Abdominal PainOIMENCT06381921
Objective Integrated Multimodal Electrophysiological Index for the Quantification of Visceral Pain
A study testing IBS-PPSM intervention in people with Abdominal Pain, run by University of Connecticut at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Abdominal Pain
- What is being tested?
- IBS-PPSM intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2025to 28 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Vernon Cottage, Depot Campus
Storrs, Connecticut, 06269
Maria Groza, 573-529-9499, maria.groza@uconn.edu
Stephen Kenton, kenton@easternct.edu
About this study
Official title: OIME - Objective Integrated Multimodal Electrophysiological Index for the Quantification of Visceral Pain
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.
Read the 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.
- Conditions
- Abdominal Pain
- Being tested
- IBS-PPSM intervention
- Keywords
- visceral pain, irritable bowel syndrome, autonomic and muscular activities, biosignals, personalized pain self-management
- Medical subject headings
- Abdominal Pain, Visceral Pain, Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBS-PPSM interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| IBS-PPSM intervention group | Experimental | 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. Receives: Behavioral: IBS-PPSM intervention |
| IBS-control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain 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.
Measured: 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.
Measured: 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
Measured: Baseline and 4-week follow-up
Electrocardiogram (ECG)
ECG will be recorded non-invasively via surface electrodes on an abdominal belt; unit: mV
Measured: Baseline and 4-week follow-up
Electromyogram (EMG)
EMG will be recorded non-invasively via surface electrodes on an abdominal belt; unit: mV
Measured: 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.
Measured: Baseline and 4-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start8 Sep 2025
- Primary completion31 Oct 2027 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled ambulatory trial
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Collaborators
- Yale University
- Responsible party
- Principal investigator, Hugo Posada-Quintero, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06381921
- Sponsor's protocol ID
- B2023-0046
- Acronym
- OIME
- Status last verified
- Sep 2025
- First submitted
- 17 Apr 2024
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OIME - Objective Integrated Multimodal Electrophysiological Index for the Quantification of Visceral Pain
- ClinicalTrials.gov ID
- NCT06381921
- Acronym / sponsor ID
- OIME / B2023-0046
- Conditions
- Abdominal Pain
- Keywords
- visceral pain, irritable bowel syndrome, autonomic and muscular activities, biosignals, personalized pain self-management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Collaborators
- Yale University
- Study start
- 8 Sep 2025 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 24 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized controlled ambulatory trial
| Arm | Type | Receives |
|---|---|---|
| IBS-PPSM intervention group | Experimental | Behavioral: IBS-PPSM interventionAfter 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. |
| IBS-control group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IBS-PPSM interventionIBS-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. | Behavioural | IBS-PPSM intervention group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IBS-PPSM intervention in people with Abdominal Pain, run by University of Connecticut at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hugo F Posada-Quintero (8604861556, hugo.posada-quintero@uconn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity and interference (time frame: Baseline and 4-week follow-up; Weekly Online Logs). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.