- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00677976
Use of Functional Magnetic Resonance Imaging (fMRI) to Study Brain Activation in Children With Irritable Bowel Syndrome (fMRI)
April 29, 2020 updated by: Manu Sood, Medical College of Wisconsin
Use of Functional Magnetic Resonance Imaging (fMRI) to Study Brain Activation Following Rectal Stimulation in Children With Irritable Bowel Syndrome
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
17
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Wisconsin
-
Milwaukee, Wisconsin, United States, 53226
- Medical College of Wisconsin
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 18 years (ADULT, CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Children will be selected from the Gastroenterology Clinic at Children's Hospital of Wisconsin.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
We intend to measure the degree of brain activation following rectal stimulation
Time Frame: 4 years
|
4 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Drossman DA, Li Z, Andruzzi E, Temple RD, Talley NJ, Thompson WG, Whitehead WE, Janssens J, Funch-Jensen P, Corazziari E, et al. U.S. householder survey of functional gastrointestinal disorders. Prevalence, sociodemography, and health impact. Dig Dis Sci. 1993 Sep;38(9):1569-80. doi: 10.1007/BF01303162.
- Rainville P, Duncan GH, Price DD, Carrier B, Bushnell MC. Pain affect encoded in human anterior cingulate but not somatosensory cortex. Science. 1997 Aug 15;277(5328):968-71. doi: 10.1126/science.277.5328.968.
- Berkley KJ. Sex differences in pain. Behav Brain Sci. 1997 Sep;20(3):371-80; discussion 435-513. doi: 10.1017/s0140525x97221485.
- Rasquin A, Di Lorenzo C, Forbes D, Guiraldes E, Hyams JS, Staiano A, Walker LS. Childhood functional gastrointestinal disorders: child/adolescent. Gastroenterology. 2006 Apr;130(5):1527-37. doi: 10.1053/j.gastro.2005.08.063.
- Talley NJ, Zinsmeister AR, Van Dyke C, Melton LJ 3rd. Epidemiology of colonic symptoms and the irritable bowel syndrome. Gastroenterology. 1991 Oct;101(4):927-34. doi: 10.1016/0016-5085(91)90717-y. Erratum In: Gastroenterology 1992 Feb;102(2):746.
- Hyams JS, Burke G, Davis PM, Rzepski B, Andrulonis PA. Abdominal pain and irritable bowel syndrome in adolescents: a community-based study. J Pediatr. 1996 Aug;129(2):220-6. doi: 10.1016/s0022-3476(96)70246-9.
- Hyams JS, Treem WR, Justinich CJ, Davis P, Shoup M, Burke G. Characterization of symptoms in children with recurrent abdominal pain: resemblance to irritable bowel syndrome. J Pediatr Gastroenterol Nutr. 1995 Feb;20(2):209-14. doi: 10.1097/00005176-199502000-00012.
- Walker LS, Lipani TA, Greene JW, Caines K, Stutts J, Polk DB, Caplan A, Rasquin-Weber A. Recurrent abdominal pain: symptom subtypes based on the Rome II Criteria for pediatric functional gastrointestinal disorders. J Pediatr Gastroenterol Nutr. 2004 Feb;38(2):187-91. doi: 10.1097/00005176-200402000-00016.
- Walker LS, Greene JW. The functional disability inventory: measuring a neglected dimension of child health status. J Pediatr Psychol. 1991 Feb;16(1):39-58. doi: 10.1093/jpepsy/16.1.39.
- Van Ginkel R, Voskuijl WP, Benninga MA, Taminiau JA, Boeckxstaens GE. Alterations in rectal sensitivity and motility in childhood irritable bowel syndrome. Gastroenterology. 2001 Jan;120(1):31-8. doi: 10.1053/gast.2001.20898.
- Di Lorenzo C, Youssef NN, Sigurdsson L, Scharff L, Griffiths J, Wald A. Visceral hyperalgesia in children with functional abdominal pain. J Pediatr. 2001 Dec;139(6):838-43. doi: 10.1067/mpd.2001.118883.
- Hobson AR, Aziz Q. Brain imaging and functional gastrointestinal disorders: has it helped our understanding? Gut. 2004 Aug;53(8):1198-206. doi: 10.1136/gut.2003.035642. No abstract available.
- Aziz Q, Andersson JL, Valind S, Sundin A, Hamdy S, Jones AK, Foster ER, Langstrom B, Thompson DG. Identification of human brain loci processing esophageal sensation using positron emission tomography. Gastroenterology. 1997 Jul;113(1):50-9. doi: 10.1016/s0016-5085(97)70079-9.
- Schnitzler A, Ploner M. Neurophysiology and functional neuroanatomy of pain perception. J Clin Neurophysiol. 2000 Nov;17(6):592-603. doi: 10.1097/00004691-200011000-00005.
- Willis WD, Westlund KN. Neuroanatomy of the pain system and of the pathways that modulate pain. J Clin Neurophysiol. 1997 Jan;14(1):2-31. doi: 10.1097/00004691-199701000-00002.
- Wilder-Smith CH, Schindler D, Lovblad K, Redmond SM, Nirkko A. Brain functional magnetic resonance imaging of rectal pain and activation of endogenous inhibitory mechanisms in irritable bowel syndrome patient subgroups and healthy controls. Gut. 2004 Nov;53(11):1595-601. doi: 10.1136/gut.2003.028514.
- Sidhu H, Kern M, Shaker R. Absence of increasing cortical fMRI activity volume in response to increasing visceral stimulation in IBS patients. Am J Physiol Gastrointest Liver Physiol. 2004 Aug;287(2):G425-35. doi: 10.1152/ajpgi.00490.2003.
- Lawal A, Kern M, Sanjeevi A, Hofmann C, Shaker R. Cingulate cortex: a closer look at its gut-related functional topography. Am J Physiol Gastrointest Liver Physiol. 2005 Oct;289(4):G722-30. doi: 10.1152/ajpgi.00016.2005.
- Drossman DA, Ringel Y, Vogt BA, Leserman J, Lin W, Smith JK, Whitehead W. Alterations of brain activity associated with resolution of emotional distress and pain in a case of severe irritable bowel syndrome. Gastroenterology. 2003 Mar;124(3):754-61. doi: 10.1053/gast.2003.50103.
- Derbyshire SW. A systematic review of neuroimaging data during visceral stimulation. Am J Gastroenterol. 2003 Jan;98(1):12-20. doi: 10.1111/j.1572-0241.2003.07168.x.
- Lawal A, Kern M, Sidhu H, Hofmann C, Shaker R. Novel evidence for hypersensitivity of visceral sensory neural circuitry in irritable bowel syndrome patients. Gastroenterology. 2006 Jan;130(1):26-33. doi: 10.1053/j.gastro.2005.10.020.
- Verne GN, Himes NC, Robinson ME, Gopinath KS, Briggs RW, Crosson B, Price DD. Central representation of visceral and cutaneous hypersensitivity in the irritable bowel syndrome. Pain. 2003 May;103(1-2):99-110. doi: 10.1016/s0304-3959(02)00416-5.
- Whitehead WE, Palsson OS. Is rectal pain sensitivity a biological marker for irritable bowel syndrome: psychological influences on pain perception. Gastroenterology. 1998 Nov;115(5):1263-71. doi: 10.1016/s0016-5085(98)70099-x.
- Gregory LJ, Yaguez L, Williams SC, Altmann C, Coen SJ, Ng V, Brammer MJ, Thompson DG, Aziz Q. Cognitive modulation of the cerebral processing of human oesophageal sensation using functional magnetic resonance imaging. Gut. 2003 Dec;52(12):1671-7. doi: 10.1136/gut.52.12.1671.
- Devinsky O, Morrell MJ, Vogt BA. Contributions of anterior cingulate cortex to behaviour. Brain. 1995 Feb;118 ( Pt 1):279-306. doi: 10.1093/brain/118.1.279.
- Paus T. Primate anterior cingulate cortex: where motor control, drive and cognition interface. Nat Rev Neurosci. 2001 Jun;2(6):417-24. doi: 10.1038/35077500.
- Andresen V, Bach DR, Poellinger A, Tsrouya C, Stroh A, Foerschler A, Georgiewa P, Zimmer C, Monnikes H. Brain activation responses to subliminal or supraliminal rectal stimuli and to auditory stimuli in irritable bowel syndrome. Neurogastroenterol Motil. 2005 Dec;17(6):827-37. doi: 10.1111/j.1365-2982.2005.00720.x.
- Lorenz J, Minoshima S, Casey KL. Keeping pain out of mind: the role of the dorsolateral prefrontal cortex in pain modulation. Brain. 2003 May;126(Pt 5):1079-91. doi: 10.1093/brain/awg102.
- Vogt BA, Wiley RG, Jensen EL. Localization of Mu and delta opioid receptors to anterior cingulate afferents and projection neurons and input/output model of Mu regulation. Exp Neurol. 1995 Oct;135(2):83-92. doi: 10.1006/exnr.1995.1069.
- Kern MK, Jaradeh S, Arndorfer RC, Jesmanowicz A, Hyde J, Shaker R. Gender differences in cortical representation of rectal distension in healthy humans. Am J Physiol Gastrointest Liver Physiol. 2001 Dec;281(6):G1512-23. doi: 10.1152/ajpgi.2001.281.6.G1512.
- Berman S, Munakata J, Naliboff BD, Chang L, Mandelkern M, Silverman D, Kovalik E, Mayer EA. Gender differences in regional brain response to visceral pressure in IBS patients. Eur J Pain. 2000;4(2):157-72. doi: 10.1053/eujp.2000.0167.
- Naliboff BD, Berman S, Chang L, Derbyshire SW, Suyenobu B, Vogt BA, Mandelkern M, Mayer EA. Sex-related differences in IBS patients: central processing of visceral stimuli. Gastroenterology. 2003 Jun;124(7):1738-47. doi: 10.1016/s0016-5085(03)00400-1.
- Houghton LA, Lea R, Jackson N, Whorwell PJ. The menstrual cycle affects rectal sensitivity in patients with irritable bowel syndrome but not healthy volunteers. Gut. 2002 Apr;50(4):471-4. doi: 10.1136/gut.50.4.471.
- Houghton LA, Jackson NA, Whorwell PJ, Morris J. Do male sex hormones protect from irritable bowel syndrome? Am J Gastroenterol. 2000 Sep;95(9):2296-300. doi: 10.1111/j.1572-0241.2000.02314.x.
- Chang L, Heitkemper MM. Gender differences in irritable bowel syndrome. Gastroenterology. 2002 Nov;123(5):1686-701. doi: 10.1053/gast.2002.36603.
- Petersen S, Bergstrom E, Brulin C. High prevalence of tiredness and pain in young schoolchildren. Scand J Public Health. 2003;31(5):367-74. doi: 10.1080/14034940210165064.
- Groholt EK, Stigum H, Nordhagen R, Kohler L. Recurrent pain in children, socio-economic factors and accumulation in families. Eur J Epidemiol. 2003;18(10):965-75. doi: 10.1023/a:1025889912964.
- Perquin CW, Hunfeld JA, Hazebroek-Kampschreur AA, van Suijlekom-Smit LW, Passchier J, Koes BW, van der Wouden JC. The natural course of chronic benign pain in childhood and adolescence: a two-year population-based follow-up study. Eur J Pain. 2003;7(6):551-9. doi: 10.1016/S1090-3801(03)00060-0.
- Chitkara DK, Rawat DJ, Talley NJ. The epidemiology of childhood recurrent abdominal pain in Western countries: a systematic review. Am J Gastroenterol. 2005 Aug;100(8):1868-75. doi: 10.1111/j.1572-0241.2005.41893.x.
- Hunfeld JA, Perquin CW, Hazebroek-Kampschreur AA, Passchier J, van Suijlekom-Smit LW, van der Wouden JC. Physically unexplained chronic pain and its impact on children and their families: the mother's perception. Psychol Psychother. 2002 Sep;75(Pt 3):251-60. doi: 10.1348/147608302320365172.
- Caviness VS Jr, Kennedy DN, Richelme C, Rademacher J, Filipek PA. The human brain age 7-11 years: a volumetric analysis based on magnetic resonance images. Cereb Cortex. 1996 Sep-Oct;6(5):726-36. doi: 10.1093/cercor/6.5.726.
- Reiss AL, Abrams MT, Singer HS, Ross JL, Denckla MB. Brain development, gender and IQ in children. A volumetric imaging study. Brain. 1996 Oct;119 ( Pt 5):1763-74. doi: 10.1093/brain/119.5.1763.
- Giedd JN, Snell JW, Lange N, Rajapakse JC, Casey BJ, Kozuch PL, Vaituzis AC, Vauss YC, Hamburger SD, Kaysen D, Rapoport JL. Quantitative magnetic resonance imaging of human brain development: ages 4-18. Cereb Cortex. 1996 Jul-Aug;6(4):551-60. doi: 10.1093/cercor/6.4.551.
- Burgund ED, Kang HC, Kelly JE, Buckner RL, Snyder AZ, Petersen SE, Schlaggar BL. The feasibility of a common stereotactic space for children and adults in fMRI studies of development. Neuroimage. 2002 Sep;17(1):184-200. doi: 10.1006/nimg.2002.1174.
- Kang HC, Burgund ED, Lugar HM, Petersen SE, Schlaggar BL. Comparison of functional activation foci in children and adults using a common stereotactic space. Neuroimage. 2003 May;19(1):16-28. doi: 10.1016/s1053-8119(03)00038-7.
- Duke PM, Litt IF, Gross RT. Adolescents' self-assessment of sexual maturation. Pediatrics. 1980 Dec;66(6):918-20.
- Liu X, Li SJ, Shaker R, Silverman A, Kern M, Ward DB, Li W, Xu Z, Chelimsky G, Sood MR. Reduced Functional Connectivity Between the Hypothalamus and High-order Cortical Regions in Adolescent Patients With Irritable Bowel Syndrome. J Pediatr Gastroenterol Nutr. 2017 Nov;65(5):516-519. doi: 10.1097/MPG.0000000000001611.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Primary Completion (ACTUAL)
June 1, 2013
Study Completion (ACTUAL)
June 1, 2013
Study Registration Dates
First Submitted
May 12, 2008
First Submitted That Met QC Criteria
May 12, 2008
First Posted (ESTIMATE)
May 15, 2008
Study Record Updates
Last Update Posted (ACTUAL)
April 30, 2020
Last Update Submitted That Met QC Criteria
April 29, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHW 06/163
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Irritable Bowel Syndrome
-
ProgenaBiomeWithdrawnIrritable Bowel Syndrome | Irritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome With Constipation | Irritable Bowel Syndrome Characterized by Constipation | Irritable Bowel Syndrome Mixed | Irritable Bowel Syndrome Without Diarrhea | Irritable Bowel | Irritable Bowel Syndrome Aggravated and other conditionsUnited States
-
Universidad Autonoma de Nuevo LeonUniversidad Autonoma de Nuevo LeonEnrolling by invitationIrritable Bowel Syndrome | Irritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome With Constipation | Irritable Bowel Syndrome MixedMexico
-
Istanbul Medipol University HospitalTepecik Training and Research Hospital; Bozyaka Training and Research Hospital and other collaboratorsRecruitingIrritable Bowel Syndrome | Irritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome With Constipation | Irritable Bowel Syndrome MixedTurkey
-
Research and Practical Clinical Center for Diagnostics...I.M. Sechenov First Moscow State Medical UniversityEnrolling by invitationIrritable Bowel Syndrome | Irritable Bowel Syndrome - Constipation | Irritable Bowel Syndrome - Diarrhoea | Irritable Bowel Syndrome - MixedRussian Federation
-
ClasadoCR2O B.V.CompletedIrritable Bowel Syndrome | Irritable Bowel Syndrome - Constipation | Irritable Bowel Syndrome - Diarrhoea | Irritable Bowel Syndrome - MixedBelgium, Netherlands, United Kingdom
-
Md Mehedi ShahriarNot yet recruitingChronic Idiopathic Constipation | Chronic Constipation | CIC | Constipation Predominant Irritable Bowel Syndrome | Irritable Bowel Syndrome (IBS-C)Bangladesh
-
Federal Stare Budgetary Scientific Institution,...I.M. Sechenov First Moscow State Medical University; RML INVEST, Torkhovsky...CompletedIrritable Bowel Syndrome | Irritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome With Constipation | Irritable Bowel Syndrome MixedRussian Federation
-
Dr Anthony HobsonCompletedIrritable Bowel Syndrome (IBS) | Irritable Bowel Syndrome With Diarrhea (IBS-D)United Kingdom
-
Beijing Tiantan HospitalHebei Medical University Third Hospital; Hengshui People's HospitalRecruitingIrritable Bowel Syndrome (IBS)China
-
Iuliu Hatieganu University of Medicine and PharmacyNot yet recruitingIrritable Bowel Syndrome (IBS)Romania