Objective Integrated Multimodal Electrophysiological Index for the Quantification of Visceral Pain

Abdominal Pain Clinical Trial

— OIME  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06381921
• Other study ID #: B2023-0046
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2025
• Est. completion date: February 28, 2029

Study information

• Verified date: April 2024
• Source: University of Connecticut
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: February 28, 2029
• Est. primary completion date: October 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Pain
• Visceral Pain

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Connecticut	Yale University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity and interference	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.	Baseline and 4-week follow-up; Weekly Online Logs
Primary	IBS-related symptoms	Qualitative narrative data will be collected including self-reported stool frequency, quality, form, and abdominal bloating or distention symptoms. Online diary format data.	Baseline and 4-week follow-up; Weekly Online Logs
Primary	Electrodermal activity (EDA)	EDA will be recorded non-invasively via surface electrodes on an abdominal belt; unit: µS	Baseline and 4-week follow-up
Primary	Electrocardiogram (ECG)	ECG will be recorded non-invasively via surface electrodes on an abdominal belt; unit: mV	Baseline and 4-week follow-up
Primary	Electromyogram (EMG)	EMG will be recorded non-invasively via surface electrodes on an abdominal belt; unit: mV	Baseline and 4-week follow-up
Primary	Objective integrated multimodal electrophysiological index	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.	Baseline and 4-week follow-up