Actively Recruiting

Phase Not Applicable
Age: 18Years - 50Years
All Genders
Healthy Volunteers
NCT06381921

Objective Integrated Multimodal Electrophysiological Index for the Quantification of Visceral Pain

Led by University of Connecticut · Updated on 2025-09-15

120

Participants Needed

1

Research Sites

181 weeks

Total Duration

On this page

Sponsors

U

University of Connecticut

Lead Sponsor

Y

Yale University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Objective Integrated Multimodal Electrophysiological Index for the Quantification of Visceral Pain

Who Can Participate

Age: 18Years - 50Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with IBS by a healthcare provider using Rome-III or Rome-IV criteria, with current abdominal pain
  • Men and women aged 18 to 50 years
  • Able to read and speak English
  • Have daily access to a computer with internet
Not Eligible

You will not qualify if you...

  • Other chronic pains not usually linked to IBS, such as diabetic neuropathy, myofascial pain, low back pain, or peripheral neuropathy
  • Celiac disease or inflammatory bowel disease
  • Diabetes mellitus
  • Serious mental health conditions
  • Women who are pregnant or within 3 months postpartum
  • Regular use of opioids or illicit substances
  • Participants who had COVID-19 must be fully recovered and have no medical restrictions on activities

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Vernon Cottage, Depot Campus

Storrs, Connecticut, United States, 06269

Actively Recruiting

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Research Team

H

Hugo F Posada-Quintero

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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