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

NCT06847360 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-04-13

No results posted yet for this study

Summary

The goal of this clinical trial is to learn the feasibility and safety of using home-based taVNS in young adults with IBS to manage their IBS-related pain and symptoms. It will also learn about participants' experience in using the home-based taVNS intervention. The main questions it aims to answer are:

* Is it feasible to use a home-based taVNS intervention for pain and symptom management among YAs with IBS?
* Is it safe and reported satisfactory to use a home-based taVNS intervention for pain and symptom management among YAs with IBS? Researchers will compare Active to Sham taVNS (a look-alike intervention that contains minimal stimulation) to see if Active taVNS works on managing IBS-related pain and symptoms.

Participants will:

* Take Active or Sham taVNS intervention for a 6-week treatment (twice daily, 30 minutes per session)
* Visit the research lab at the initial setup and the end of the 6-week treatment for checkups and tests
* Keep a diary of their symptoms and the number of times they use the taVNS.

Conditions

  • Pain, Chronic
  • Irritable Bowel Syndrome
  • Symptom Cluster

Interventions

DEVICE

Home-based taVNS intervention

Home-based taVNS intervention will be administered using the non-invasive taVNS device, Parasym system (Parasym Health, Inc, London, UK).

Sponsors & Collaborators

  • Florida State University

    collaborator OTHER

  • Rutgers University

    collaborator OTHER

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH

  • Yale University

    lead OTHER

Principal Investigators

  • Xiaomei S Cong · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
29 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-19
Primary Completion
2027-09-30
Completion
2028-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06847360 on ClinicalTrials.gov