Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population

NYU Langone Health

Status: Enrolling

Conditions: Chronic Kidney Disease

Treatments: Device: Transcutaneous electrical nerve stimulation unit (TENS)

Study type: Interventional

Funder types: Other

Identifiers

NCT05981183

23-00778

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Individual 18-80 years of age with CKD stage 3-5 (eGFR <60 mL/min/1.73m2) on most recent outpatient labs.

Exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Intervention A

Experimental group

Description:

Participants will receive 15 minutes of taVNS after an initial 15 minute rest-period and a 15 minute baseline measurement period. For participants assigned to Intervention A, the pulse width = 250 μs, and frequency = 50 Hz.

Treatment:

Device: Transcutaneous electrical nerve stimulation unit (TENS)

Intervention B

Experimental group

Description:

Participants will receive 15 minutes of taVNS after an initial 15 minute rest-period and a 15 minute baseline measurement period. For participants assigned to Intervention B, the pulse width = 300 μs, frequency = 25 Hz.

Treatment:

Device: Transcutaneous electrical nerve stimulation unit (TENS)