Status:
COMPLETED
Multi Modal Imaging: An MRI Study to Investigate Differences in the Structure and the Function of the Brain at Rest.
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Irritable Bowel Syndrome
Cyclical Vomiting Syndrome
Eligibility:
All Genders
18-55 years
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 differen...
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT01517516
Start Date
March 1 2011
End Date
July 1 2015
Last Update
January 14 2016
Active Locations (1)
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1
Gail and Gerald Oppenheimer Family Center for Neurobiology of Stress
Los Angeles, California, United States, 90095