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

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 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.

Condition or disease
Irritable Bowel Syndrome Cyclical Vomiting Syndrome Ulcerative Colitis Vulvodynia Crohn's Disease

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 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.

Study Type : Observational
Actual Enrollment : 165 participants
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 Such as IBS or Vulvodynia, IBD and Healthy Controls
Study Start Date : March 2011
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
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:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01517516

United States, California
Gail and Gerald Oppenheimer Family Center for Neurobiology of Stress
Los Angeles, California, United States, 90095
Sponsors and Collaborators
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

Responsible Party: Emeran Mayer, MD, Professor, Department of Medicine at the David Geffen School of Medicine, UCLA, University of California, Los Angeles Identifier: NCT01517516     History of Changes
Other Study ID Numbers: 11-000069
RO1 DKO48351 ( Other Grant/Funding Number: NIDDK )
First Posted: January 25, 2012    Key Record Dates
Last Update Posted: January 14, 2016
Last Verified: January 2016

Keywords provided by Emeran Mayer, MD, University of California, Los Angeles:
resting state
structural MRI
functional MRI

Additional relevant MeSH terms:
Crohn Disease
Colitis, Ulcerative
Irritable Bowel Syndrome
Pathologic Processes
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colonic Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Vulvar Diseases
Genital Diseases, Female