Vagal Nerve Stimulation in Enhanced Stroke Recovery: The VALOR Registry
NCT ID: NCT05694663
Last Updated: 2024-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2022-11-01
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Medical or mental instability (diagnosis of personality disorder, psychosis, or substance abuse) that would prevent the subject from meeting protocol timeline.
18 Years
ALL
No
Sponsors
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Icahn School of Medicine at Mount Sinai
OTHER
Responsible Party
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Christopher P Kellner
Assistant Professor Neurosurgery
Principal Investigators
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Christopher P Kellner, MD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
David Putrino, PT, PhD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Fedor Panov, MD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Jenna Tosto, PT, DPT, NCS
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Locations
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Icahn School of Medicine at Mount Sinai
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
Pies R. Regarding managing bipolar depression. Psychiatry (Edgmont). 2006 Apr;3(4):10-1. No abstract available.
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.
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.
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.
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.
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.
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
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.
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.
Other Identifiers
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STUDY-22-00939
Identifier Type: -
Identifier Source: org_study_id
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