RECRUITING

Objective Integrated Multimodal Electrophysiological Index for the Quantification of Visceral Pain

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Conditions

Abdominal Painvisceral painirritable bowel syndromeautonomic and muscular activitiesbiosignalspersonalized pain self-management

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-09-08
Study Completion:2029-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06381921

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Men and women 18-50 years old
  3. * Able to read and speak English
  4. * Daily access to a computer with internet access.
  1. * Other chronic pains that are usually not comorbid with IBS, e.g., diabetic neuropathy, myofascial pain, low back pain, peripheral neuropathy etc.
  2. * Celiac disease or inflammatory bowel disease
  3. * Diabetes mellitus; d) Serious mental health conditions
  4. * Women during pregnancy or within 3 months post-partum period
  5. * Self- reported Regular use of opioids or other illicit substances.
  6. * Participants who have had COVID-19 should be fully recovered, and will be asked if their medical provider has made any restriction on activities.

Contacts and Locations

Study Contact

Hugo F Posada-Quintero
CONTACT
8604861556
hugo.posada-quintero@uconn.edu

Study Locations (Sites)

Vernon Cottage, Depot Campus
Storrs, Connecticut, 06269
United States

Collaborators and Investigators

Sponsor: University of Connecticut

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-08
Study Completion Date2029-02-28

Study Record Updates

Study Start Date2025-09-08
Study Completion Date2029-02-28

Terms related to this study

Keywords Provided by Researchers

  • visceral pain
  • irritable bowel syndrome
  • autonomic and muscular activities
  • biosignals
  • personalized pain self-management

Additional Relevant MeSH Terms

  • Abdominal Pain