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Trans Auricular Vagal Nerve Stimulation in Patients With IBS-C
Sponsor: West Virginia University
Summary
This study evaluates the efficacy and safety of transcutaneous auricular vagus nerve stimulation (ta-VNS) in adults with constipation-predominant irritable bowel syndrome (IBS-C). Participants will be randomized to receive either active or sham stimulation using a non-invasive auricular device over a 60-day period. The primary objectives are to assess changes in symptom severity and quality of life using validated instruments, including the IBS Symptom Severity Scale (IBS-SSS) and the IBS Quality of Life questionnaire (IBS-QOL). Secondary assessments include safety and participant compliance. This study aims to determine whether ta-VNS is an effective non-invasive therapeutic modality for improving symptoms and quality of life in patients with IBS-C.
Official title: Randomized Controlled Trial Evaluating Trans Auricular Vagal Nerve Stimulation in Patients With Irritable Bowel Syndrome Constipation Subtype
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2026-07
Completion Date
2027-07
Last Updated
2026-06-23
Healthy Volunteers
No
Conditions
Interventions
Transcutaneous Auricular Vagus Nerve Stimulation (ta-VNS)
Delivery of non-invasive electrical stimulation to the auricular branch of the vagus nerve using the Parasym device. Stimulation is applied via an ear clip at 25 Hz and 250 microseconds, with intensity titrated to just below discomfort (0-36 mA). Administered for 30 minutes daily over 60 days.
Sham Transcutaneous Auricular Vagus Nerve Stimulation
Use of a sham Parasym device that mimics active stimulation but delivers only a brief, low-level output at session onset before ramping down to zero for the remainder of the 30-minute session. Administered daily for 60 days to maintain participant blinding.
Locations (1)
West Virginia University- Gastroenterology and Hepatology
Morgantown, West Virginia, United States