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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05694663
Study type Observational [Patient Registry]
Source Icahn School of Medicine at Mount Sinai
Contact Christopher P Kellner, MD
Phone 212-241-2606
Email christopher.kellner@mountsinai.org
Status Recruiting
Phase
Start date November 1, 2022
Completion date October 2023

See also
  Status Clinical Trial Phase
Completed NCT02448641 - Study of Modified Stem Cells (SB623) in Patients With Chronic Motor Deficit From Ischemic Stroke Phase 2
Completed NCT01287936 - A Study of Modified Stem Cells in Stable Ischemic Stroke Phase 1/Phase 2