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NCT05694663Recruiting

Vagal Nerve Stimulation in Enhanced Stroke Recovery: The VALOR Registry

Icahn School of Medicine at Mount Sinai

Start Date

10/9/2024

Completion Date

2/1/2028

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.

Detailed Description

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DEVICE

Vivistim

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Conditions

Chronic Ischemic Stroke

Locations

Icahn School of Medicine at Mount Sinai

New York, New York 10128

United States