Objective Integrated Multimodal Electrophysiological Index for the Quantification of Visceral Pain

Not Applicable

Not yet recruiting

• Conditions: Abdominal Pain

• Registration Number: NCT06381921
• Lead Sponsor: University of Connecticut

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2024-04-17
• Study First Submitted QC: 2024-04-19
• Study First Posted: 2024-04-24
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-15
• Last Update Posted: 2025-07-18
• Study Start: 2025-08-01
• Primary Completion: 2027-10-31
• Study Completion: 2029-02-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
IBS-related symptoms	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.
Electrocardiogram (ECG)	Baseline and 4-week follow-up	ECG will be recorded non-invasively via surface electrodes on an abdominal belt; unit: mV
Electrodermal activity (EDA)	Baseline and 4-week follow-up	EDA will be recorded non-invasively via surface electrodes on an abdominal belt; unit: µS
Pain intensity and interference	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.
Electromyogram (EMG)	Baseline and 4-week follow-up	EMG will be recorded non-invasively via surface electrodes on an abdominal belt; unit: mV
Objective integrated multimodal electrophysiological index	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.