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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Purpose
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.
| Condition |
|---|
|
Irritable Bowel Syndrome Non Cardiac Chest Pain Cyclical Vomiting Syndrome Functional Dyspepsia Gastroparesis Ulcerative Colitis Vulvodynia Crohn's Disease |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Cross-Sectional |
| 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 or IBD and Healthy Controls |
- 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.
| Estimated Enrollment: | 240 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Functional Pain Conditions and Inflammatory bowel disease
Cyclical Vomiting Syndrome, Irritable Bowel Syndrome, Non-Cardiac Chest Pain, Functional Dyspepsia, Inflammatory Bowel disease, vulvodynia
|
|
Inflammatory Bowel Disease
Subjects diagnosed with Crohn's Disease or Ulcerative Colitis.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Subjects will be recruited from clinics, community in and around Los Angeles Area.
Inclusion Criteria:
Men and women who meet the following criteria are eligible for inclusion in the study:
- 18 to 55 years of age
- ROME III criteria for IBS population
- Willingness to participate in this study as evidenced by a signed, written informed consent form (ICF).
- If female and of childbearing potential (i.e., not post-menopausal or documented to be surgically sterile) willingness to avoid pregnancy and practice adequate birth control (abstinence, oral contraception, intrauterine devices, implantable devices, depot contraceptives, or barrier method with spermicide) during the time of study enrollment.
- If female, negative urine pregnancy tests at Screening Visit 1, and visit 2.
- Right handed
- Ambulatory outpatient (not depending exclusively on a wheelchair for mobility)
- English is primary oral and written language.
- Diagnosed with Functional Dyspepsia using the ROME 3 Criteria
- NCCP (non cardiac chest pain) with negative cardiac workup. 11: Diagnosed with CVS
12. Diagnosed with IBD and currently not taking steroid therapy. 13. Diagnosed with vestibulodynia (a subgroup of vulvodynia)
Exclusion Criteria:
- Evidence of structural abnormality of the gastrointestinal tract. Subjects with Functional GI conditions must be without 'red flags', that may indicate gastrointestinal disease. Exclusionary GI conditions include but are not limited to: gastrointestinal surgery (exceptions: IBD group, appendectomy, benign polypectomy, cholecystectomy)also esophagitis, celiac disease, gastrointestinal malignancy or obstruction; peptic, duodenal or gastric ulcer disease.
- Clinical evidence of cardiovascular, respiratory, renal, hepatic, malignancy, hematologic, neurologic, psychiatric or any disease that the PI determines may interfere with safe participation in the study
- Use of investigational drugs, products or devices within 28 days prior to screen and through study participation.
- Subjects with current regular use of narcotics and or opioids. Use of medications/drugs that affect the central nervous system. TCA's, SSRI's or other antidepressants are allowed if on stable dose for 3 months or more.
- Pregnancy or breast feeding
- Subjects with extreme obesity (BMI > 35%)
- Subjects with metal implants, dental retainers, large tattoos (e.g. full arm or back) or claustrophobia; making MRI safety not possible.
Contacts and Locations| Contact: Jean Stains, BSN, RN | 310-206-1758 | jstains@mednet.ucla.edu |
| Contact: Nuwanthi Heendeniya, B.Sc. | 310-206-8545 | nheendeniya@mednet.ucla.edu |
| United States, California | |
| Gail and Gerald Oppenheimer Family Center for Neurobiology of Stress | Recruiting |
| Los Angeles, California, United States, 90095 | |
| Contact: Jean Stains, RN 310-206-1758 jstains@mednet.ucla.edu | |
| Contact: Nuwanthi Heendeniya, BSc 310-206-8545 nheendeniya@mednet.ucla.edu | |
| Principal Investigator: Emeran Mayer, MD | |
| Principal Investigator: | Emeran Mayer, MD | University of California, Los Angeles |
More Information
No publications provided
| Responsible Party: | Emeran Mayer, MD, Professor, Department of Medicine at the David Geffen School of Medicine, UCLA, University of California, Los Angeles |
| ClinicalTrials.gov Identifier: | NCT01517516 History of Changes |
| Other Study ID Numbers: | 11-000069, RO1 DKO48351 |
| Study First Received: | December 14, 2011 |
| Last Updated: | January 20, 2012 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
Keywords provided by University of California, Los Angeles:
|
fMRI resting state structural MRI functional MRI |
Additional relevant MeSH terms:
|
Vulvodynia Chest Pain Colitis Colitis, Ulcerative Crohn Disease Dyspepsia Irritable Bowel Syndrome Ulcer Vomiting Gastroparesis Pain Signs and Symptoms Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Colonic Diseases Intestinal Diseases Inflammatory Bowel Diseases Signs and Symptoms, Digestive Colonic Diseases, Functional Pathologic Processes Stomach Diseases Paralysis Neurologic Manifestations Vulvar Diseases Genital Diseases, Female |
ClinicalTrials.gov processed this record on May 16, 2013