Use of Functional Magnetic Resonance Imaging (fMRI) to Study Brain Activation in Children With Irritable Bowel Syndrome

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Manu Sood, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT00677976
First received: May 12, 2008
Last updated: October 1, 2014
Last verified: October 2014
  Purpose

The purpose of the study is to map regions of brain activation following rectal stimulation in children with irritable bowel syndrome (IBS) and healthy controls.


Condition
Irritable Bowel Syndrome

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Use of Functional Magnetic Resonance Imaging (fMRI) to Study Brain Activation Following Rectal Stimulation in Children With Irritable Bowel Syndrome

Resource links provided by NLM:


Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:
  • We intend to measure the degree of brain activation following rectal stimulation [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: June 2007
Estimated Study Completion Date: December 2015
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
IBS
Children between the ages of 10 and 18 who meet Rome III criteria for IBS as determined by a pediatric gastroenterologist.
Control
Healthy children between the ages of 10 and 18.

Detailed Description:

Our first aim is to compare the brain areas activated rectal stimulation in boys and girls with IBS and healthy children. Our second aim is to compare the anatomic regions of the brain activated during rectal stimulation in pre and post-pubertal male and female subjects between 10-18 yrs of age.

  Eligibility

Ages Eligible for Study:   10 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Children will be selected from the Gastroenterology Clinic at Children's Hospital of Wisconsin.

Criteria

Inclusion Criteria:

  • Children aged 10 years to 18 years who provide written assent and whose parents provide written permission for participation
  • English-speaking
  • Subjects in the IBS group will meet Rome III criteria for IBS as determined by a pediatric gastroenterologist.

Exclusion Criteria:

  • Other pain-related diseases, functional gastrointestinal disorders, or somatization disorder
  • Mental retardation or pervasive developmental disorder or epilepsy
  • Psychosis
  • Genetic or chromosomal disorders
  • Currently receiving psychoactive drug treatment
  • Patients with pacemakers, metal clips used in previous surgery or other device which are not compatible with MRI scanning
  • Inability to lie still in the scanner
  • Claustrophobia (Inability to lie still in the scanner)
  • Pregnancy
  • Subjects who admit to substance abuse during screening
  • Orthodontic braces
  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: NCT00677976

Locations
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
Investigators
Principal Investigator: Manu Sood, MD Medical College of Wisconsin
  More Information

Publications:
Berkley KJ. Sex differences in pain. Behav Brain Sci. 1997;20(3):371-80

Responsible Party: Manu Sood, Chief, Associate Professor, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT00677976     History of Changes
Other Study ID Numbers: CHW 06/163
Study First Received: May 12, 2008
Last Updated: October 1, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Medical College of Wisconsin:
fMRI
IBS
Brain Activation

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Syndrome
Colonic Diseases
Colonic Diseases, Functional
Digestive System Diseases
Disease
Gastrointestinal Diseases
Intestinal Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 21, 2014