Recruiting

Vagal Nerve Stimulation

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT05694663

Conditions

Chronic Ischemic Stroke

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Vivistim

Study Details

Brief summary:

Vagal Nerve Stimulation is a novel proven therapy for patients with chronic ischemic stroke. The primary objective of this registry is to assess the safety of vagal nerve stimulation for stroke recovery through monitoring the occurrence of serious adverse events associated with the surgical procedure or subsequent paired rehabilitation protocol. This registry will monitor patients undergoing VNS for stroke recovery in the Mount Sinai Health System and collect clinical and procedural details, objective outcomes, and patient-reported outcomes associated with vagal nerve stimulation for stroke recovery.

Conditions

Chronic Ischemic Stroke

Study ID

NCT05694663

Start date

Oct 9, 2024

Status verified date

Feb, 2026

Completion date

Feb, 2028

Anticipated

Primary completion date

Feb, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients Undergoing Vagal Nerve Stimulation for Stroke Recovery

Individuals undergoing vagal nerve stimulation (VNS) paired rehabilitation will be included in this cohort.

This is a registry study with no active intervention outside standard of care. Patients with chronic ischemic stroke will be implanted with the Vivistim vagal nerve stimulation device per standard of care.

Interventions

Vivistim

After one month of prehabiliatory training, the patient will then undergo surgical placement of the implantable VNS device (Vivistim System) consisting of an implantable neurostimulator and an implantable lead and electrode per standard of care. The device comes with a controller and software system which allows for control of the stimulation settings during the rehabilitation phase. The PMA number for this device is 210007 and the date of FDA notice of approval occurred on August 27, 2021.

Primary outcome measure

  • Fugl Meyer Assessment - Upper Extremity (FMA-UE) [ Time Frame: Baseline up to day 390 ]

Central Contacts and Locations

Central contacts

Emily Svendsen

(212) 241-3238Emily.Svendsen@mountsinai.org

Sydney Edwards

(212) 241-2524Sydney.Edwards@mountsinai.org

Locations

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10128

Principal Investigator:

Christopher P Kellner, MD

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

May 8, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-05-08.