Vagal Nerve Stimulation in Enhanced Stroke Recovery: The VALOR Registry

Recruiting now

Conditions studied: Chronic Ischemic Stroke

In brief

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.

Key facts

Study ID

NCT05694663

Run by

Icahn School of Medicine at Mount Sinai

People needed

40

Starts

2024-10-09

Expected to finish

2028-02-01

Last updated by the study team

2026-05-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Icahn School of Medicine at Mount Sinai — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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