Recruiting

taVNS vs. Sham taVNS

Sponsor:

Yale University

Code:

NCT06847360

Conditions

Pain, Chronic

Irritable Bowel Syndrome

Symptom Cluster

Eligibility Criteria

Sex: All

Age: 18 - 29

Healthy Volunteers: Not accepted

Interventions

Home-based taVNS intervention

Study Details

Brief 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

Study ID

NCT06847360

Start date

Jan 19, 2026

Status verified date

Apr, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 29

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active taVNS intervention

Active taVNS twice daily, 30 minutes per session, over 6 weeks.

sham comparator: Sham taVNS

Sham taVNS twice daily, 30 minutes per session, over 6 weeks.

Interventions

Home-based taVNS intervention

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

Primary outcome measure

  • Feasibility of implementing taVNS - Retention rates [ Time Frame: Baseline, week 6, week 12 ]
  • Adherence of implementing taVNS - Duration of usage [ Time Frame: week 6 ]
  • Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: Baseline, week 6, week 12 ]
  • Satisfaction in implementing taVNS [ Time Frame: Baseline, week 6, week 12 ]
  • Change in pain intensity assessed using the Brief Pain Inventory (BPI) [ Time Frame: Baseline, week 6 and week 12 ]
  • Changes in IBS symptoms using IBS Symptom Severity Scale (IBS-SSS) [ Time Frame: Baseline, week 6, week 12 ]
  • Changes in IBS-related Psychophysiological Symptoms - Anxiety using Patient-Reported Outcomes Measurement Information System (PROMIS®) Anxiety 4a [ Time Frame: Baseline, week 6, week 12 ]
  • Changes in IBS-related Psychophysiological Symptoms - Fatigue using Patient-Reported Outcomes Measurement Information System (PROMIS®) Fatigue 4a [ Time Frame: Baseline, week 6, week 12 ]
  • Changes in IBS-related Psychophysiological Symptoms - Depression using Patient-Reported Outcomes Measurement Information System (PROMIS®) Depression 4a [ Time Frame: Baseline, week 6, week 12 ]
  • Changes in IBS-related Psychophysiological Symptoms - Applied Cognition using Patient-Reported Outcomes Measurement Information System (PROMIS®) Applied Cognition Abilities 4a [ Time Frame: Baseline, week 6, week 12 ]
  • Changes in IBS-related Psychophysiological Symptoms - Sleep using Patient-Reported Outcomes Measurement Information System (PROMIS®) Sleep Disturbance 4a [ Time Frame: Baseline, week 6, week 12 ]
  • Changes in IBS related psychosocial factors - Stress using Perceived Stress Scale-10 (PSS-10) [ Time Frame: Baseline, week 6, week 12 ]
  • Changes in IBS-related quality of life using IBS-Quality of Life (IBS-QOL) Questionnaire [ Time Frame: Baseline, week 6, week 12 ]
  • Changes in IBS related psychosocial factors - Self-Efficacy using IBS Self-Efficacy Scale (IBS-SE) [ Time Frame: Baseline, week 6, week 12 ]
  • Changes in IBS related psychosocial factors - Pain Catastrophizing using Brief Pain Catastrophizing Scale (Brief-PCS) [ Time Frame: Baseline, week 6, week 12 ]
  • Changes in IBS related psychosocial factors - Coping using Coping Strategies Questionnaire-Revised (CSQ-R) [ Time Frame: Baseline, week 6, week 12 ]
  • Changes in IBS related psychosocial factors - Emotion Regulation using Difficulties in Emotion Regulation Scale (DERS) [ Time Frame: Baseline, week 6, week 12 ]

Central Contacts and Locations

Central contacts

Xiaomei S Cong, PhD

8606179849xiaomei.cong@yale.edu

Jie Chen, PhD

850-645-0657jc22db@fsu.edu

Locations

Yale University

Recruiting

New Haven, Connecticut, United States, 06511

Contacts

Jie Chen, PhD

850-645-0657jc22db@fsu.edu

Principal Investigator:

Jie Chen, PhD

More Information

Sponsor

Yale University

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-04-13.