Objective Integrated Multimodal Electrophysiological Index for the Quantification of Visceral Pain

NCT06381921 | Recruiting DMC

• 1 other identifier: B2023-0046
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Pain

Keywords

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

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• Electrodermal activity (EDA)

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

  Baseline and 4-week follow-up

• Electrocardiogram (ECG)

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

  Baseline and 4-week follow-up

• Electromyogram (EMG)

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

  Baseline and 4-week follow-up

• 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

Study Arms (2)

IBS-PPSM intervention group

EXPERIMENTAL

After the baseline visit, the IBS-PPSM group will receive 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. The IBS-PPSM group will be taught to use the abdominal belt/smart watch system for daily recording of bio-signals and voluntary report of episodes of visceral pain. We will follow up with all participants 4 weeks after enrollment, in a final lab visit, and measure primary outcomes to compare to the baseline data.

Behavioral: IBS-PPSM intervention

IBS-control group

NO INTERVENTION

The IBS-control group will not receive pain self-management intervention. Participants will be taught to use the abdominal belt/smart watch system for daily recording of bio-signals and voluntary report of episodes of visceral pain. We will follow up with all participants 4 weeks after enrollment, in a final lab visit, and measure primary outcomes to compare to the baseline data.

Interventions

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.

IBS-PPSM intervention group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Connecticut: lead
• Yale University: collaborator

Study Sites (1)

Vernon Cottage, Depot Campus

Storrs, Connecticut, 06269, United States

RECRUITING

MeSH Terms

Conditions

Abdominal Pain; Visceral Pain; Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Nociceptive Pain; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

Hugo F Posada-Quintero

CONTACT

8604861556; hugo.posada-quintero@uconn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: randomized controlled ambulatory trial

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 24, 2024
• Study Start: September 8, 2025
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): February 28, 2029
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)