Objective Integrated Multimodal Electrophysiological Index for the Quantification of Visceral Pain (OIME)

University of Connecticut

Status: Enrolling

Conditions: Abdominal Pain

Treatments: Behavioral: IBS-PPSM intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06381921

B2023-0046

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

IBS-PPSM intervention group

Experimental group

Description:

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.

Treatment:

Behavioral: IBS-PPSM intervention

IBS-control group

No Intervention group

Description:

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.