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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01517516
Recruitment Status : Completed
First Posted : January 25, 2012
Last Update Posted : January 14, 2016
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Emeran Mayer, MD, University of California, Los Angeles

December 14, 2011
January 25, 2012
January 14, 2016
March 2011
July 2015   (Final data collection date for primary outcome measure)
Resting state networks [ Time Frame: within 1 week of scanning visit ]
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 Archive Site
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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 Such as IBS or Vulvodynia, 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 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.

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 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.

We have added a single stool sample for microbiota analysis and a food frequency questionnaire in the healthy control and IBS populations.

Observational Model: Case Control
Time Perspective: Cross-Sectional
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Probability Sample
Subjects will be recruited from clinics, community in and around Los Angeles Area.
  • Irritable Bowel Syndrome
  • Cyclical Vomiting Syndrome
  • Ulcerative Colitis
  • Vulvodynia
  • Crohn's Disease
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  • Functional Pain Conditions and Inflammatory bowel disease
    Cyclical Vomiting Syndrome, Irritable Bowel Syndrome, Inflammatory Bowel disease (Ulcerative colitis and Crohns)and Vulvodynia (vestibulodynia)
  • Inflammatory Bowel Disease
    Subjects diagnosed with Crohn's Disease or Ulcerative Colitis.
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 2015
July 2015   (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 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 CVS
  10. Diagnosed with IBD and currently not taking steroid therapy.
  11. Diagnosed with vestibulodynia (a subgroup of vulvodynia)
  12. Pre and peri menopausal only, post menopausal excluded.

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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
RO1 DKO48351 ( Other Grant/Funding Number: NIDDK )
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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 2016