NCT06998784

Effect of Transcutaneous Auricular Vagal Nerve Stimulation on Acute Pancreatitis

Effect of Transcutaneous Auricular Vagal Nerve Stimulation on Acute Pancreatitis: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Air Force Military Medical University, China · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Acute pancreatitis (AP), characterized by the sudden onset of pancreatic inflammation, is a frequent gastrointestinal emergency. Early suppression of the inflammatory response is critical to mitigate disease progression. When localized pancreatic inflammation progresses to systemic inflammation, triggering systemic inflammatory response syndrome (SIRS), the condition advances to moderate or severe AP, with mortality rates ranging from 10% to 40%. Additionally, early resumption of enteral nutrition reduces the risk of intra-abdominal infections and organ failure associated with AP. However, gastrointestinal dysfunction, which frequently manifests as gastroparesis or intestinal obstruction in severe cases , significantly complicates AP management by prolonging recovery time and compromising nutritional tolerance. Current early-phase management of AP remains suboptimal: anti-inflammatory strategies are predominantly limited to fluid resuscitation, while gastrointestinal function preservation is frequently underestimated. Consequently, effective therapies targeting both inflammatory suppression and gastrointestinal functional restoration in the early phase of AP are urgently needed. The central nervous system plays a pivotal role in regulating peripheral immune responses, with the vagal anti-inflammatory signaling pathway serving as a key efferent pathway of the inflammatory reflex. Animal studies have shown a protective effect of the vagal anti-inflammatory signaling pathway against AP. Specifically, vagus nerve stimulation (VNS) significantly reduced pancreatic injury and improved survival in mice with severe AP. Furthermore, VNS has shown therapeutic potential in animal models of sepsis, shock, and renal ischemia-reperfusion injury, conditions frequently associated with systemic inflammation in severe pancreatitis. These findings suggest that VNS may alleviate both local and systemic inflammatory responses, as well as their complications. Notably, prior clinical trial revealed that transcutaneous auricular VNS (taVNS) alleviated functional dyspepsia symptoms in adults, indicating its dual capacity for anti-inflammatory effects and gastrointestinal functional modulation. Based on this evidence, the investigators propose a randomized, sham-controlled trial to systematically evaluate the therapeutic efficacy of taVNS in patients with acute pancreatitis .

Conditions

• Acute Pancreatitis (AP)
• Vagus Nerve Stimulations

Interventions

Type	Name	Description
DEVICE	taVNS	Patients will receive taVNS at left tragus (a device developed by the Engineering Research Center of Molecular and Neuro Imaging, Ministry of Education (School of Life Science and Technology, Xidian University), in collaboration with the Wearable BCI and Intelligent Rehabilitation Innovation Lab (Guangzhou Institute of Technology, Xidian University)) twice daily (morning and night) for 30 minutes per session over a period of up to 7 days. The stimulation parameters are as follows: * Duty circle: 30s "on" periods alternating with 30s "off" periods; * Frequency: 25 Hz; * Amplitude: 0-2 mA (adjusted to the maximum tolerated level for each patient); * Pulse width: 0.5 ms.
DEVICE	Sham-taVNS	Patients will receive taVNS at left earlobe (a device developed by the Engineering Research Center of Molecular and Neuro Imaging, Ministry of Education (School of Life Science and Technology, Xidian University), in collaboration with the Wearable BCI and Intelligent Rehabilitation Innovation Lab (Guangzhou Institute of Technology, Xidian University)) twice daily (morning and night) for 30 minutes per session over a period of up to 7 days. The stimulation parameters are as follows: \*Duty circle: 30s "on" periods alternating with 30s "off" periods; \*Frequency: 25 Hz; \*Amplitude: 0-2 mA (adjusted to the maximum tolerated level for each patient); \*Pulse width: 0.5 ms.

Timeline

• Start date: 2025-05-15
• Primary completion: 2025-11-20
• Completion: 2025-12-01
• First posted: 2025-05-31
• Last updated: 2026-03-31

Locations

5 sites across 1 country: China