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Vagus Nerve Stimulation for Autonomic Modulation After Coronary Artery Bypass Graft Surgery
Sponsor: Hospital de Clinicas de Porto Alegre
Summary
The objective of this randomized clinical trial is to investigate whether transcutaneous auricular vagus nerve stimulation (taVNS) can improve the recovery of patients undergoing coronary artery bypass grafting (CABG) through autonomic modulation, while also evaluating the safety of the intervention. The main questions this study aims to answer are: * Does taVNS improve autonomic modulation, as assessed by heart rate variability, in patients undergoing CABG? * Does taVNS reduce the inflammatory response and pain intensity while improving quality of life and functional capacity during the postoperative period? * Is taVNS a safe and well-tolerated intervention during recovery after CABG? The researchers will compare taVNS with a control group (sham stimulation/placebo) to determine whether the intervention leads to better clinical and functional outcomes in patients undergoing coronary artery bypass grafting. Participants will: * Receive sessions of transcutaneous auricular vagus nerve stimulation (taVNS) or sham stimulation (placebo), according to the study randomization. * Undergo assessments of autonomic modulation using heart rate variability before and after the intervention. * Be evaluated for inflammatory markers, pain intensity, quality of life, and functional capacity at different time points during the postoperative period.
Official title: Vagus Nerve Stimulation for Autonomic Modulation in Patients Undergoing Coronary Artery Bypass Grafting: A Randomized Clinical Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
58
Start Date
2025-08-31
Completion Date
2026-06-30
Last Updated
2026-10-01
Healthy Volunteers
No
Interventions
Transcutaneous auricular vagus nerve stimulation
Transcutaneous auricular vagus nerve stimulation (taVNS) will be performed daily for 30 minutes until hospital discharge. One electrode will be placed on the auricular concha to stimulate the auricular branch of the vagus nerve, and the other electrode will be positioned on the left earlobe to stimulate the great auricular nerve. The stimulation will be delivered using the EL-30 device (NKL Produtos Eletrônicos, Brusque, SC, Brazil), with a pulse width of 250 μs, intensity below the pain threshold, and alternating frequencies of 2 Hz for 5 seconds and 15 Hz for 5 seconds. The stimulation sites were selected based on auricular innervation, technical feasibility, and treatment standardization.The control group will use the same device; however, no active electrical current will be delivered (placebo stimulation).
Locations (2)
Hospital de Clinicas de Ijuí
Ijuí, Rio Grande do Sul, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil