NCT06381921 · University of Connecticut
Objective Integrated Multimodal Electrophysiological Index for the Quantification of Visceral Pain
(OIME)
What this study is 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.
View original scientific description
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.
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
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.
IBS-related symptoms
Time frame: Baseline and 4-week follow-up; Weekly Online Logs
Qualitative narrative data will be collected including self-reported stool frequency, quality, form, and abdominal bloating or distention symptoms. Online diary format data.
Electrodermal activity (EDA)
Time frame: Baseline and 4-week follow-up
EDA will be recorded non-invasively via surface electrodes on an abdominal belt; unit: µS
Electrocardiogram (ECG)
Time frame: Baseline and 4-week follow-up
ECG will be recorded non-invasively via surface electrodes on an abdominal belt; unit: mV
Electromyogram (EMG)
Time frame: Baseline and 4-week follow-up
EMG will be recorded non-invasively via surface electrodes on an abdominal belt; unit: mV
Objective integrated multimodal electrophysiological index
Time frame: Baseline and 4-week follow-up
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Storrs, Connecticut
Collaborators
Yale University
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 15, 2025 · Source of record for eligibility and locations