Clinical trial NCT06381921: Objective Integrated Multimodal Electrophysiological Index for the Quantification of Visceral Pain
Official title: OIME - Objective Integrated Multimodal Electrophysiological Index for the Quantification of Visceral Pain
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Abdominal Pain
Keywords: visceral pain
irritable bowel syndrome
autonomic and muscular activities
biosignals
personalized pain self-management
Lead sponsor: University of Connecticut
Sponsor class: OTHER
Collaborators: name: Yale University
First posted: 2024-04-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled ambulatory trial
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain intensity and interference
timeFrame: Baseline and 4-week follow-up; Weekly Online Logs
measure: IBS-related symptoms
timeFrame: Baseline and 4-week follow-up; Weekly Online Logs
measure: Electrodermal activity (EDA)
timeFrame: Baseline and 4-week follow-up
measure: Electrocardiogram (ECG)
timeFrame: Baseline and 4-week follow-up
measure: Electromyogram (EMG)
timeFrame: Baseline and 4-week follow-up
measure: Objective integrated multimodal electrophysiological index
timeFrame: Baseline and 4-week follow-up
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: