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NCT05694663
Vagal Nerve Stimulation in Enhanced Stroke Recovery: The VALOR Registry
Conditions: Chronic Ischemic Stroke
Sex: All
Ages: 18 Years – N/A
Enrollment: 100
Sponsor: Icahn School of Medicine at Mount Sinai
Location: United States
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.
Eligibility Criteria
Inclusion Criteria:Provision of signed and dated informed consent formStated willingness to comply with all procedures in the VNS-Enhanced Stroke Recovery ProgramAged 18 or olderHistory of ischemic strokeUpper extremity weaknessPlanned to undergo VNS implantationExclusion 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.
Source: ClinicalTrials.gov (NCT05694663). StuddyBuddy aggregates publicly available trial information.