The Effect of Different Low-Level Tragus Stimulation Parameters On Autonomic Nervous System Function

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Low level transcutaneous vagus nerve stimulation (LLTS) involves delivery of electrical impulses transcutaneously at the auricular branch of vagus nerve and it has been shown to have anti-inflammatory and anti-arrhythmic effects. In previous studies from our laboratory, we found that LLTS significantly suppressed atrial fibrillation (AF) inducibility and decreased AF duration. The anti-arrhythmic effects of LLTS were similar to those delivered to the cervical VN trunk. LLTS for just one hour significantly shortened the AF duration and decreased inflammatory cytokines. We have also shown that LLTS leads to favorable heart rate variability (HRV) changes and cardiac mechanics in patients with diastolic dysfunction. These results support the use of LLTS as a novel non-pharmacological, non-ablative treatment modality for AF and possibly other inflammatory conditions. However, the optimal stimulation parameters of LLTS remain to be determined. In this study, we aim to examine the effect of 2 different frequencies (5Hz and 20Hz) and 2 different amplitudes (50% below the pain threshold and 1mA below the pain threshold) of LLTS on heart rate variability with deep breathing (HRVdb), mental arithmetic stress test (MAST), frequency domain measures of heart rate variability (HRV) and brain stem evoked potentials (BSEVP) in healthy volunteers and patients with AF or heart failure with preserved ejection fraction (HFpEF). HRV is a marker of vagus nerve activity and can be easily measured by software calculating the distance between consecutive R waves on the ECG. BSEVP are a surrogate for the central projections of the vagus nerve. Patients will be randomized into 4 groups in a 2x2 factorial design. LLTS will be delivered through a transcutaneous electrical nerve stimulation (TENS) device for 15 minutes. HRVdb, HRV and BSEVP will be measured before and after LLTS and compared.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 90
Healthy Volunteers: t
View:

• Male and female patients older than 21 year old

• Healthy volunteers free from diagnosis of AF, heart failure, coronary artery disease or diseases that affect the autonomic nervous system.

• Patients with Paroxysmal Atrial Fibrillation

• Patients with Heart Failure with Preserved Ejection Fraction (HFpEF)

Locations
United States
Oklahoma
University of Oklahoma Health Sciences Center
RECRUITING
Oklahoma City
Contact Information
Primary
Karrie Meeks
karrie-meeks@ouhsc.edu
4052714742
Time Frame
Start Date: 2021-11-30
Estimated Completion Date: 2025-02
Participants
Target number of participants: 90
Treatments
Experimental: Frequency 20Hz; amplitude 1mA below discomfort threshold
Patients will receive tragus stimulation for 15 minutes using the following settings: Frequency 20Hz; amplitude 1mA below discomfort threshold. Continuous ECG will be recorded to assess heart rate variability.
Active_comparator: Frequency 5Hz; amplitude 1mA below discomfort threshold
Patients will receive tragus stimulation for 15 minutes using the following settings: Frequency 5Hz; amplitude 1mA below discomfort threshold. Continuous ECG will be recorded to assess heart rate variability.
Active_comparator: Frequency 20Hz; amplitude 50% below discomfort threshold
Patients will receive tragus stimulation for 15 minutes using the following settings: Frequency 20Hz; amplitude 50% below discomfort threshold. Continuous ECG will be recorded to assess heart rate variability.
Active_comparator: Frequency 5Hz; amplitude 50% below discomfort threshold
Patients will receive tragus stimulation for 15 minutes using the following settings: Frequency 5Hz; amplitude 50% below discomfort threshold. Continuous ECG will be recorded to assess heart rate variability.
Sponsors
Leads: University of Oklahoma

This content was sourced from clinicaltrials.gov