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NCT Number: NCT06381921

Objective Integrated Multimodal Electrophysiological Index for the Quantification of Visceral Pain

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.

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Key information

Conditions

Abdominal Pain Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Irritable Bowel Syndrome Neurologic Manifestations Nociceptive Pain Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Visceral Pain

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Men and women 18-50 years old
  • Able to read and speak English
  • Daily access to a computer with internet access.

Exclusion criteria

  • Other chronic pains that are usually not comorbid with IBS, e.g., diabetic neuropathy, myofascial pain, low back pain, peripheral neuropathy etc.
  • Celiac disease or inflammatory bowel disease
  • Diabetes mellitus; d) Serious mental health conditions
  • Women during pregnancy or within 3 months post-partum period
  • Self- reported Regular use of opioids or other illicit substances.
  • Participants who have had COVID-19 should be fully recovered, and will be asked if their medical provider has made any restriction on activities.

Treatment and study plan

IBS-PPSM intervention

Behavioral

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.

Primary outcomes

  1. Pain intensity and interference

    Time frame: Baseline and 4-week follow-up; Weekly Online Logs

    Brief Pain Inventory (BPI) scale: the 9-item scale measures pain intensity and interference using 0 - 10 rating scales. Higher score indicates higher levels of pain intensity and interference.

  2. IBS-related symptoms

    Time frame: Baseline and 4-week follow-up; Weekly Online Logs

    Qualitative narrative data will be collected including self-reported stool frequency, quality, form, and abdominal bloating or distention symptoms. Online diary format data.

  3. Electrodermal activity (EDA)

    Time frame: Baseline and 4-week follow-up

    EDA will be recorded non-invasively via surface electrodes on an abdominal belt; unit: µS

  4. Electrocardiogram (ECG)

    Time frame: Baseline and 4-week follow-up

    ECG will be recorded non-invasively via surface electrodes on an abdominal belt; unit: mV

  5. Electromyogram (EMG)

    Time frame: Baseline and 4-week follow-up

    EMG will be recorded non-invasively via surface electrodes on an abdominal belt; unit: mV

  6. Objective integrated multimodal electrophysiological index

    Time frame: Baseline and 4-week follow-up

    Objective integrated multimodal electrophysiological (OIME) index as a biomarker for visceral pain will be generated and validated through integration of surface bio-signal recordings of EDA, ECG, and EMG via a supervised machine-learning algorithm.

Study contacts

Contact information is provided by the study sponsor or research team.

Hugo F Posada-Quintero

CONTACT

[email protected]

8604861556

Sponsors and collaborators

Lead sponsor

University of Connecticut

Other

Collaborators

  • Yale University

Registry information

Official study title

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

Acronym: OIME

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
Apr 24, 2024
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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