Trans Auricular Vagal Nerve Stimulation in Patients With IBS-C

Randomized Controlled Trial Evaluating Trans Auricular Vagal Nerve Stimulation in Patients With Irritable Bowel Syndrome Constipation Subtype

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.

Inclusion Criteria:

• Referred to the WVU Department of Gastroenterology and Hepatology
• Diagnosis of IBS-C

Exclusion Criteria:

• Failure of second-line therapy with secretagogues (linaclotide, lubiprostone, plecanatide, or tenapanor)
• Failure of third-line therapy with tegaserod
• Known debilitating psychiatric illness
• Cognitive impairment
• Pregnancy
• Prisoners
• Active substance use disorder
• Concurrent opioid use
• History of major gastrointestinal surgery resulting in luminal alteration
• History of vagotomy
• Secondary causes of constipation (e.g., opioid use, uncontrolled hypothyroidism, celiac disease)