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

NCT ID: NCT04682704

Last Updated: 2024-02-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-30
• Study Completion Date: 2025-02-28

Brief 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.

Conditions

Atrial Fibrillation; Heart Failure, Diastolic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Parasym

Intervention Type: DEVICE

Tragus stimulation

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.

Group Type: ACTIVE_COMPARATOR

Parasym

Intervention Type: DEVICE

Tragus stimulation

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.

Group Type: ACTIVE_COMPARATOR

Parasym

Intervention Type: DEVICE

Tragus stimulation

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.

Group Type: ACTIVE_COMPARATOR

Parasym

Intervention Type: DEVICE

Tragus stimulation

Interventions

Parasym

Tragus stimulation

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Male and female patients older than 21 year old

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

3. Patients with Paroxysmal Atrial Fibrillation

4. Patients with Heart Failure with Preserved Ejection Fraction (HFpEF)

Exclusion Criteria

1. Recent (<6 months) stroke

2. Recent (<6 months) myocardial infarction

3. Heart failure (NYHA class III or IV)

4. Left ventricular ejection fraction <50%

5. Recurrent vaso-vagal syncopal episodes

6. Unilateral or bilateral vagotomy

7. Pregnancy or breast feeding

8. Uncontrolled diabetes or hypertension

9. Inability or unwillingness to understand and/or sign informed consent

10. Any serious disease that affects autonomic nervous system function

11. Any medications that affect autonomic nervous system function

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stavros Stavrakis, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Locations

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Karrie Meeks

Role: CONTACT

karrie-meeks@ouhsc.edu

4052714742

Facility Contacts

Brittany Karfonta, RN

Role: primary

brittany-karfonta@ouhsc.edu

405-271-2229

Other Identifiers

12708

Identifier Type: -

Identifier Source: org_study_id