Vagal Nerve Stimulation in Enhanced Stroke Recovery: The VALOR Registry

Обзор

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.

Подробное описание

The Vagal Nerve Stimulation device implantation is a common, standardized neurosurgical procedure that has been performed for over two decades for the treatment of epilepsy and depression and has recently been approved for chronic ischemic stroke. The intended purpose of this registry is to monitor the safety, feasibility, and efficacy of vagal nerve stimulation for stroke recovery. This will be accomplished by monitoring the occurrence of serious adverse events associated with the surgical procedure or subsequent paired rehabilitation protocol. The secondary objectives of this study focus on the feasibility and efficacy of employing vagal nerve stimulation for ischemic stroke recovery, as well as obtaining qualitative data on the experience associated with stroke rehabilitation paired with VNS. Additional research questions regarding vagal nerve stimulation for stroke recovery may be addressed as well.

Вмешательства

• Устройство 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.

Первичные конечные точки

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

Вторичные конечные точки (9)

• Fugl-Meyer Assessment - Lower Extremities (FMA-LE) [Срок оценки: Baseline up to day 390]
• Wolf Motor Function Test (WMFT) [Срок оценки: Baseline up to day 390]
• Action Research Arm Test (ARAT) [Срок оценки: Baseline up to day 390]
• Modified Ranking Score (mRS) [Срок оценки: Baseline up to day 390]
• National Institutes of Health Stroke Scale (NIHSS) [Срок оценки: Baseline up to day 390]
• Stroke Impact Scale (SIS) [Срок оценки: Baseline up to day 390]
• Montreal Cognitive Assessment (MoCA) [Срок оценки: Baseline up to day 390]
• Patient Reported Outcomes Measurement Information System 29 version 2.1 (PROMIS-29 v2.1) Score [Срок оценки: Baseline up to day 390]
• Beck Depression Inventory (BDI) [Срок оценки: Baseline up to day 390]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• Icahn School of Medicine at Mount Sinai — New York

Публикации

• 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
• 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
• 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
• Pies R. Regarding managing bipolar depression. Psychiatry (Edgmont). 2006 Apr;3(4):10-1. No abstract available. PMID 21103167
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT05694663 · STUDY-22-00939

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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