Multi Modal Imaging: An MRI Study to Investigate Differences in the Structure and the Function of the Brain at Rest. (MMI)
| Tracking Information | |||||||||
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| First Received Date ICMJE | December 14, 2011 | ||||||||
| Last Updated Date | January 20, 2012 | ||||||||
| Start Date ICMJE | March 2011 | ||||||||
| Estimated Primary Completion Date | August 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Resting state networks [ Time Frame: within 1 week of scanning visit ] [ Designated as safety issue: No ] 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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01517516 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Multi Modal Imaging: An MRI Study to Investigate Differences in the Structure and the Function of the Brain at Rest. | ||||||||
| Official Title ICMJE | 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 or IBD and Healthy Controls | ||||||||
| 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 (in this study: IBS) 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. The overall goal is to identify structural and functional brain abnormalities in patients with chronic pain conditions, such as Irritable Bowel Syndrome (IBS), Functional Dyspepsia (FD), Cyclical Vomiting Syndrome (CVs), Non Cardiac Chest Pain (NCCP) or Inflammatory Bowel Disease (IBD), and comparing those differences between conditions; and matched healthy control subjects. |
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| Detailed Description | The study involves 2 visits. The screening visit is about 90 minutes and involves signing the consent, completing questionnaires, a medical history and 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. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | Subjects will be recruited from clinics, community in and around Los Angeles Area. |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 240 | ||||||||
| Estimated Completion Date | August 2013 | ||||||||
| Estimated Primary Completion Date | August 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Men and women who meet the following criteria are eligible for inclusion in the study:
12. Diagnosed with IBD and currently not taking steroid therapy. 13. Diagnosed with vestibulodynia (a subgroup of vulvodynia) Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 55 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01517516 | ||||||||
| Other Study ID Numbers ICMJE | 11-000069, RO1 DKO48351 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Emeran Mayer, MD, University of California, Los Angeles | ||||||||
| Study Sponsor ICMJE | University of California, Los Angeles | ||||||||
| Collaborators ICMJE | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of California, Los Angeles | ||||||||
| Verification Date | January 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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