Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06381921
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-24
First Post:
2024-04-17
Brief Title:
Objective Integrated Multimodal Electrophysiological Index for the Quantification of Visceral Pain
Sponsor:
University of Connecticut
Organization:
University of Connecticut
Study Overview
Official Title:
OIME - Objective Integrated Multimodal Electrophysiological Index for the Quantification of Visceral Pain
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OIME
Brief 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 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None