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

NCT01517516 | Completed

• 2 other identifiers: 11-000069RO1 DKO48351
• Study Type: observational
• Target: 165
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

fMRI; resting state; structural MRI; functional MRI

Outcome Measures

Primary Outcomes (1)

• Resting state networks

  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.

  within 1 week of scanning visit

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Gail and Gerald Oppenheimer Family Center for Neurobiology of Stress

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome; Familial cyclic vomiting syndrome; Colitis, Ulcerative; Vulvodynia; Crohn Disease

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Colitis; Gastroenteritis; Inflammatory Bowel Diseases; Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Emeran Mayer, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Medicine at the David Geffen School of Medicine, UCLA

Study Record Dates

• First Submitted: December 14, 2011
• First Posted: January 25, 2012
• Study Start: March 1, 2011
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: January 14, 2016

Record last verified: 2016-01

Locations

US (1)