Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population

Description

The purpose of this pilot interventional study is to collect preliminary data on the application of a transcutaneous auricular vagal nerve stimulation (taVNS) device in patients with chronic kidney disease (CKD). This data will enhance understanding of the short-term safety, tolerability and effects of this novel therapeutic approach in the setting of CKD. The primary aims are to investigate the feasibility of the protocol and generate preliminary signals of efficacy and tolerability for two different doses of vagal nerve stimulation. The pilot estimates will be used to design a larger scale study that may lead to potentially targeted interventions to reduce cardiovascular (CV) mortality in the CKD population.

Conditions

Chronic Kidney Disease

Study Overview

Study Details

Study overview

The purpose of this pilot interventional study is to collect preliminary data on the application of a transcutaneous auricular vagal nerve stimulation (taVNS) device in patients with chronic kidney disease (CKD). This data will enhance understanding of the short-term safety, tolerability and effects of this novel therapeutic approach in the setting of CKD. The primary aims are to investigate the feasibility of the protocol and generate preliminary signals of efficacy and tolerability for two different doses of vagal nerve stimulation. The pilot estimates will be used to design a larger scale study that may lead to potentially targeted interventions to reduce cardiovascular (CV) mortality in the CKD population.

A Single Center Pilot Study on the Use of a Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population

Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population

Condition
Chronic Kidney Disease
Intervention / Treatment

-

Contacts and Locations

New York

NYU Langone Health, New York, New York, United States, 11215

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Pacemaker dependent
  • * Prisoners
  • * Pregnant women. A pregnancy test will be offered if a subject is concerned about being pregnant.
  • * Not capable of informed consent
  • * Know autonomic function disorder (e.g. Parkinson's disease with autonomic dysfunction)
  • * ICD or PPM precluding assessment of heart rate variability (e.g. chronic atrial fibrillation)
  • * Recent myocardial infarction (4 weeks or less)
  • * Maintenance dialysis
  • * Epilepsy
  • * Patients on labetalol (labetalol will interfere with catecholamine measurements)
  • * Patients with diabetes
  • * At least 50% of cohort must not be on beta blockers. This will help to distinguish the confounding effects of beta blockers.

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

NYU Langone Health,

David Charytan, MD, PRINCIPAL_INVESTIGATOR, NYU Langone Health

Study Record Dates

2025-08-07