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NCT05691023 · ClinicalTrials.gov registry record
VNS-REHAB At-Home - Post-Market Study for Using the Vivistim System® at Home
A clinical trial of Ischemic Stroke and Upper Extremity Problem, sponsored by MicroTransponder.
- Active
- Registry status
- 50
- Enrollment target
- 1
- Study location
NCT05691023: Active study of Ischemic Stroke and Upper Extremity Problem, sponsored by MicroTransponder.
NCT05691023 is a study of Ischemic Stroke and Upper Extremity Problem that is active but no longer recruiting, run by MicroTransponder. The registered enrollment target is 50 participants, below the 1,463-participant average among 66 other Ischemic Stroke trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05691023, a study of Ischemic Stroke and Upper Extremity Problem, is active but no longer recruiting, sponsored by MicroTransponder.
- ACTIVE NOT RECRUITING
- Registry status
- 50 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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).
Conditions Studied
Interventions
- DEVICE Vivistim System
Study Locations (1)
Illinois
- Moxie OT - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2023-06-01 |
| Est. Completion | 2028-12-31 |
What the registry record for NCT05691023 still lists
NCT05691023 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 1,463-participant average among 66 other Ischemic Stroke trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Ischemic Stroke appearing as the primary indexed condition, and to 1 intervention - of which Vivistim System is the first listed.
NCT05691023 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT05691023 about?
NCT05691023 is a clinical study titled "VNS-REHAB At-Home - Post-Market Study for Using the Vivistim System® 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 Vivis...
What is the current status of trial NCT05691023?
This trial is currently active not recruiting. The enrollment target is 50 participants. The study started on 2023-06-01. Estimated completion is 2028-12-31.
What conditions does trial NCT05691023 study?
This clinical trial studies the following conditions: Ischemic Stroke, Upper Extremity Problem.
What interventions are being tested in trial NCT05691023?
The interventions under investigation include: Vivistim System (DEVICE).
Who is sponsoring clinical trial NCT05691023?
This trial is sponsored by MicroTransponder, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05691023 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05691023's enrollment target sits among peer trials
50 44th of 66 higher than 22 of 66 other Ischemic Stroke trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ischemic Stroke trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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