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Objective Integrated Multimodal Electrophysiological Index for the Quantification of Visceral Pain

NCT06381921 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-09-15

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Yale University

    collaborator OTHER

  • University of Connecticut

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-08
Primary Completion
2027-10-31
Completion
2029-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06381921 on ClinicalTrials.gov