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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of California, Los Angeles
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: June 2, 2014
Last verified: May 2014
  Purpose

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

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 240
Study Start Date: March 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01517516

Contacts
Contact: Jean Stains, BSN, RN 310-206-1758 jstains@mednet.ucla.edu
Contact: Nuwanthi Heendeniya, B.Sc. 310-206-8545 nheendeniya@mednet.ucla.edu

Locations
United States, California
Gail and Gerald Oppenheimer Family Center for Neurobiology of Stress Recruiting
Los Angeles, California, United States, 90095
Contact: Jean Stains, RN    310-206-1758    jstains@mednet.ucla.edu   
Contact: Nuwanthi Heendeniya, BSc    310-206-8545    nheendeniya@mednet.ucla.edu   
Principal Investigator: Emeran Mayer, MD         
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Emeran Mayer, MD University of California, Los Angeles
  More Information

No publications provided

Responsible Party: Emeran Mayer, MD, Professor, Department of Medicine at the David Geffen School of Medicine, UCLA, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01517516     History of Changes
Other Study ID Numbers: 11-000069, RO1 DKO48351
Study First Received: December 14, 2011
Last Updated: June 2, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of California, Los Angeles:
fMRI
resting state
structural MRI
functional MRI

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

ClinicalTrials.gov processed this record on October 21, 2014