RECRUITING

Vagal Nerve Stimulation in Enhanced Stroke Recovery: The VALOR Registry

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Vagal Nerve Stimulation in Enhanced Stroke Recovery: The VALOR Registry

Quick Facts

Study Start:2022-11-01
Study Completion:2028-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05694663

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Provision of signed and dated informed consent form
  2. * Stated willingness to comply with all procedures in the VNS-Enhanced Stroke Recovery Program
  3. * Aged 18 or older
  4. * History of ischemic stroke
  5. * Upper extremity weakness
  6. * Planned to undergo VNS implantation
  1. * 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.).
  2. * Medical or mental instability (diagnosis of personality disorder, psychosis, or substance abuse) that would prevent the subject from meeting protocol timeline.

Contacts and Locations

Study Contact

Christopher P Kellner, MD
CONTACT
212-241-2606
christopher.kellner@mountsinai.org
Margaret H Downes, BA
CONTACT
margaret.downes@icahn.mssm.edu

Principal Investigator

Christopher P Kellner, MD
PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
David Putrino, PT, PhD
PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Fedor Panov, MD
PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Jenna Tosto, PT, DPT, NCS
PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai

Study Locations (Sites)

Icahn School of Medicine at Mount Sinai
New York, New York, 10128
United States

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

  • Christopher P Kellner, MD, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai
  • David Putrino, PT, PhD, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai
  • Fedor Panov, MD, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai
  • Jenna Tosto, PT, DPT, NCS, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-01
Study Completion Date2028-12

Study Record Updates

Study Start Date2022-11-01
Study Completion Date2028-12

Terms related to this study

Additional Relevant MeSH Terms

  • Chronic Ischemic Stroke