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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by University of California, Los Angeles.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Emeran Mayer, MD, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01517516
First received: December 14, 2011
Last updated: January 20, 2012
Last verified: January 2012

December 14, 2011
January 20, 2012
March 2011
August 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01517516 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Multi Modal Imaging: An MRI Study to Investigate Differences in the Structure and the Function of the Brain at Rest.
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

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Probability Sample

Subjects will be recruited from clinics, community in and around Los Angeles Area.

  • Irritable Bowel Syndrome
  • Non Cardiac Chest Pain
  • Cyclical Vomiting Syndrome
  • Functional Dyspepsia
  • Gastroparesis
  • Ulcerative Colitis
  • Vulvodynia
  • Crohn's Disease
Not Provided
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
240
August 2013
August 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

Men and women who meet the following criteria are eligible for inclusion in the study:

  1. 18 to 55 years of age
  2. ROME III criteria for IBS population
  3. Willingness to participate in this study as evidenced by a signed, written informed consent form (ICF).
  4. 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.
  5. If female, negative urine pregnancy tests at Screening Visit 1, and visit 2.
  6. Right handed
  7. Ambulatory outpatient (not depending exclusively on a wheelchair for mobility)
  8. English is primary oral and written language.
  9. Diagnosed with Functional Dyspepsia using the ROME 3 Criteria
  10. 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:

  1. 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.
  2. 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
  3. Use of investigational drugs, products or devices within 28 days prior to screen and through study participation.
  4. 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.
  5. Pregnancy or breast feeding
  6. Subjects with extreme obesity (BMI > 35%)
  7. Subjects with metal implants, dental retainers, large tattoos (e.g. full arm or back) or claustrophobia; making MRI safety not possible.
Both
18 Years to 55 Years
No
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
 
NCT01517516
11-000069, RO1 DKO48351
No
Emeran Mayer, MD, University of California, Los Angeles
University of California, Los Angeles
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Emeran Mayer, MD University of California, Los Angeles
University of California, Los Angeles
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP