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Home-based taVNS for IBS Pain in Young Adults

This study is testing a home-based device called the Parasym system (taVNS, or transcutaneous auricular vagus nerve stimulation) for young adults aged 18-29 who have Irritable Bowel Syndrome (IBS) with moderate chronic pain. The main goal is to see if using this device at home is practical and safe for managing IBS pain and symptoms. Researchers will compare the active taVNS device to a sham (look-alike) device to understand if the active treatment helps. They will also learn about participants' experiences using the device. This study aims to enroll 80 participants, but its current recruitment status is unclear.

Study design
This is a pilot randomized controlled study with two groups (active taVNS or sham taVNS) and plans to enroll 80 participants.
What's involved
You would participate in a 2-week baseline period, followed by 6 weeks of treatment using the taVNS device twice daily for 30 minutes per session, and then a 6-week follow-up period.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 6 weeks after the treatment period ends.

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NCT06847360

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

Recruiting
NAAges 18–29InterventionalTreatment
Yale University
~80 participants
Updated 2026-04-13 on ClinicalTrials.gov
What's tested:Home-based taVNS intervention

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility of implementing taVNS - Retention rates
Measured over Baseline, week 6, week 12
+16 more outcomes measured

Conditions

Pain, Chronic
Irritable Bowel Syndrome
Symptom Cluster

Explore related trials

Chronic PainIrritable Bowel Syndrome

Where it's being run

1 sites across 1 states
Connecticut1

Study leadership

  • Xiaomei S Cong · PRINCIPAL_INVESTIGATOR · Yale University

Who to contact

Xiaomei S Cong, PhD
[email protected]
8606179849
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Feasibility of implementing taVNS - Retention ratesBaseline, week 6, week 12

    Feasibility will be assessed by evaluating the retention rate of participants who complete the taVNS sessions at 6 weeks and the follow-up at week 12. Retention rates will be calculated by comparing the number of participants who complete these timepoints with the baseline data.

  • Adherence of implementing taVNS - Duration of usageweek 6

    Adherence will be measured using participant self-report data and the data from the taVNS monitoring system. Actual usage time (minutes) will be extracted from the Parasym system recorder to monitor the adherence to the study protocol.

  • Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)Baseline, week 6, week 12

    Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) in using the taVNS will be measured using self-reported data, including online self-monitoring diary, weekly meetings with the research team, surveys, and focus group interviews. Adverse events (AEs) will be monitored daily using the online diary with a preset form, including a 10-item survey to assess daily AEs of taVNS on 0-10 Likert scales.

  • Satisfaction in implementing taVNSBaseline, week 6, week 12

    Satisfaction in using the taVNS will be measured using self-reported data including online self-monitoring diary, weekly meetings with the research team, surveys, and focus group interviews.

  • Change in pain intensity assessed using the Brief Pain Inventory (BPI)Baseline, week 6 and week 12

    The BPI has a total score range of 0-10 where: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-10 = severe pain. Total pain severity score can be found by averaging all items.

  • Changes in IBS symptoms using IBS Symptom Severity Scale (IBS-SSS)Baseline, week 6, week 12

    IBS Symptom Severity Scale (IBS-SSS) will be used to measure IBS symptom severity using 100-point scales on five items: severity of abdominal pain, frequency of abdominal pain, severity of abdominal distension, dissatisfaction with bowel habits, and interference with quality of life.

  • Changes in IBS-related Psychophysiological Symptoms - Anxiety using Patient-Reported Outcomes Measurement Information System (PROMIS®) Anxiety 4aBaseline, week 6, week 12

    IBS-related Psychophysiological Symptoms - Anxiety will be measured using Patient-Reported Outcomes Measurement Information System (PROMIS®) Anxiety 4a measuring for Anxiety. Raw scores range from 4 to 20, with T-scores ranging from 40.3±6.1 to 81.6±3.7. A higher PROMIS T-score represents more of the concept being measured.

  • Changes in IBS-related Psychophysiological Symptoms - Fatigue using Patient-Reported Outcomes Measurement Information System (PROMIS®) Fatigue 4aBaseline, week 6, week 12

    IBS-related Psychophysiological Symptoms will be measured using Patient-Reported Outcomes Measurement Information System (PROMIS®) Fatigue 4a measuring for Fatigue. Raw scores range from 4 to 20, with T-scores ranging from 33.7±4.9 to 75.8±3.9. A higher PROMIS T-score represents more of the concept being measured.

  • Changes in IBS-related Psychophysiological Symptoms - Depression using Patient-Reported Outcomes Measurement Information System (PROMIS®) Depression 4aBaseline, week 6, week 12

    IBS-related Psychophysiological Symptoms will be measured using Patient-Reported Outcomes Measurement Information System (PROMIS®) measuring for Depression. Raw scores range from 4 to 20, with T-scores ranging from 41.0±6.2 to 70.4±2.6. A higher PROMIS T-score represents more of the concept being measured.

  • Changes in IBS-related Psychophysiological Symptoms - Applied Cognition using Patient-Reported Outcomes Measurement Information System (PROMIS®) Applied Cognition Abilities 4aBaseline, week 6, week 12

    IBS-related Psychophysiological Symptoms will be measured using Patient-Reported Outcomes Measurement Information System (PROMIS®) measuring for Applied Cognition. Raw scores range from 4 to 20, with T-scores ranging from 30.1± 4.44 to 63.8±5.2. A higher PROMIS T-score represents more of the concept being measured.

  • Changes in IBS-related Psychophysiological Symptoms - Sleep using Patient-Reported Outcomes Measurement Information System (PROMIS®) Sleep Disturbance 4aBaseline, week 6, week 12

    IBS-related Psychophysiological Symptoms will be measured using Patient-Reported Outcomes Measurement Information System (PROMIS®) Sleep Disturbance 4a measuring for sleep disturbance. Raw scores range from 4 to 20, with T-scores ranging from 32.0±5.2 to 73.3±4.6. A higher PROMIS T-score represents more of the concept being measured.

  • Changes in IBS related psychosocial factors - Stress using Perceived Stress Scale-10 (PSS-10)Baseline, week 6, week 12

    IBS related psychosocial factors - stress will be measured using Perceived Stress Scale-10 (PSS-10). The scale consists of 10 items each rated on a 5-point rating scale from "never" to "very often." The sum score ranges from 0 to 40, where a higher score indicates a higher level of stress.

  • Changes in IBS-related quality of life using IBS-Quality of Life (IBS-QOL) QuestionnaireBaseline, week 6, week 12

    IBS-related quality of life will be measured using IBS-Quality of Life (IBS-QOL) Questionnaire. The IBS-QOL consists of 34 self-report items and a five-point Likert scale (0 to 4) is used to measure participants' feelings. The total scores are calculated as the sum of all item scores ranging from 0 to 136 and higher scores show better QOL.

  • Changes in IBS related psychosocial factors - Self-Efficacy using IBS Self-Efficacy Scale (IBS-SE)Baseline, week 6, week 12

    IBS Self-Efficacy Scale (IBS-SE) will be used to measure patients' confidence in their ability to manage IBS abdominal pain and episodes using a 7-point Likert scale on 25 items. The sum of the items derives a total score ranging from 25 to 175. Higher scores indicate higher levels of self-efficacy for IBS symptom control and management.

  • Changes in IBS related psychosocial factors - Pain Catastrophizing using Brief Pain Catastrophizing Scale (Brief-PCS)Baseline, week 6, week 12

    Brief Pain Catastrophizing Scale (Brief-PCS) will be used to measure the perception of pain catastrophizing, which includes 4-item brief version of the PCS, using 5-point scale. The Brief-PCS has a score range 0-16 and higher scores indicate a higher level of catastrophizing.

  • Changes in IBS related psychosocial factors - Coping using Coping Strategies Questionnaire-Revised (CSQ-R)Baseline, week 6, week 12

    Coping Strategies Questionnaire-Revised (CSQ-R) will be used to measure coping strategies in managing IBS-related pain. It is a 27-item questionnaire designed to assess six cognitive coping responses to pain. Subjects rate the frequency of using each coping strategy and perceived control over their pain on a 7-point Likert-type scale (0-6). Total scores range from 0 to 162 with higher scores indicating greater use of coping strategies.

  • Changes in IBS related psychosocial factors - Emotion Regulation using Difficulties in Emotion Regulation Scale (DERS)Baseline, week 6, week 12

    Difficulties in Emotion Regulation Scale (DERS) will be used to measure IBS related emotion regulation. DERS is a 36-itme self-report measure of individuals' abilities to respond to emotional experience in a goal-oriented manner, using a 5-point Likert scale. Total scores range from 36 to 180, with higher scores indicating greater difficulties in emotion regulation.