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

This study is currently recruiting participants.

Verified January 2013 by Medical College of Wisconsin

Sponsor:

Information provided by (Responsible Party):

Manu Sood, Medical College of Wisconsin

ClinicalTrials.gov Identifier:

NCT00677976

First received: May 12, 2008

Last updated: January 7, 2013

Last verified: January 2013

History of Changes

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:

MedlinePlus related topics: MRI Scans

U.S. FDA Resources

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 2013
Estimated Primary Completion Date:	December 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00677976

Contacts

Contact: Manu Sood, MD

414-266-3690

msood@mcw.edu

Locations

United States, Wisconsin
Medical College of Wisconsin	Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Manu Sood, MD 414-266-3690 msood@mcw.edu
Sub-Investigator: Reza Shaker, MD
Sub-Investigator: Alan Silverman, PhD
Sub-Investigator: Adrian Miranda, MD

Sponsors and Collaborators

Medical College of Wisconsin

Investigators

Principal Investigator:

Manu Sood, MD

Medical College of Wisconsin

More Information

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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:	January 7, 2013
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
Colonic Diseases, Functional
Colonic Diseases

Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on June 18, 2013

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