OIME - Objective Integrated Multimodal Electrophysiological Index for the Quantification of Visceral Pain
University of Connecticut
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.
Eligibility
- Age range
- 18–50 years
- Sex
- All
- Healthy volunteers
- Yes
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 mo…
Interventions
- BehavioralIBS-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.
Location
- Vernon Cottage, Depot CampusStorrs, Connecticut