Bashar W Badran1, Oliver J Mithoefer2, Caroline E Summer2, Nicholas T LaBate3, Chloe E Glusman2, Alan W Badran4, William H DeVries2, Philipp M Summers2, Christopher W Austelle2, Lisa M McTeague2, Jeffrey J Borckardt5, Mark S George6. 1. Department of Neuroscience, Medical University of South Carolina, Charleston SC 29425, United States; Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston SC 29425, United States; Department of Psychology, University of New Mexico, Albuquerque, NM 87106, United States; U.S. Army Research Lab, Aberdeen Proving Ground, MD 21005, United States. Electronic address: basharwbadran@gmail.com. 2. Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston SC 29425, United States. 3. College of Charleston, Charleston SC 29403, United States. 4. Department of Aviation and Technology, San Jose State University, San Jose CA 95192, United States. 5. Department of Neuroscience, Medical University of South Carolina, Charleston SC 29425, United States; Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston SC 29425, United States. 6. Department of Neuroscience, Medical University of South Carolina, Charleston SC 29425, United States; Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston SC 29425, United States; Ralph H. Johnson VA Medical Center, Charleston SC 29401, United States.
Abstract
BACKGROUND: Optimal parameters of transcutaneous auricular vagus nerve stimulation (taVNS) are still undetermined. Given the vagus nerve's role in regulating heart rate (HR), it is important to determine safety and HR effects of various taVNS parameters. OBJECTIVE: We conducted two sequential trials to systematically test the effects of various taVNS parameters on HR. METHODS:15 healthy individuals participated in the initial two-visit, crossover exploratory trial, receiving eithertragus (active) or earlobe (control) stimulation each visit. Nine stimulation blocks of varying parameters (pulse width: 100 μs, 200 μs, 500 μs; frequency: 1 Hz, 10 Hz, 25 Hz) were administered each visit. HR was recorded and analyzed for stimulation-induced changes. Using similar methods and the two best parameters from trial 1 (500μs 10 Hz and 500μs 25 Hz), 20 healthy individuals then participated in a follow-up confirmatory study. RESULTS: Trial 1- There was no overall effect of the nine conditions on HR during stimulation. However multivariate analysis revealed two parameters that significantly decreased HR during active stimulation compared to control (500μs 10 Hz and 500μs 25 Hz; p < 0.01). Additionally, active taVNS significantly attenuated overall sympathetic HR rebound (post-stimulation) compared to control (p < 0.001). Trial 2-For these two conditions, active taVNS significantly decreased HR compared to control (p = 0.02), with the strongest effects at 500μs 10 Hz (p = 0.032). CONCLUSION: These studies suggest that 60s blocks of tragus stimulation are safe, and some specific parameters modulate HR. Of the nine parameters studied, 500μs 10 Hz induced the greatest HR effects.
RCT Entities:
BACKGROUND: Optimal parameters of transcutaneous auricular vagus nerve stimulation (taVNS) are still undetermined. Given the vagus nerve's role in regulating heart rate (HR), it is important to determine safety and HR effects of various taVNS parameters. OBJECTIVE: We conducted two sequential trials to systematically test the effects of various taVNS parameters on HR. METHODS: 15 healthy individuals participated in the initial two-visit, crossover exploratory trial, receiving either tragus (active) or earlobe (control) stimulation each visit. Nine stimulation blocks of varying parameters (pulse width: 100 μs, 200 μs, 500 μs; frequency: 1 Hz, 10 Hz, 25 Hz) were administered each visit. HR was recorded and analyzed for stimulation-induced changes. Using similar methods and the two best parameters from trial 1 (500μs 10 Hz and 500μs 25 Hz), 20 healthy individuals then participated in a follow-up confirmatory study. RESULTS: Trial 1- There was no overall effect of the nine conditions on HR during stimulation. However multivariate analysis revealed two parameters that significantly decreased HR during active stimulation compared to control (500μs 10 Hz and 500μs 25 Hz; p < 0.01). Additionally, active taVNS significantly attenuated overall sympathetic HR rebound (post-stimulation) compared to control (p < 0.001). Trial 2-For these two conditions, active taVNS significantly decreased HR compared to control (p = 0.02), with the strongest effects at 500μs 10 Hz (p = 0.032). CONCLUSION: These studies suggest that 60s blocks of tragus stimulation are safe, and some specific parameters modulate HR. Of the nine parameters studied, 500μs 10 Hz induced the greatest HR effects.
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