Optimization of taVNS Intervention Strategies for Refractory Constipation

The goal of this clinical trial is to learn whether transcutaneous auricular vagus nerve stimulation (taVNS) works to treat refractory constipation in adults. It will also learn about the safety and tolerability of taVNS. The main questions it aims to answer are: Does taVNS improve constipation symptoms, as measured by the change in complete spontaneous bowel movements per week (ΔCSBMs/week) from baseline to post-treatment? What medical problems or side effects do participants have when receiving taVNS? Does taVNS reduce the need for rescue laxatives? Researchers will compare active taVNS to sham taVNS to see if taVNS works to treat refractory constipation. Participants will: Be randomly assigned (double-blind) to receive active taVNS or sham taVNS for 20 days Receive stimulation twice daily, 30 minutes per session, with a 12-hour interval between sessions Receive stimulation at 30 Hz with 200 μs pulse width, delivered to the left cymba conchae Keep a daily diary of bowel habits and symptoms, including CSBMs, and rescue laxative use (bowel movements occurring within 24 hours after rescue laxative use will not be counted as CSBMs)

NCT Number	NCT07344402
Lead Sponsor	Xijing Hospital of Digestive Diseases
Conditions	Refractory Constipation
Enrollment	100 participants
Start Date	2025-09-01
Primary Completion	2026-01-20 (estimated)
Study Completion	2026-01-20 (estimated)
Updated on ClinicalTrials.gov	2026-01-15