Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
NCT ID:
NCT01517516
Brief Summary:
The structural/RSN study involves Structural and Resting State Neuroimaging. The purpose of Structural Neuroimaging is to use MRI technology to identify cortical and white matter morphometric differences between patients with chronic pain conditions and healthy control subjects.
The purpose of the Resting State Neuroimaging study is to use functional MRI to identify possible disease related differences in various resting state networks in the brain.
In addition we are looking at the effect gut microbiota on brain function in healthy and IBS participants.
The overall goal is to identify structural and functional brain differences in persons with chronic pain conditions such as Irritable Bowel Syndrome (IBS, Cyclical Vomiting Syndrome(CVS) and vestibulodynia/vulvodynia. We are also looking at Inflammatory Bowel Disease(ulcerative colitis and Crohn's disease. We will be comparing differences between these conditions and matched healthy control subjects.
Detailed Description:
The study involves 2 visits. The screening visit is about 90 minutes and involves signing the consent, completing questionnaires, a medical history, modified physical exam and psychological interview to identify stressors, anxiety, depression and other conditions.
The second visit is the MRI visit (both functional and structural) and also will take about 90 minutes, with the scanning lasting about 45 minutes. There are questionnaires and a measure of skin conductance also.
We have added a single stool sample for microbiota analysis and a food frequency questionnaire in the healthy control and IBS populations.
Study:
NCT01517516
Study Brief:
Protocol Section:
NCT01517516