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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
120
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.
Vernon Cottage, Depot Campus
Storrs, Connecticut, United States
RECRUITINGPain 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.
Time frame: 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.
Time frame: 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
Time frame: Baseline and 4-week follow-up
Electrocardiogram (ECG)
ECG will be recorded non-invasively via surface electrodes on an abdominal belt; unit: mV
Time frame: Baseline and 4-week follow-up
Electromyogram (EMG)
EMG will be recorded non-invasively via surface electrodes on an abdominal belt; unit: mV
Time frame: 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.
Time frame: Baseline and 4-week follow-up
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