Pilot Study to Determine the Optimal Protocol for Preoperative Transcutaneous Vagal Neurostimulation

Condition(s) studied

Investigational drug(s) / intervention(s)

tVNS session on the left earlobe: \- 15-45 days before the surgery, 1h-2h daily tVNS session is delivered on the conchae aurea of the left ear, in resting condition. Parameters of tVNS: frequency 20Hz, impulsion 200ms, amplitude 1mA below the unpleasant sensation level

tVNS "SHAM" session the conchae aurea of the left ear: \- 15-45 days before the surgery, 1h-2h daily tVNS session is delivered on the left earlobe, in resting condition. Parameters of tVNS: frequency 20Hz, impulsion 200ms, amplitude 1mA below the unpleasant sensation level.

Study summary

Post-operative atrial fibrillation (POAF) is a frequent complication of surgical aortic valve replacement, affecting 38 to 63% of patients, and increasing risks of stroke, heart failure, and long-term mortality. By intervening upstream of surgical stress, transcutaneous vagal nerve stimulation (tVNS) could act as an autonomic and anti-inflammatory preconditioning, stabilizing sympathovagal balance, reducing POAF susceptibility and post-operative outcomes. This pilot study evaluates the feasibility, tolerability, and biological activity of a preoperative tVNS protocol versus sham (1-2 hours/day), with ΔRMSSD, a non-invasive marker of parasympathetic modulation as the primary endpoint, inflammatory biomarkers, postoperative recovery, and cardiovascular events up to 3 months as secondary outcomes. This step is essential to identify a preoperative strategy that is practicable, well-tolerated, and capable of inducing measurable parasympathetic modulation prior to surgery and the prevention of POAF.

Eligibility

Primary outcome measure(s)

• Change From Baseline in RMSSD of Heart Rate Variability After the Last tVNS Session — 15 days
  RMSSD (ms), a measure of parasympathetic cardiac activity, will be measured from HRV recordings (Holter 24h). Recordings will be made before the first session and after the last session of transcutaneous auricular vagus nerve stimulation (tVNS), delivered for 1 to 2 hours per day during the preoperative period. A higher RMSSD indicates greater parasympathetic activity. The outcome is the change in RMSSD from baseline to after the last session.

Trial sites (3)

More Centre Hospitalier Universitaire de Saint Etienne trials in France

Other trials for the same condition