Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population

Phase

N/A

Condition

Focal Segmental Glomerulosclerosis

Nephropathy

Kidney Disease

Treatment

Transcutaneous electrical nerve stimulation unit (TENS)

Clinical Study ID

NCT05981183

23-00778

Ages 18-80
All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

Pacemaker dependent
Prisoners
Pregnant women. A pregnancy test will be offered if a subject is concerned aboutbeing pregnant.
Not capable of informed consent
Know autonomic function disorder (e.g. Parkinson's disease with autonomicdysfunction)
ICD or PPM precluding assessment of heart rate variability (e.g. chronic atrialfibrillation)
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 distinguishthe confounding effects of beta blockers.

Study Design