Objective Integrated Multimodal Electrophysiological Index for the Quantification of Visceral Pain
Recruiting now · Not applicable
Conditions studied: Abdominal Pain
In brief
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.
Key facts
- Study ID
- NCT06381921
- Run by
- University of Connecticut
- People needed
- 120
- Starts
- 2025-09-08
- Expected to finish
- 2029-02-28
- Last updated by the study team
- 2025-09-15
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 it is running
- Vernon Cottage, Depot Campus — Storrs, Connecticut, United States (enrolling)
Full record on ClinicalTrials.gov
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