NCT06381921

Objective Integrated Multimodal Electrophysiological Index for the Quantification of Visceral Pain

OIME - Objective Integrated Multimodal Electrophysiological Index for the Quantification of Visceral Pain

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: University of Connecticut · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	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.

Timeline

• Start date: 2025-09-08
• Primary completion: 2027-10-31
• Completion: 2029-02-28
• First posted: 2024-04-24
• Last updated: 2025-09-15

Locations

1 site across 1 country: United States