Vagal Nerve Stimulation in Enhanced Stroke Recovery: The VALOR Registry

Part of paid clinical trials in New York, New York.

Sponsor: Icahn School of Medicine at Mount Sinai
Study ID: NCT05694663
Status: Recruiting

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Conditions

Chronic Ischemic Stroke

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Vivistim — DEVICE
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.

Study Details

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.

Key Dates

Start date: Oct 9, 2024
Status verified: Feb 2026
Primary completion: Feb 29, 2028
Completion: Feb 29, 2028

Study Design

Enrollment: 40 participants (estimated)

Arms

Arm: 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.

Primary Outcome Measure

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

Central Contacts

Emily Svendsen
(212) 241-3238
[email protected]
Sydney Edwards
(212) 241-2524
[email protected]

Locations (1)

Facility	City	State	ZIP	Site coordinators
Icahn School of Medicine at Mount Sinai	New York	New York	10128	Christopher P Kellner, MD (PRINCIPAL_INVESTIGATOR) David Putrino, PT, PhD (PRINCIPAL_INVESTIGATOR) Fedor Panov, MD (PRINCIPAL_INVESTIGATOR) Jenna Tosto, PT, DPT, NCS (PRINCIPAL_INVESTIGATOR)

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Icahn School of Medicine at Mount Sinai· New York, NY