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Anticipation Effect on Painful Phenomenons Linked to Rectal Distension for Patients With a Crohn's Disease in Remission

NCT02874495 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 44

Last updated 2016-08-22

No results posted yet for this study

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. 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

Conditions

Interventions

BEHAVIORAL

Psychological tests

Related to affective and cognitive dimensions of pain.

DEVICE

Magnetic Resonance Imaging

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.

BEHAVIORAL

Heart Rate Variability

During MRI session, from the electrocardiographic signal. (measure of variations on R-R interval in milliseconds ms).

Sponsors & Collaborators

  • University Hospital, Grenoble

    lead OTHER

Principal Investigators

  • Bruno Bonaz, Professor · Grenoble Hospital University

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2017-04-30
Completion
2017-04-30

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02874495 on ClinicalTrials.gov