Objective Integrated Multimodal Electrophysiological Index for the Quantification of Visceral Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: IBS-PPSM intervention.
- Who it may be relevant to
- Registry conditions: Abdominal Pain. Basic parameters: 18 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
OIME - Objective Integrated Multimodal Electrophysiological Index for the Quantification of Visceral Pain
Overview
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.
Interventions
- 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.
Primary outcome measures
- Pain intensity and interference [Time frame: Baseline and 4-week follow-up; Weekly Online Logs]
- IBS-related symptoms [Time frame: Baseline and 4-week follow-up; Weekly Online Logs]
- Electrodermal activity (EDA) [Time frame: Baseline and 4-week follow-up]
- Electrocardiogram (ECG) [Time frame: Baseline and 4-week follow-up]
- Electromyogram (EMG) [Time frame: Baseline and 4-week follow-up]
- Objective integrated multimodal electrophysiological index [Time frame: Baseline and 4-week follow-up]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Vernon Cottage, Depot Campus — Storrs
Identifiers
NCT: NCT06381921 · B2023-0046