Vagal Nerve Stimulation in Enhanced Stroke Recovery: The VALOR Registry

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
New York
Icahn School of Medicine at Mount Sinai
RECRUITING
New York
Contact Information
Primary
Christopher P Kellner, MD
christopher.kellner@mountsinai.org
212-241-2606
Backup
Margaret H Downes, BA
margaret.downes@icahn.mssm.edu
Time Frame
Start Date: 2022-11-01
Estimated Completion Date: 2028-12
Participants
Target number of participants: 100
Treatments
Patients Undergoing Vagal Nerve Stimulation for Stroke Recovery
Individuals undergoing vagal nerve stimulation (VNS) paired rehabilitation will be included in this cohort.~This is a registry study with no active intervention outside standard of care. Patients with chronic ischemic stroke will be implanted with the Vivistim vagal nerve stimulation device per standard of care.
Related Therapeutic Areas
Sponsors
Leads: Icahn School of Medicine at Mount Sinai

This content was sourced from clinicaltrials.gov