Central Mechanisms of Chronic Pruritus: Functional and Structural Brain Imaging. (PRURIM)
Primary Purpose
Itch
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Itch
Eligibility Criteria
Inclusion Criteria:
- Or patient affected by psoriasis presenting a pruritus of more than 6 weeks
- Or patient affected by urticaria presenting a pruritus of more than 6 weeks
- Or subject without dermatosis and not presenting chronic pruritus.
- Major
- Able to provide written informed consent
- Affiliated to the Social Security
Exclusion Criteria:
In connection with the award of an MRI namely:
- The presence of implanted medical equipment susceptible to the magnetic field of MRI,
- Claustrophobia
- Medication, treatment and / or substances that could alter or modify brain function
- Pregnancy
In connection with the mode of presentation of stimuli (video):
- An uncorrected visual disorder not allowing to view videos
In connection with the administrative regulations:
- Persons under 18
- Major Persons subject to legal protection (backup justice, trusteeship, guardianship), persons deprived of liberty.
If no pruritus is induced during the first session, it will be a criterion for non inclusion for the second session.
Sites / Locations
- Laurent MISERY
- CHRU de Brest
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Other
Arm Label
Urticaria
Psoriasis
healthy
Arm Description
15 patients with urticaria
15 patients with psoriasis
15 healthy control subjects
Outcomes
Primary Outcome Measures
brain areas activated during a mentally induced pruritus in 3 different populations
The primary endpoint is to highlight fMRI brain areas activated during a mentally induced pruritus in 3 different populations: healthy subjects (no pre-existing pruritus), patients with chronic urticaria (pruritus related to histaminergic pathway), and psoriasis patients (activation pathway pruritus probably PAR2-ergic but to be confirmed by the study).
Secondary Outcome Measures
index, form the combination the better able to explain the membership of an individual (individual analysis) to a pathological community or not.
The secondary outcome is to verify that data collected, once grouped and established in index, form the combination the better able to explain the membership of an individual (individual analysis) to a pathological community or not.
Full Information
NCT ID
NCT02828787
First Posted
July 7, 2016
Last Updated
November 4, 2020
Sponsor
University Hospital, Brest
1. Study Identification
Unique Protocol Identification Number
NCT02828787
Brief Title
Central Mechanisms of Chronic Pruritus: Functional and Structural Brain Imaging.
Acronym
PRURIM
Official Title
Central Mechanisms of Chronic Pruritus: Functional and Structural Brain Imaging.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Terminated
Why Stopped
End of the inclusion period. A late start of inclusions and reduced scanner availability meant that the number of 45 participants could not be reached.
Study Start Date
January 16, 2017 (Actual)
Primary Completion Date
May 31, 2018 (Actual)
Study Completion Date
May 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main objective of this study is to identify by functional and structural MRI which are the brain areas activated in various pruritic situations to deduct a model describing the different causes of pruritus.
The investigators are going to compare two chronic pruritus conditions (histaminergic urticaria and non histaminergic: psoriasis) to a healthy control group.
The secondary objective of this study is to specify a classification index from the physiological results obtained by brain imaging to differentiate multiple types of pruritus.
Detailed Description
Particularly invalidating in some cases, pruritus is defined as an unpleasant sensation that causes the need to scratch.
Epidemiologically, it is a common disorder as a third of the population feels in a given week. Treatment is difficult, especially as the pathophysiological mechanisms remain poorly understood, particularly in the central nervous system.
Specific pathways, or at least selective of the pruritus of transmission have been identified. From the skin to the brain, two ways exist: a histaminergic pathway (classical), and a non-histaminergic pathway (related to the activation of PAR-2 receptors by serine proteases). If urticaria belongs to the first track, the respective share of each channel is unknown to other causes of pruritus. The pruriceptors, located in the skin, transmit information by specific fibers at the spinal cord, which then project through the lateral spinothalamic tract to the thalamus. Then at midbrain and cortex, a vast network involving sensorial areas, motor and emotional areas was identified by functional neuroimaging, with activation zones which may be different depending on two channels (with overlapping zones ). The contribution to the perception of pruritus of these brain regions is the focus of current research.
A promising non-invasive method to study the pruritus channels with neuroimaging is to use the phenomenon of "contagious pruritus': seeing other people scratching, itching and sometimes scratching is induced in the observer, and the activated brain network is similar to that which is activated by pruritus usually. This phenomenon is even more important in subjects with atopic dermatitis than in healthy subjects.
In this project, the investigators plan to characterize pruritus central pathways in patients with different types of chronic pruritus compared to healthy subjects, particularly regarding the respective contributions of histaminergic pathways (pathway involved in pruritus of hives) and "PAR-2-ergic" (pathway involved in the itch of psoriasis).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Itch
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Urticaria
Arm Type
Experimental
Arm Description
15 patients with urticaria
Arm Title
Psoriasis
Arm Type
Experimental
Arm Description
15 patients with psoriasis
Arm Title
healthy
Arm Type
Other
Arm Description
15 healthy control subjects
Intervention Type
Other
Intervention Name(s)
MRI
Intervention Description
The study will take place in two phases. The first phase consists of a meeting of inclusion. During this phase, the principal investigator of the study will verify the inclusion criteria for patients using a questionnaire and an interview. Then, the effects of video on each person will be tested to verify that they well induce itch and measure it using visual analogue scales. This phase will also test the benefit of the relief by scraping and cold.
The second phase will be carried out only if the mental induction of pruritus has been possible in the first session. It involves acquiring the corresponding physiological signals fMRI. It will also be achieved during this phase an anatomical image of the brain of each participant and an image in DTI.
The phases will be carried out in this order in each participant. They will be separated at least one night.
Primary Outcome Measure Information:
Title
brain areas activated during a mentally induced pruritus in 3 different populations
Description
The primary endpoint is to highlight fMRI brain areas activated during a mentally induced pruritus in 3 different populations: healthy subjects (no pre-existing pruritus), patients with chronic urticaria (pruritus related to histaminergic pathway), and psoriasis patients (activation pathway pruritus probably PAR2-ergic but to be confirmed by the study).
Time Frame
1 year
Secondary Outcome Measure Information:
Title
index, form the combination the better able to explain the membership of an individual (individual analysis) to a pathological community or not.
Description
The secondary outcome is to verify that data collected, once grouped and established in index, form the combination the better able to explain the membership of an individual (individual analysis) to a pathological community or not.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Or patient affected by psoriasis presenting a pruritus of more than 6 weeks
Or patient affected by urticaria presenting a pruritus of more than 6 weeks
Or subject without dermatosis and not presenting chronic pruritus.
Major
Able to provide written informed consent
Affiliated to the Social Security
Exclusion Criteria:
In connection with the award of an MRI namely:
The presence of implanted medical equipment susceptible to the magnetic field of MRI,
Claustrophobia
Medication, treatment and / or substances that could alter or modify brain function
Pregnancy
In connection with the mode of presentation of stimuli (video):
- An uncorrected visual disorder not allowing to view videos
In connection with the administrative regulations:
Persons under 18
Major Persons subject to legal protection (backup justice, trusteeship, guardianship), persons deprived of liberty.
If no pruritus is induced during the first session, it will be a criterion for non inclusion for the second session.
Facility Information:
Facility Name
Laurent MISERY
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
CHRU de Brest
City
Brest
ZIP/Postal Code
29609
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Central Mechanisms of Chronic Pruritus: Functional and Structural Brain Imaging.
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