Clinical trial NCT06847360: Home-based Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for IBS Pain
Official title: Home-Based Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for Pain and Symptom Management Among Young Adults With Irritable Bowel Syndrome (IBS)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pain, Chronic
Irritable Bowel Syndrome
Symptom Cluster
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Florida State University
name: Rutgers University
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2025-02-26
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This pilot randomized controlled study aims to evaluate the feasibility, acceptability, adherence, safety, and potential implementation barriers of home-based taVNS intervention in YAs (18-29 years old) diagnosed with IBS. A two-site, two-arm, parallel, proof-of-concept randomized trial will be conducted to assess the feasibility of using the Active taVNS intervention compared with Sham taVNS in managing IBS-related pain and symptoms. Eighty YAs meeting the Rome IV diagnostic criteria of IBS will be recruited and receive either Active or Sham taVNS for pain and symptom management, along with self-management education and their usual treatment and care. After enrollment and a 2-week baseline run-in period, participants will be randomized to the Active or Sham taVNS with a 6-week treatment (30 minutes per session, twice daily for 6 weeks) and be followed up for another 6 weeks of post-treatment. Investigators will assess feasibility through recruitment rates, adherence, factors influencing adherence, safety, satisfaction, and collection of patient-reported outcomes.

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.

Primary outcomes:
measure: Feasibility of implementing taVNS - Retention rates
timeFrame: Baseline, week 6, week 12
measure: Adherence of implementing taVNS - Duration of usage
timeFrame: week 6
measure: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
timeFrame: Baseline, week 6, week 12
measure: Satisfaction in implementing taVNS
timeFrame: Baseline, week 6, week 12
measure: Change in pain intensity assessed using the Brief Pain Inventory (BPI)
timeFrame: Baseline, week 6 and week 12
measure: Changes in IBS symptoms using IBS Symptom Severity Scale (IBS-SSS)
timeFrame: Baseline, week 6, week 12
measure: Changes in IBS-related Psychophysiological Symptoms - Anxiety using Patient-Reported Outcomes Measurement Information System (PROMIS®) Anxiety 4a
timeFrame: Baseline, week 6, week 12
measure: Changes in IBS-related Psychophysiological Symptoms - Fatigue using Patient-Reported Outcomes Measurement Information System (PROMIS®) Fatigue 4a
timeFrame: Baseline, week 6, week 12
measure: Changes in IBS-related Psychophysiological Symptoms - Depression using Patient-Reported Outcomes Measurement Information System (PROMIS®) Depression 4a
timeFrame: Baseline, week 6, week 12
measure: Changes in IBS-related Psychophysiological Symptoms - Applied Cognition using Patient-Reported Outcomes Measurement Information System (PROMIS®) Applied Cognition Abilities 4a
timeFrame: Baseline, week 6, week 12
measure: Changes in IBS-related Psychophysiological Symptoms - Sleep using Patient-Reported Outcomes Measurement Information System (PROMIS®) Sleep Disturbance 4a
timeFrame: Baseline, week 6, week 12
measure: Changes in IBS related psychosocial factors - Stress using Perceived Stress Scale-10 (PSS-10)
timeFrame: Baseline, week 6, week 12
measure: Changes in IBS-related quality of life using IBS-Quality of Life (IBS-QOL) Questionnaire
timeFrame: Baseline, week 6, week 12
measure: Changes in IBS related psychosocial factors - Self-Efficacy using IBS Self-Efficacy Scale (IBS-SE)
timeFrame: Baseline, week 6, week 12
measure: Changes in IBS related psychosocial factors - Pain Catastrophizing using Brief Pain Catastrophizing Scale (Brief-PCS)
timeFrame: Baseline, week 6, week 12
measure: Changes in IBS related psychosocial factors - Coping using Coping Strategies Questionnaire-Revised (CSQ-R)
timeFrame: Baseline, week 6, week 12
measure: Changes in IBS related psychosocial factors - Emotion Regulation using Difficulties in Emotion Regulation Scale (DERS)
timeFrame: Baseline, week 6, week 12
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Xiaomei S Cong
role: PRINCIPAL_INVESTIGATOR
References: