Vagal Nerve Stimulation in Enhanced Stroke Recovery: The VALOR Registry

NCT05694663 | Recruiting DMC FDA Device

• 1 other identifier: STUDY-22-00939
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Fugl Meyer Assessment - Upper Extremity (FMA-UE)

  The Fugl-Meyer Assessment - Upper Extremity (FMA-UE) is a stroke-specific, performance-based impairment index for the upper extremities. It is designed to assess motor functioning in patients with post-stroke hemiplegia of the upper limbs. Scoring is based on direct observation of performance. Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0=cannot perform; 1=performs partially; and 2=performs fully. The total scores range from 0-66, where higher scores indicate better performance.

  Baseline up to day 390

Secondary Outcomes (9)

• Fugl-Meyer Assessment - Lower Extremities (FMA-LE)

  Baseline up to day 390

• Wolf Motor Function Test (WMFT)

  Baseline up to day 390

• Action Research Arm Test (ARAT)

  Baseline up to day 390

• Modified Ranking Score (mRS)

  Baseline up to day 390

• National Institutes of Health Stroke Scale (NIHSS)

  Baseline up to day 390

Study Arms (1)

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.

Device: Vivistim

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.

Also known as: Standard of Care

Patients Undergoing Vagal Nerve Stimulation for Stroke Recovery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study will enroll adult patients with a history of ischemic stroke and upper extremity weakness who plan to undergo vagal nerve stimulation (VNS) implantation.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10128, United States

RECRUITING

Related Publications (12)

• Johnson RL, Wilson CG. A review of vagus nerve stimulation as a therapeutic intervention. J Inflamm Res. 2018 May 16;11:203-213. doi: 10.2147/JIR.S163248. eCollection 2018.

  PMID: 29844694 BACKGROUND

• Lanska DJ. J.L. Corning and vagal nerve stimulation for seizures in the 1880s. Neurology. 2002 Feb 12;58(3):452-9. doi: 10.1212/wnl.58.3.452.

  PMID: 11839848 BACKGROUND

• Bonaz B, Picq C, Sinniger V, Mayol JF, Clarencon D. Vagus nerve stimulation: from epilepsy to the cholinergic anti-inflammatory pathway. Neurogastroenterol Motil. 2013 Mar;25(3):208-21. doi: 10.1111/nmo.12076. Epub 2013 Jan 29.

  PMID: 23360102 BACKGROUND

• Pies R. Regarding managing bipolar depression. Psychiatry (Edgmont). 2006 Apr;3(4):10-1. No abstract available.

  PMID: 21103167 BACKGROUND

• Murphy TH, Corbett D. Plasticity during stroke recovery: from synapse to behaviour. Nat Rev Neurosci. 2009 Dec;10(12):861-72. doi: 10.1038/nrn2735. Epub 2009 Nov 4.

  PMID: 19888284 BACKGROUND

• Engineer ND, Kimberley TJ, Prudente CN, Dawson J, Tarver WB, Hays SA. Targeted Vagus Nerve Stimulation for Rehabilitation After Stroke. Front Neurosci. 2019 Mar 29;13:280. doi: 10.3389/fnins.2019.00280. eCollection 2019.

  PMID: 30983963 BACKGROUND

• Khodaparast N, Hays SA, Sloan AM, Hulsey DR, Ruiz A, Pantoja M, Rennaker RL 2nd, Kilgard MP. Vagus nerve stimulation during rehabilitative training improves forelimb strength following ischemic stroke. Neurobiol Dis. 2013 Dec;60:80-8. doi: 10.1016/j.nbd.2013.08.002. Epub 2013 Aug 15.

  PMID: 23954448 BACKGROUND

• Hays SA, Khodaparast N, Hulsey DR, Ruiz A, Sloan AM, Rennaker RL 2nd, Kilgard MP. Vagus nerve stimulation during rehabilitative training improves functional recovery after intracerebral hemorrhage. Stroke. 2014 Oct;45(10):3097-100. doi: 10.1161/STROKEAHA.114.006654. Epub 2014 Aug 21.

  PMID: 25147331 BACKGROUND

• Dawson J, Liu CY, Francisco GE, Cramer SC, Wolf SL, Dixit A, Alexander J, Ali R, Brown BL, Feng W, DeMark L, Hochberg LR, Kautz SA, Majid A, O'Dell MW, Pierce D, Prudente CN, Redgrave J, Turner DL, Engineer ND, Kimberley TJ. Vagus nerve stimulation paired with rehabilitation for upper limb motor function after ischaemic stroke (VNS-REHAB): a randomised, blinded, pivotal, device trial. Lancet. 2021 Apr 24;397(10284):1545-1553. doi: 10.1016/S0140-6736(21)00475-X.

  PMID: 33894832 BACKGROUND

• U.S. Food and Drug Administration. (2021). Summary of Safety and Effectiveness Data (SSED) for the Vivistim System. https://www.accessdata.fda.gov/cdrh_docs/pdf/p970003s207b.pdf

  BACKGROUND

• Dawson J, Pierce D, Dixit A, Kimberley TJ, Robertson M, Tarver B, Hilmi O, McLean J, Forbes K, Kilgard MP, Rennaker RL, Cramer SC, Walters M, Engineer N. Safety, Feasibility, and Efficacy of Vagus Nerve Stimulation Paired With Upper-Limb Rehabilitation After Ischemic Stroke. Stroke. 2016 Jan;47(1):143-50. doi: 10.1161/STROKEAHA.115.010477. Epub 2015 Dec 8.

  PMID: 26645257 BACKGROUND

• Purser MF, Mladsi DM, Beckman A, Barion F, Forsey J. Expected Budget Impact and Health Outcomes of Expanded Use of Vagus Nerve Stimulation Therapy for Drug-Resistant Epilepsy. Adv Ther. 2018 Oct;35(10):1686-1696. doi: 10.1007/s12325-018-0775-0. Epub 2018 Aug 24.

  PMID: 30143957 BACKGROUND

Study Officials

• Christopher P Kellner, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• David Putrino, PT, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Fedor Panov, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Jenna Tosto, PT, DPT, NCS

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sydney Edwards

CONTACT

Sydney.Edwards@mountsinai.org

Mikhail Nasrallah

CONTACT

mikhail.nasrallah@mountsinai.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Neurosurgery

Study Record Dates

• First Submitted: January 12, 2023
• First Posted: January 23, 2023
• Study Start: October 9, 2024
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)