Study 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.
Central Mechanisms of Chronic Pruritus: Functional and Structural Brain Imaging.
PRURIM
1 other identifier
interventional
31
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2017
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2016
CompletedFirst Posted
Study publicly available on registry
July 12, 2016
CompletedStudy Start
First participant enrolled
January 16, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2018
CompletedNovember 5, 2020
November 1, 2020
1.4 years
July 7, 2016
November 4, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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).
1 year
Secondary Outcomes (1)
index, form the combination the better able to explain the membership of an individual (individual analysis) to a pathological community or not.
1 year
Study Arms (3)
Urticaria
EXPERIMENTAL15 patients with urticaria
Psoriasis
EXPERIMENTAL15 patients with psoriasis
healthy
OTHER15 healthy control subjects
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Laurent MISERY
Brest, 29200, France
CHRU de Brest
Brest, 29609, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 7, 2016
First Posted
July 12, 2016
Study Start
January 16, 2017
Primary Completion
May 31, 2018
Study Completion
May 31, 2018
Last Updated
November 5, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share