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Ischemic StrokeAT-HOMENCT05691023

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

An observational study of Ischemic Stroke and Upper Extremity Problem, run by MicroTransponder Inc. at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Ischemic Stroke, Upper Extremity Problem
What is being tested?
Vivistim System
Type of treatment
Medical device
How many people
50 participants
Where
1 siteUnited States
Study dates
1 Jun 2023to 31 Dec 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • Patient aged 18 or younger.
  • Pregnant women

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Moxie OT

    Chicago, Illinois, 60618

Other trials in United States

About this 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)

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.

Read the 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.
Being tested
Vivistim System
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vivistim SystemDevice

    Paired VNS during rehabilitation, facilitated by a rehab therapist in the subject's home (at-home treatment)

Study groups in NCT05691023
Study groupRoleWhat they receive
VivistimAll subjects will be commercially implanted with the Vivistim System® after an ischemic stroke prior to Study treatment.
Receives: Device: Vivistim System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. In-Home therapist time

    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).

    Measured: within 18 weeks (after 36 hours of therapy)

Secondary outcomes (1)

  1. Change in Fugl-Meyer (FMA)

    Change in the FMA assessment measure compared to baseline

    Measured: within 18 weeks (after 36 hours of therapy)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2023
  2. Study start1 Jun 2023
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05691023
Sponsor's protocol ID
MT-St-11
Acronym
AT-HOME
Status last verified
Oct 2025
First submitted
10 Jan 2023
Last updated
9 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Dawson J, Liu CY, Francisco GE, Cramer SC, Wolf SL, Dixit A, Alexander J, Ali R, Brown BL, Feng W, DeMark L, Hochberg LR, Kautz SA, Majid A, O'Dell MW, Pierce D, Prudente CN, Redgrave J, Turner DL, Engineer ND, Kimberley TJ. Vagus nerve stimulation paired with rehabilitation for upper limb motor function after ischaemic stroke (VNS-REHAB): a randomised, blinded, pivotal, device trial. Lancet. 2021 Apr 24;397(10284):1545-1553. doi: 10.1016/S0140-6736(21)00475-X.

    PubMed 33894832

  • Engineer ND, Kimberley TJ, Prudente CN, Dawson J, Tarver WB, Hays SA. Targeted Vagus Nerve Stimulation for Rehabilitation After Stroke. Front Neurosci. 2019 Mar 29;13:280. doi: 10.3389/fnins.2019.00280. eCollection 2019.

    PubMed 30983963

  • Kimberley TJ, Pierce D, Prudente CN, Francisco GE, Yozbatiran N, Smith P, Tarver B, Engineer ND, Alexander Dickie D, Kline DK, Wigginton JG, Cramer SC, Dawson J. Vagus Nerve Stimulation Paired With Upper Limb Rehabilitation After Chronic Stroke. Stroke. 2018 Nov;49(11):2789-2792. doi: 10.1161/STROKEAHA.118.022279.

    PubMed 30355189

  • Dawson J, Engineer ND, Prudente CN, Pierce D, Francisco G, Yozbatiran N, Tarver WB, Casavant R, Kline DK, Cramer SC, Van de Winckel A, Kimberley TJ. Vagus Nerve Stimulation Paired With Upper-Limb Rehabilitation After Stroke: One-Year Follow-up. Neurorehabil Neural Repair. 2020 Jul;34(7):609-615. doi: 10.1177/1545968320924361. Epub 2020 Jun 1.

    PubMed 32476617

  • Dawson J, Engineer ND, Cramer SC, Wolf SL, Ali R, O'Dell MW, Pierce D, Prudente CN, Redgrave J, Feng W, Liu CY, Francisco GE, Brown BL, Dixit A, Alexander J, DeMark L, Krishna V, Kautz SA, Majid A, Tarver B, Turner DL, Kimberley TJ. Vagus Nerve Stimulation Paired With Rehabilitation for Upper Limb Motor Impairment and Function After Chronic Ischemic Stroke: Subgroup Analysis of the Randomized, Blinded, Pivotal, VNS-REHAB Device Trial. Neurorehabil Neural Repair. 2023 Jun;37(6):367-373. doi: 10.1177/15459683221129274. Epub 2022 Oct 13.

    PubMed 36226541

  • Patel R, Spinelli-Guglielmo L, Antares KA, Diedrich A, Zera SM. 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 May 13;15:27536351261447473. doi: 10.1177/27536351261447473. eCollection 2026 Jan-Dec.

    PubMed 42146328

Questions about this trial

What is this clinical trial studying?

An observational study of Ischemic Stroke and Upper Extremity Problem, run by MicroTransponder Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

In-Home therapist time (time frame: within 18 weeks (after 36 hours of therapy)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05691023, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2025.

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