NCT06381921NARecruitingAccepts Healthy Volunteers

Objective Integrated Multimodal Electrophysiological Index for the Quantification of Visceral Pain

University of Connecticut

Start Date

9/8/2025

Completion Date

2/28/2029

Summary

The objectives of the study are to 1) Conduct telemetric biosignals (EDA, ECG, and EMG) recording in healthy controls and IBS participants experiencing cutaneous and visceral pain; and 2) Validate the OIME index as a biomarker for quantifying pain in IBS participants and its capability to assess the treatment of IBS pain via an ambulatory trial.

Detailed Description

In part 1, data collection for training the OIME model, we will collect autonomic and muscular activities with integrated biosignal device and visceral pain level in both healthy controls and IBS participants. These data will be used to train a machine learning model to produce an objective integrated multimodal electrophysiological (OIME) index. In part 2, the ambulatory trial, we will collect data to validate the OIME index as a biomarker of pain in IBS participants. We will run an ambulatory trial to validate the OIME index as a biomarker to assess the treatment of IBS pain.

Eligibility Criteria

Age Range: 18 years to 50 years

Inclusion Criteria: * Participants need to be diagnosed with IBS by a healthcare provider according to Rome-III or -IV criteria, with a current report of abdominal pain. * Men and women 18-50 years old * Able to read and speak English * Daily access to a computer with internet access. Exclusion Criteria: * Other chronic pains that are usually not comorbid with IBS, e.g., diabetic neuropathy, myofascial pain, low back pain, peripheral neuropathy etc. * Celiac disease or inflammatory bowel disease * Diabetes mellitus; d) Serious mental health conditions * Women during pregnancy or within 3 months post-partum period * Self- reported Regular use of opioids or other illicit substances. * Participants who have had COVID-19 should be fully recovered, and will be asked if their medical provider has made any restriction on activities.

Interventions

BEHAVIORAL

IBS-PPSM intervention

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Conditions

Abdominal Pain

Locations

Vernon Cottage, Depot Campus

Storrs, Connecticut 06269

United States