A Study to Evaluate Transcutaneous Auricular Vagus Nerve Stimulation taVNS for Treating Refractory Constipation in Adults

What This Trial Is About

This research aims to find out if transcutaneous auricular vagus nerve stimulation taVNS helps adults with refractory constipation, a condition where constipation does not improve with usual treatments. The study will also examine the safety and tolerability of taVNS. Researchers want to know if taVNS increases the number of complete spontaneous bowel movements per week, reduces the need for rescue laxatives, and what side effects or medical problems may occur during treatment. Participants will be randomly assigned to receive either active taVNS or a sham procedure that looks the same but does not provide real stimulation. Both groups will use the device twice daily for 20 days, with two 30-minute sessions each day spaced about 12 hours apart. The active stimulation is delivered to the left ear at specific settings, while the sham group receives a placebo-like procedure to keep the study blinded. During the trial, participants will keep a daily diary recording bowel habits, symptoms, and use of rescue laxatives. Researchers will monitor changes in bowel movements, symptoms of depression and anxiety, and neurological responses using EEG. The main outcome is how well baseline brain activity predicts response to treatment after 20 days. Safety and side effects will also be tracked, with the total participation lasting about three weeks.

Optimization of taVNS Intervention Strategies for Refractory Constipation