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

Abdominal Pain Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06381921
Study type Interventional
Source University of Connecticut
Contact
Status Not yet recruiting
Phase N/A
Start date May 1, 2025
Completion date February 28, 2029
View Details
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