Multi Modal Imaging: An MRI Study to Investigate Differences in the Structure and the Function of the Brain at Rest.

Completed

Conditions studied: Irritable Bowel Syndrome, Cyclical Vomiting Syndrome, Ulcerative Colitis, Vulvodynia, Crohn's Disease

In brief

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.

Key facts

Study ID

NCT01517516

Run by

University of California, Los Angeles

People needed

165

Starts

2011-03-01

Expected to finish

2015-07-01

Last updated by the study team

2016-01-14

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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 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 CVS
• Diagnosed with IBD and currently not taking steroid therapy.
• Diagnosed with vestibulodynia (a subgroup of vulvodynia)
• Pre and peri menopausal only, post menopausal excluded.

You may not qualify if…

• 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.

Where it is running

• Gail and Gerald Oppenheimer Family Center for Neurobiology of Stress — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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