Home-based Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for IBS Pain

Launched by YALE UNIVERSITY · Feb 20, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a treatment called home-based transcutaneous auricular vagus nerve stimulation (taVNS) to help manage pain and symptoms in young adults with Irritable Bowel Syndrome (IBS). The researchers want to find out if using taVNS at home is safe and if it can effectively reduce IBS-related pain. There will be two groups in the study: one will receive the active taVNS treatment, while the other will receive a sham treatment that feels similar but has minimal effects.

To participate, individuals must be between 18 and 29 years old, have a diagnosis of IBS with moderate pain at least four days a week, and be able to use the internet and read English. Participants will use the taVNS device twice a day for six weeks and keep a diary of their symptoms. They will also visit the research lab at the beginning and end of the study for checkups. This trial is currently not recruiting participants, but it aims to provide valuable insights into a new way to help manage IBS pain at home.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 18 - 29 years of age;
• • Men and women;
• • Diagnosis of IBS from a healthcare provider with current report of pain (volunteers asked to bring provider-verification of IBS diagnosis based on Rome IV criteria to initial study appointment);
• • Experiencing moderate pain (≥3 out of 10 on numeric rating scale \[NRS\]) at least 4 days of the week and lasting previous three months;
• • Daily access to a computer connected to the internet; and
• • Able to read and speak English.
• Exclusion Criteria:
• • Other chronic pain condition;
• • Celiac disease or inflammatory bowel disease;
• • Diabetes mellitus;
• • severe psychiatric condition requiring inpatient treatment in previous 6 months;
• • Pregnancy or lactation;
• • Regular use of opioids or other illicit substances;
• • use of probiotics or antibiotics within 2 weeks from enrollment; and
• • any other conditions/contraindications that prohibit the application of taVNS including but not limited to any current or past history of cardiovascular disorders, recent ear trauma, and metal implants above the level of the neck.