At-home therapy using the Vivistim System for stroke recovery
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 study is testing whether at-home therapy using the Vivistim System can help people recover better from arm weakness after a stroke compared to regular in-clinic therapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | MicroTransponder Inc. Industry-sponsored |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT05691023 on ClinicalTrials.gov |
What this trial studies
This observational study involves up to 150 participants who have been implanted with the Vivistim System, focusing on at-home rehabilitation therapy for upper extremity motor deficits following ischemic stroke. Participants will receive therapy from mobile therapists in their homes, combined with self-activated vagus nerve stimulation (VNS) for enhanced recovery. The study consists of two stages: an acute treatment phase lasting up to 18 weeks and a long-term follow-up phase of up to two years, assessing the effectiveness of this home-based approach compared to traditional in-clinic therapy.
Who should consider this trial
Good fit: Ideal candidates are adults who have been implanted or are scheduled to be implanted with the Vivistim System and can receive therapy at home.
Not a fit: Patients under 18 years old or pregnant women will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve motor function and recovery outcomes for stroke patients in the comfort of their homes.
How similar studies have performed: While the use of VNS in rehabilitation is a novel approach, similar studies have shown promise in enhancing recovery outcomes for stroke patients.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Chicago, Illinois
- Moxie OT — Chicago, Illinois, United States (Recruiting)
Study contacts
- Study coordinator: VP Clinical
- Email: brent@microtransponder.com
- Phone: 8556289375
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.