (after 36 hours of therapy)
Change in the FMA assessment measure compared to baseline
within 18 weeks (after 36 hours of therapy)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MicroTransponder Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

January 10, 2023

First Submitted That Met QC Criteria

January 10, 2023

First Posted (Actual)

January 19, 2023

Study Record Updates

Last Update Posted (Estimated)

October 9, 2025

Last Update Submitted That Met QC Criteria

October 7, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MT-St-11

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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