Crohn's DiseaseDouleur IRMfNCT02874495
Anticipation Effect on Painful Phenomenons Linked to Rectal Distension for Patients With a Crohn's Disease in Remission
An observational study of Crohn's Disease, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Crohn's disease goes along with an alteration of the quality of life, even in remission and has a negative impact on stress management linked to the pain and the health. Conversely, stress and psychological variables play a significant role in the pathogenesis of this disease. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Psychological tests, Magnetic Resonance Imaging and Heart Rate Variability
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 44 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2012to Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients with Crohn's disease
Who may be able to join
- For patients :
- Patients over 18 years and less than 60 years.
- Right-handed.
- Diagnosis of Crohn's disease established on clinical biological, endoscopic and anatomopathological criteria.
- Ideal localization and/or diarrhea of Crohn's Disease, with an absence of rectal or anoperineal ravages past or presents in order to not do distension on rectal/ and anoperineal lesions.
- Crohn's disease treatment authorize : 5-aminosalicylates since at least 4 weeks with a stable dose since at least 2 weeks ; immunosuppressive drugs since at least 12 weeks with a stable dose since at least 4 weeks ; anti-TNF since at least 3 months with a stable dose since at least 1 month ; absence of corticosteroid treatment since at least 15 days.
Show all 20Show fewer
- Clinical remission : Crohn's Disease Activity Index (CDAI) < 150 (Best 1976) and biological : normal CRP and faecal calprotectin < 100 g/g.
- Patient able to understand and follow necessary commissions for the conduct of the clinical trial, and that have given his free written consent for this study.
- Registered to a French social security.
- The person won't be allow to participate simultaneously to another study and there won't be an exclusion period to participation to a clinical or therapeutic trial at the end of this study.
- For healthy volunteers
- Patients over 18 years and less than 60 years.
- Right-handed.
- Paired with patients for sex and age.
- Absence of digestive surgical or medical history except appendectomy, hysterectomy, cholecystectomy, inguinal hernia cure and/or femoral.
- Absence of digestive symptomatology searched while a standardized interrogation.
- Clinical digestive exam normal.
- The person won't be allow to participate simultaneously to another study and there won't be an exclusion period to. participation to a clinical or therapeutic trial at the end of this study.
- Registered to a French social security.
- Registered to the national file of persons participating to biomedicals searches without direct individual profit.
Who cannot join
- Subjet under 18 years and more than 60 years.
- Counter-argument for MRI : presence of intra-corporeal ferro-magnetic particles, claustrophobia.
- Existence of a severe condition on general level (cardiac, respiratory, hematological, renal, hepatic, cancerous).
- Existence of an organic digestive affection (gastritis, gallstones, duodenal ulcer, megacolon, inflammatory colitis).
- Existence or history malignant gastrointestinal condition.
- History of abdominal digestive surgery except appendectomy, hysterectomy, cure of inguinal hernia)
Show all 13Show fewer
- Recto-anal or périneal active pathology (haemorrhoid , anal fissure …).
- Presence of arectal fecal impaction.
- Patient included in an other clinical or therapeutic trial.
- Patient treated by a drug sensitive to modify sensitivity and/or digestive motor function.
- Patient regularly receiving psychotropic drugs (anxiolytics, sedatives, antidepressants, neuroleptics).
- Patient with a pathology that could modify visceral sensitivity like diabetes or neurodegenerative diseases.
- Persons concerned by articles L1121-5 to L1121-8 of CSP.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
UniversityHospitalGrenoble
La Tronche, 38700
Bruno Bonaz, Professor, 04.76.76.55.97, BBonaz@chu-grenoble.fr
Amandine Rubio, Medical doctor, 04.76.76.59.11, arubio@chu-grenoble.fr
About this study
Official title: Anticipation Effect on Painful Phenomenons Linked to Rectal Distension for Patients With a Crohn's Disease in Remission: Functional MRI Study
Crohn's disease goes along with an alteration of the quality of life, even in remission and has a negative impact on stress management linked to the pain and the health. Conversely, stress and psychological variables play a significant role in the pathogenesis of this disease. These interrelations reflects the link between the brain and the digestive tract, called brain-gut axis. The autonomic nervous system (ANS) is the neurological interface, relaying in a bidirectional way, informations between the digestive tract and the central nervous system (CNS).
Visceral information can thus modulate the functionnement of CNS's areas involved in pain management but also in the management of emotional and cognitive behaviours. Yet, numerous work demonstrate the existence of a dysfunction of the ANS during Crohn's disease, with a dysautonomia of the sympatho-vagal balance.
Read more
Human brain respond by advance before and during the application of a painful stimulus that enable the organism to regulate its nociceptive system in order to handle the aversive stimulus incoming, via the activation of brin areas managing the pain, or the raise of pain awareness.
The uncertain and not predictable nature of a painful crisis and/or an inflammatory relapse in a chronic disease like Crohn's disease can be the origin of an anticipating apprehension and anxiety, that could influence visceral perception (increasing it). Nevertheless, only few studies exists about the differential role of certain or uncertain anticipation of the pain, despite the fact that they are associated to different emotional, cognitive and behavioral responses, and the effect of anticipation on painful visceral perception, have not yet been studied for parents in remission of Crohn's disease.
The main goal is to search during certain and uncertain visceral anticipation, induced by distension of an intra-rectal balloon for persons suffering from Crohn's disease in remission, compared to control subjects, with an MRI functional study
- Conditions
- Crohn's Disease
- Being tested
- Psychological tests, Magnetic Resonance Imaging, Heart Rate Variability
- Keywords
- Crohn's disease, Rectal Distension, Remission, Anticipation, Painful
- Medical subject headings
- Crohn Disease, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological testsBehavioural
Related to affective and cognitive dimensions of pain.
Magnetic Resonance ImagingDevice
Also called MRI
With a certain or uncertain anticipation phase of distension (warning light) followed or not by a rectal distension at the pain threshold previously determined, and then a retrospective quotation of pain during distension and the fear of pain induced by anticipation. Structural MRI and rest of functional connectivity measure MRI.
With measure of heart rate variability.
Heart Rate VariabilityBehavioural
Also called HRV
During MRI session, from the electrocardiographic signal. (measure of variations on R-R interval in milliseconds ms).
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | 22 persons. Receives: Behavioral: Psychological tests; Device: Magnetic Resonance Imaging; Behavioral: Heart Rate Variability | |
| Patients with Crohn's disease | 22 patients. Receives: Behavioral: Psychological tests; Device: Magnetic Resonance Imaging; Behavioral: Heart Rate Variability |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnetic Resonance Imaging
Activation of cortical cerebral structures involved in visceral pain and communication paths between them With a certain or uncertain anticipation phase of distension (warning light) followed or not by a rectal distension at the pain threshold previously determined, and then a retrospective quotation of pain during distension and the fear of pain induced by anticipation. Structural MRI and rest of functional connectivity measure MRI.
With measure of heart rate variability.
Measured: 30 minutes
Heart Rate Variability
During MRI session, from the electrocardiographic signal. (measure of variations on R-R interval in milliseconds ms).
Measured: 30 minutes
Psychological tests
Related to affective and cognitive dimensions of pain :
Questionnaire of personality inventory NEO-FFI (Bouvard, 2005)
Measured: 45 minutes
Psychological tests
Related to affective and cognitive dimensions of pain :
Questionnaire of depressive symptomatology CES-D (Center for Epidemiologic Studies-Depression Scale; Radloff, 1977)
Measured: 45 minutes
Psychological tests
Related to affective and cognitive dimensions of pain :
Anxiety inventory (STAI-Y of Spielberger)
Measured: 45 minutes
Psychological tests
Related to affective and cognitive dimensions of pain :
Pain Catastrophizing Scale of Sullivan 1995
Measured: 45 minutes
Psychological tests
Related to affective and cognitive dimensions of pain :
Pain Anxiety Symptoms Scale of Cracken 1992
Measured: 45 minutes
Psychological tests
Related to affective and cognitive dimensions of pain :
Fear of Pain Questionnaire of McNeil andRainwater ; 1998
Measured: 45 minutes
Psychological tests
Related to affective and cognitive dimensions of pain :
Visceral Sensitivity Index of Labus; 2004
Measured: 45 minutes
Psychological tests
Related to affective and cognitive dimensions of pain :
Questionnaire of Mindfulness, Walach 2006
Measured: 45 minutes
Psychological tests
Related to affective and cognitive dimensions of pain :
Questionnaire for uncertainty intolerance (Freeston 1994)
Measured: 45 minutes
Psychological tests
Related to affective and cognitive dimensions of pain :
The Illness Attitude Scales, Dammen 1999
Measured: 45 minutes
Psychological tests
Related to affective and cognitive dimensions of pain :
Childhood Trauma Questionnaire of Bernstein 2003
Measured: 45 minutes
Psychological tests
Related to affective and cognitive dimensions of pain :
Ways of Coping Checklist Revised, adapted in French by Cousson 1996
Measured: 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2016 (estimated)
- Study startJan 2012
- Primary completionApr 2017 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (86)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruno Bonaz, Professor, Principal investigator, Grenoble Hospital University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02874495
- Sponsor's protocol ID
- 38RC11.220
- Acronym
- Douleur IRMf
- Status last verified
- Aug 2016
- First submitted
- 25 Jul 2016
- Last updated
- 22 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Achard S, Salvador R, Whitcher B, Suckling J, Bullmore E. A resilient, low-frequency, small-world human brain functional network with highly connected association cortical hubs. J Neurosci. 2006 Jan 4;26(1):63-72. doi: 10.1523/JNEUROSCI.3874-05.2006.
PubMed 16399673Al-Chaer ED, Lawand NB, Westlund KN, Willis WD. Visceral nociceptive input into the ventral posterolateral nucleus of the thalamus: a new function for the dorsal column pathway. J Neurophysiol. 1996 Oct;76(4):2661-74. doi: 10.1152/jn.1996.76.4.2661.
PubMed 8899636Baciu MV, Bonaz BL, Papillon E, Bost RA, Le Bas JF, Fournet J, Segebarth CM. Central processing of rectal pain: a functional MR imaging study. AJNR Am J Neuroradiol. 1999 Nov-Dec;20(10):1920-4.
PubMed 10588119Baert F, Moortgat L, Van Assche G, Caenepeel P, Vergauwe P, De Vos M, Stokkers P, Hommes D, Rutgeerts P, Vermeire S, D'Haens G; Belgian Inflammatory Bowel Disease Research Group; North-Holland Gut Club. Mucosal healing predicts sustained clinical remission in patients with early-stage Crohn's disease. Gastroenterology. 2010 Feb;138(2):463-8; quiz e10-1. doi: 10.1053/j.gastro.2009.09.056. Epub 2009 Oct 8.
PubMed 19818785Benarroch EE. The central autonomic network: functional organization, dysfunction, and perspective. Mayo Clin Proc. 1993 Oct;68(10):988-1001. doi: 10.1016/s0025-6196(12)62272-1.
PubMed 8412366Berman SM, Naliboff BD, Suyenobu B, Labus JS, Stains J, Ohning G, Kilpatrick L, Bueller JA, Ruby K, Jarcho J, Mayer EA. Reduced brainstem inhibition during anticipated pelvic visceral pain correlates with enhanced brain response to the visceral stimulus in women with irritable bowel syndrome. J Neurosci. 2008 Jan 9;28(2):349-59. doi: 10.1523/JNEUROSCI.2500-07.2008.
PubMed 18184777Bernstein DP, Stein JA, Newcomb MD, Walker E, Pogge D, Ahluvalia T, Stokes J, Handelsman L, Medrano M, Desmond D, Zule W. Development and validation of a brief screening version of the Childhood Trauma Questionnaire. Child Abuse Negl. 2003 Feb;27(2):169-90. doi: 10.1016/s0145-2134(02)00541-0.
PubMed 12615092Best WR, Becktel JM, Singleton JW, Kern F Jr. Development of a Crohn's disease activity index. National Cooperative Crohn's Disease Study. Gastroenterology. 1976 Mar;70(3):439-44.
PubMed 1248701Biswal BB, Mennes M, Zuo XN, Gohel S, Kelly C, Smith SM, Beckmann CF, Adelstein JS, Buckner RL, Colcombe S, Dogonowski AM, Ernst M, Fair D, Hampson M, Hoptman MJ, Hyde JS, Kiviniemi VJ, Kotter R, Li SJ, Lin CP, Lowe MJ, Mackay C, Madden DJ, Madsen KH, Margulies DS, Mayberg HS, McMahon K, Monk CS, Mostofsky SH, Nagel BJ, Pekar JJ, Peltier SJ, Petersen SE, Riedl V, Rombouts SA, Rypma B, Schlaggar BL, Schmidt S, Seidler RD, Siegle GJ, Sorg C, Teng GJ, Veijola J, Villringer A, Walter M, Wang L, Weng XC, Whitfield-Gabrieli S, Williamson P, Windischberger C, Zang YF, Zhang HY, Castellanos FX, Milham MP. Toward discovery science of human brain function. Proc Natl Acad Sci U S A. 2010 Mar 9;107(10):4734-9. doi: 10.1073/pnas.0911855107. Epub 2010 Feb 22.
PubMed 20176931Bitton A, Dobkin PL, Edwardes MD, Sewitch MJ, Meddings JB, Rawal S, Cohen A, Vermeire S, Dufresne L, Franchimont D, Wild GE. Predicting relapse in Crohn's disease: a biopsychosocial model. Gut. 2008 Oct;57(10):1386-92. doi: 10.1136/gut.2007.134817. Epub 2008 Apr 7.
PubMed 18390994Blankstein U, Chen J, Diamant NE, Davis KD. Altered brain structure in irritable bowel syndrome: potential contributions of pre-existing and disease-driven factors. Gastroenterology. 2010 May;138(5):1783-9. doi: 10.1053/j.gastro.2009.12.043. Epub 2010 Jan 4.
PubMed 20045701Bonaz B, Plourde V, Tache Y. Abdominal surgery induces Fos immunoreactivity in the rat brain. J Comp Neurol. 1994 Nov 8;349(2):212-22. doi: 10.1002/cne.903490205.
PubMed 7860779Bonaz B, Tache Y. Induction of Fos immunoreactivity in the rat brain after cold-restraint induced gastric lesions and fecal excretion. Brain Res. 1994 Jul 25;652(1):56-64. doi: 10.1016/0006-8993(94)90316-6.
PubMed 7953723Bonaz B, Tache Y. Water-avoidance stress-induced c-fos expression in the rat brain and stimulation of fecal output: role of corticotropin-releasing factor. Brain Res. 1994 Mar 28;641(1):21-8. doi: 10.1016/0006-8993(94)91810-4.
PubMed 8019847Bonaz B, Riviere PJ, Sinniger V, Pascaud X, Junien JL, Fournet J, Feuerstein C. Fedotozine, a kappa-opioid agonist, prevents spinal and supra-spinal Fos expression induced by a noxious visceral stimulus in the rat. Neurogastroenterol Motil. 2000 Apr;12(2):135-47. doi: 10.1046/j.1365-2982.2000.00188.x.
PubMed 10771495
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anticipation Effect on Painful Phenomenons Linked to Rectal Distension for Patients With a Crohn's Disease in Remission: Functional MRI Study
- ClinicalTrials.gov ID
- NCT02874495
- Acronym / sponsor ID
- Douleur IRMf / 38RC11.220
- Conditions
- Crohn's Disease
- Keywords
- Crohn's disease, Rectal Distension, Remission, Anticipation, Painful
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 22 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Crohn's disease goes along with an alteration of the quality of life, even in remission and has a negative impact on stress management linked to the pain and the health. Conversely, stress and psychological variables play a significant role in the pathogenesis of this disease. These interrelations reflects the link between the brain and the digestive tract, called brain-gut axis. The autonomic nervous system (ANS) is the neurological interface, relaying in a bidirectional way, informations between the digestive tract and the central nervous system (CNS).
Visceral information can thus modulate the functionnement of CNS's areas involved in pain management but also in the management of emotional and cognitive behaviours. Yet, numerous work demonstrate the existence of a dysfunction of the ANS during Crohn's disease, with a dysautonomia of the sympatho-vagal balance.
Human brain respond by advance before and during the application of a painful stimulus that enable the organism to regulate its nociceptive system in order to handle the aversive stimulus incoming, via the activation of brin areas managing the pain, or the raise of pain awareness.
The uncertain and not predictable nature of a painful crisis and/or an inflammatory relapse in a chronic disease like Crohn's disease can be the origin of an anticipating apprehension and anxiety, that could influence visceral perception (increasing it). Nevertheless, only few studies exists about the differential role of certain or uncertain anticipation of the pain, despite the fact that they are associated to different emotional, cognitive and behavioral responses, and the effect of anticipation on painful visceral perception, have not yet been studied for parents in remission of Crohn's disease.
The main goal is to search during certain and uncertain visceral anticipation, induced by distension of an intra-rectal balloon for persons suffering from Crohn's disease in remission, compared to control subjects, with an MRI functional study
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | Behavioral: Psychological tests, Device: Magnetic Resonance Imaging, Behavioral: Heart Rate Variability22 persons. |
| Patients with Crohn's disease | – | Behavioral: Psychological tests, Device: Magnetic Resonance Imaging, Behavioral: Heart Rate Variability22 patients. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients with Crohn's disease
Key inclusion criteria (20 listed)
- For patients :
- For healthy volunteers
Key exclusion criteria (13 listed)
- Subjet under 18 years and more than 60 years.
- Counter-argument for MRI : presence of intra-corporeal ferro-magnetic particles, claustrophobia.
- Existence of a severe condition on general level (cardiac, respiratory, hematological, renal, hepatic, cancerous).
- Existence of an organic digestive affection (gastritis, gallstones, duodenal ulcer, megacolon, inflammatory colitis).
- Existence or history malignant gastrointestinal condition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychological testsRelated to affective and cognitive dimensions of pain. | Behavioural | Healthy volunteers, Patients with Crohn's disease |
| Magnetic Resonance ImagingAlso: MRIWith a certain or uncertain anticipation phase of distension (warning light) followed or not by a rectal distension at the pain threshold previously determined, and then a retrospective quotation of pain during distension and the fear of pain induced by anticipation. Structural MRI and rest of functional connectivity measure MRI. With measure of heart rate variability. | Device | Healthy volunteers, Patients with Crohn's disease |
| Heart Rate VariabilityAlso: HRVDuring MRI session, from the electrocardiographic signal. (measure of variations on R-R interval in milliseconds ms). | Behavioural | Healthy volunteers, Patients with Crohn's disease |
Primary outcome
Magnetic Resonance Imaging
Time frame: 30 minutes
Activation of cortical cerebral structures involved in visceral pain and communication paths between them With a certain or uncertain anticipation phase of distension (warning light) followed or not by a rectal distension at the pain threshold previously determined, and then a retrospective quotation of pain during distension and the fear of pain induced by anticipation. Structural MRI and rest of functional connectivity measure MRI. With measure of heart rate variability.
Heart Rate Variability
Time frame: 30 minutes
During MRI session, from the electrocardiographic signal. (measure of variations on R-R interval in milliseconds ms).
Psychological tests
Time frame: 45 minutes
Related to affective and cognitive dimensions of pain : Questionnaire of personality inventory NEO-FFI (Bouvard, 2005)
Psychological tests
Time frame: 45 minutes
Related to affective and cognitive dimensions of pain : Questionnaire of depressive symptomatology CES-D (Center for Epidemiologic Studies-Depression Scale; Radloff, 1977)
Psychological tests
Time frame: 45 minutes
Related to affective and cognitive dimensions of pain : Anxiety inventory (STAI-Y of Spielberger)
Psychological tests
Time frame: 45 minutes
Related to affective and cognitive dimensions of pain : Pain Catastrophizing Scale of Sullivan 1995
Psychological tests
Time frame: 45 minutes
Related to affective and cognitive dimensions of pain : Pain Anxiety Symptoms Scale of Cracken 1992
Psychological tests
Time frame: 45 minutes
Related to affective and cognitive dimensions of pain : Fear of Pain Questionnaire of McNeil andRainwater ; 1998
Psychological tests
Time frame: 45 minutes
Related to affective and cognitive dimensions of pain : Visceral Sensitivity Index of Labus; 2004
Psychological tests
Time frame: 45 minutes
Related to affective and cognitive dimensions of pain : Questionnaire of Mindfulness, Walach 2006
Psychological tests
Time frame: 45 minutes
Related to affective and cognitive dimensions of pain : Questionnaire for uncertainty intolerance (Freeston 1994)
Psychological tests
Time frame: 45 minutes
Related to affective and cognitive dimensions of pain : The Illness Attitude Scales, Dammen 1999
Psychological tests
Time frame: 45 minutes
Related to affective and cognitive dimensions of pain : Childhood Trauma Questionnaire of Bernstein 2003
Psychological tests
Time frame: 45 minutes
Related to affective and cognitive dimensions of pain : Ways of Coping Checklist Revised, adapted in French by Cousson 1996
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2016.
- Background: PubMed 16399673Achard S, Salvador R, Whitcher B, Suckling J, Bullmore E. A resilient, low-frequency, small-world human brain functional network with highly connected association cortical hubs. J Neurosci. 2006 Jan 4;26(1):63-72. doi: 10.1523/JNEUROSCI.3874-05.2006.
- Background: PubMed 8899636Al-Chaer ED, Lawand NB, Westlund KN, Willis WD. Visceral nociceptive input into the ventral posterolateral nucleus of the thalamus: a new function for the dorsal column pathway. J Neurophysiol. 1996 Oct;76(4):2661-74. doi: 10.1152/jn.1996.76.4.2661.
- Background: PubMed 10588119Baciu MV, Bonaz BL, Papillon E, Bost RA, Le Bas JF, Fournet J, Segebarth CM. Central processing of rectal pain: a functional MR imaging study. AJNR Am J Neuroradiol. 1999 Nov-Dec;20(10):1920-4.
- Background: PubMed 19818785Baert F, Moortgat L, Van Assche G, Caenepeel P, Vergauwe P, De Vos M, Stokkers P, Hommes D, Rutgeerts P, Vermeire S, D'Haens G; Belgian Inflammatory Bowel Disease Research Group; North-Holland Gut Club. Mucosal healing predicts sustained clinical remission in patients with early-stage Crohn's disease. Gastroenterology. 2010 Feb;138(2):463-8; quiz e10-1. doi: 10.1053/j.gastro.2009.09.056. Epub 2009 Oct 8.
- Background: PubMed 8412366Benarroch EE. The central autonomic network: functional organization, dysfunction, and perspective. Mayo Clin Proc. 1993 Oct;68(10):988-1001. doi: 10.1016/s0025-6196(12)62272-1.
- Background: PubMed 18184777Berman SM, Naliboff BD, Suyenobu B, Labus JS, Stains J, Ohning G, Kilpatrick L, Bueller JA, Ruby K, Jarcho J, Mayer EA. Reduced brainstem inhibition during anticipated pelvic visceral pain correlates with enhanced brain response to the visceral stimulus in women with irritable bowel syndrome. J Neurosci. 2008 Jan 9;28(2):349-59. doi: 10.1523/JNEUROSCI.2500-07.2008.
- Background: PubMed 12615092Bernstein DP, Stein JA, Newcomb MD, Walker E, Pogge D, Ahluvalia T, Stokes J, Handelsman L, Medrano M, Desmond D, Zule W. Development and validation of a brief screening version of the Childhood Trauma Questionnaire. Child Abuse Negl. 2003 Feb;27(2):169-90. doi: 10.1016/s0145-2134(02)00541-0.
- Background: PubMed 1248701Best WR, Becktel JM, Singleton JW, Kern F Jr. Development of a Crohn's disease activity index. National Cooperative Crohn's Disease Study. Gastroenterology. 1976 Mar;70(3):439-44.
- Background: PubMed 20176931Biswal BB, Mennes M, Zuo XN, Gohel S, Kelly C, Smith SM, Beckmann CF, Adelstein JS, Buckner RL, Colcombe S, Dogonowski AM, Ernst M, Fair D, Hampson M, Hoptman MJ, Hyde JS, Kiviniemi VJ, Kotter R, Li SJ, Lin CP, Lowe MJ, Mackay C, Madden DJ, Madsen KH, Margulies DS, Mayberg HS, McMahon K, Monk CS, Mostofsky SH, Nagel BJ, Pekar JJ, Peltier SJ, Petersen SE, Riedl V, Rombouts SA, Rypma B, Schlaggar BL, Schmidt S, Seidler RD, Siegle GJ, Sorg C, Teng GJ, Veijola J, Villringer A, Walter M, Wang L, Weng XC, Whitfield-Gabrieli S, Williamson P, Windischberger C, Zang YF, Zhang HY, Castellanos FX, Milham MP. Toward discovery science of human brain function. Proc Natl Acad Sci U S A. 2010 Mar 9;107(10):4734-9. doi: 10.1073/pnas.0911855107. Epub 2010 Feb 22.
- Background: PubMed 18390994Bitton A, Dobkin PL, Edwardes MD, Sewitch MJ, Meddings JB, Rawal S, Cohen A, Vermeire S, Dufresne L, Franchimont D, Wild GE. Predicting relapse in Crohn's disease: a biopsychosocial model. Gut. 2008 Oct;57(10):1386-92. doi: 10.1136/gut.2007.134817. Epub 2008 Apr 7.
- Background: PubMed 20045701Blankstein U, Chen J, Diamant NE, Davis KD. Altered brain structure in irritable bowel syndrome: potential contributions of pre-existing and disease-driven factors. Gastroenterology. 2010 May;138(5):1783-9. doi: 10.1053/j.gastro.2009.12.043. Epub 2010 Jan 4.
- Background: PubMed 7860779Bonaz B, Plourde V, Tache Y. Abdominal surgery induces Fos immunoreactivity in the rat brain. J Comp Neurol. 1994 Nov 8;349(2):212-22. doi: 10.1002/cne.903490205.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruno Bonaz, Professor principal investigator
Grenoble Hospital University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bruno Bonaz, Professor (04.76.76.55.97, BBonaz@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Magnetic Resonance Imaging (time frame: 30 minutes). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02874495, which also lists 86 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2016.