Multi Modal Imaging: An MRI Study to Investigate Differences in the Structure and the Function of the Brain at Rest. (MMI)
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|ClinicalTrials.gov Identifier: NCT01517516|
Recruitment Status : Completed
First Posted : January 25, 2012
Last Update Posted : January 14, 2016
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.
|Condition or disease|
|Irritable Bowel Syndrome Cyclical Vomiting Syndrome Ulcerative Colitis Vulvodynia Crohn's Disease|
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 Type :||Observational|
|Actual Enrollment :||165 participants|
|Observational Model:||Case Control|
|Official Title:||A Magnetic Resonance Imaging (MRI) Study to Investigate Differences in the Structure and the Function of the Brain at Rest; Between Persons With Functional Pain Conditions Such as IBS or Vulvodynia, IBD and Healthy Controls|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
Functional Pain Conditions and Inflammatory bowel disease
Cyclical Vomiting Syndrome, Irritable Bowel Syndrome, Inflammatory Bowel disease (Ulcerative colitis and Crohns)and Vulvodynia (vestibulodynia)
Inflammatory Bowel Disease
Subjects diagnosed with Crohn's Disease or Ulcerative Colitis.
- Resting state networks [ Time Frame: within 1 week of scanning visit ]The resting state functional MRI scan will be done to assess differences in the resting state networks in subjects with chronic pain conditions in comparison to healthy controls.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01517516
|United States, California|
|Gail and Gerald Oppenheimer Family Center for Neurobiology of Stress|
|Los Angeles, California, United States, 90095|
|Principal Investigator:||Emeran Mayer, MD||University of California, Los Angeles|