Objective Integrated Multimodal Electrophysiological Index for the Quantification of Visceral Pain

NCT ID: NCT06381921

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-08
• Study Completion Date: 2029-02-28

Brief 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.

Conditions

Abdominal Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

IBS-PPSM intervention group

After the baseline visit, the IBS-PPSM group will receive 10 video modules focused on IBS knowledge and self-management skills plus one-on-one consultation with a nurse for personalized advice about self-monitoring, diet, sleep, and goal setting. The IBS-PPSM group will be taught to use the abdominal belt/smart watch system for daily recording of bio-signals and voluntary report of episodes of visceral pain. We will follow up with all participants 4 weeks after enrollment, in a final lab visit, and measure primary outcomes to compare to the baseline data.

Group Type: EXPERIMENTAL

IBS-PPSM intervention

Intervention Type: BEHAVIORAL

IBS-PPSM intervention includes 10 video modules focused on IBS knowledge and self-management skills plus one-on-one consultation with a nurse for personalized advice about self-monitoring, diet, sleep, and goal setting.

IBS-control group

The IBS-control group will not receive pain self-management intervention. Participants will be taught to use the abdominal belt/smart watch system for daily recording of bio-signals and voluntary report of episodes of visceral pain. We will follow up with all participants 4 weeks after enrollment, in a final lab visit, and measure primary outcomes to compare to the baseline data.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

IBS-PPSM intervention

IBS-PPSM intervention includes 10 video modules focused on IBS knowledge and self-management skills plus one-on-one consultation with a nurse for personalized advice about self-monitoring, diet, sleep, and goal setting.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yale University

OTHER

Sponsor Role: collaborator

University of Connecticut

OTHER

Sponsor Role: lead

Responsible Party

Hugo Posada-Quintero

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Vernon Cottage, Depot Campus

Storrs, Connecticut, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Hugo F Posada-Quintero

Role: CONTACT

hugo.posada-quintero@uconn.edu

8604861556

Facility Contacts

Maria Groza

Role: primary

maria.groza@uconn.edu

573-529-9499

Stephen Kenton

Role: backup

kenton@easternct.edu

Other Identifiers

B2023-0046

Identifier Type: -

Identifier Source: org_study_id