Vagal nerve stimulation for improving recovery after stroke
Official title: Vagal Nerve Stimulation in Enhanced Stroke Recovery: The VALOR Registry
Run by Icahn School of Medicine at Mount Sinai · NCT05694663 · Data updated 2026-11-12
This study is testing if vagal nerve stimulation can help people recovering from a stroke feel better and improve their recovery process.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 1 site (New York, New York) |
| Status | Recruiting |
| Started | October 9, 2024 |
| Main results expected | February 2028 |
| Study ends | February 2028 |
| Registry record updated | May 8, 2026 |
| Trial ID | NCT05694663 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 or older with a history of ischemic stroke and upper extremity weakness who are planning to undergo VNS implantation.
✕Probably not a fit
Patients who are poor surgical candidates or have medical or mental instability may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This registry focuses on the safety and efficacy of vagal nerve stimulation (VNS) as a treatment for patients recovering from chronic ischemic stroke. It involves monitoring patients who are undergoing VNS implantation and subsequent rehabilitation to assess any serious adverse events and gather clinical outcomes. The study aims to collect both objective data and patient-reported experiences to evaluate the overall impact of VNS on stroke recovery. By analyzing these outcomes, the registry seeks to provide insights into the feasibility and effectiveness of this novel therapy.
Why it matters
Potential benefit: If successful, this approach could enhance recovery outcomes for patients suffering from chronic ischemic stroke.
How similar studies have gone: Other studies have shown promising results with vagal nerve stimulation for various conditions, indicating potential for success in this novel application.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Provision of signed and dated informed consent form * Stated willingness to comply with all procedures in the VNS-Enhanced Stroke Recovery Program * Aged 18 or older * History of ischemic stroke * Upper extremity weakness * Planned to undergo VNS implantation Exclusion Criteria: * Unfavorable candidacy for device implant surgery (e.g., history of adverse reactions to anesthetics, poor surgical candidate in surgeon's opinion, prior injury to the vagus nerve etc.). * Medical or mental instability (diagnosis of personality disorder, psychosis, or substance abuse) that would prevent the subject from meeting protocol timeline.
Where it's running
-
Icahn School of Medicine at Mount Sinai
New York, New York, United States Recruiting
Study contacts
- Principal investigator: Christopher P Kellner, MD — Icahn School of Medicine at Mount Sinai
- Study coordinator: Emily Svendsen
- Email: Emily.Svendsen@mountsinai.org
- Phone: (212) 241-3238
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.