Biomarker-Guided Optimization of Transcutaneous Vagal Stimulation for Atrial (BiG tVNS-AF)
University of Oklahoma
Summary
This proposal aims to determine the effects of tVNS on autonomic tone, atrial substrate and neuromodulators in patients with paroxysmal atrial fibrillation (AF), investigate the chronic effects of optimal tVNS on AF burden in patients with paroxysmal AF over a 6-month period, compared with sham stimulation, and identify physiological and biochemical markers of response to chronic tVNS.
Description
This proposal aims to 1. To determine the effects of tVNS on autonomic tone, atrial substrate and neuromodulators in patients with paroxysmal atrial fibrillation (AF), 2. Investigate the chronic effects of optimal tVNS on AF burden in patients with paroxysmal AF over a 6-month period, compared with sham stimulation, and 3. To identify physiological and biochemical markers of response to chronic tVNS. For Aim 1, patients with paroxysmal AF will be randomized to a series of stimulation frequencies (5Hz, 10Hz, 20Hz) and intensities (50% below, and 1mA lower than, the discomfort threshold, respect…
Eligibility
- Age range
- 21–90 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1\. Paroxysmal atrial fibrillation Exclusion Criteria: 1. Sick sinus syndrome 2. 2nd and 3rd degree AV block (without pacemaker), bifascicular block or prolonged (PR\>300ms) 1st degree AV block 3. History of vagotomy 4. Recurrent vasovagal syncope 5. Left ventricular ejection fraction \< 40% 6. Significant valvular disorder (i.e., prosthetic valve or hemodynamic significant valvular diseases) 7. Recent stroke (\< 3 months) 8. Myocardial infarction or hospitalization for heart failure (\< 3 months) 9. Severe heart failure (NYHA Class IV) 10. End stage kidney disease on di…
Interventions
- DeviceTranscutaneous Electrical Nerve Stimulation Device
Low-level, electrical stimulation of the outer ear (LLTS), using a transcutaneous electrical nerve stimulation (TENS) device.
Location
- University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma