RecruitingNot Applicable

Vagal Nerve Stimulation in Enhanced Stroke Recovery: The VALOR Registry

United States40 participantsStarted 2024-10-09

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

Fugl Meyer Assessment - Upper Extremity (FMA-UE)

Timeframe: Baseline up to day 390

Trial details

NCT IDNCT05694663

SponsorIcahn School of Medicine at Mount Sinai

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-02

Contact for this trial

Emily Svendsen

(212) 241-3238 Emily.Svendsen@mountsinai.org