ItchPRURIMNCT02828787
Central Mechanisms of Chronic Pruritus: Functional and Structural Brain Imaging.
A study testing MRI in people with Itch, run by University Hospital, Brest at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Itch
- What is being tested?
- MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 2 sitesFrance
- Study dates
- 16 Jan 2017to 31 May 2018
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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):
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- 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.
Trial locations and contacts
2 sites in 1 country.
About this study
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.
Read the 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).
- Conditions
- Itch
- Being tested
- MRI
- Medical subject headings
- Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Urticaria | Experimental | 15 patients with urticaria Receives: Other: MRI |
| Psoriasis | Experimental | 15 patients with psoriasis Receives: Other: MRI |
| healthy | Other | 15 healthy control subjects Receives: Other: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study start16 Jan 2017
- Primary completion31 May 2018
- Study completion31 May 2018
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ItchStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02828787
- Sponsor's protocol ID
- RB 15.212 PRURIM
- Acronym
- PRURIM
- Status last verified
- Nov 2020
- First submitted
- 7 Jul 2016
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Mechanisms of Chronic Pruritus: Functional and Structural Brain Imaging.
- ClinicalTrials.gov ID
- NCT02828787
- Acronym / sponsor ID
- PRURIM / RB 15.212 PRURIM
- Conditions
- Itch
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 16 Jan 2017 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 12 Jul 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.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Urticaria | Experimental | Other: MRI15 patients with urticaria |
| Psoriasis | Experimental | Other: MRI15 patients with psoriasis |
| healthy | Other | Other: MRI15 healthy control subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- In connection with the award of an MRI namely:
- In connection with the mode of presentation of stimuli (video):
- In connection with the administrative regulations:
- If no pruritus is induced during the first session, it will be a criterion for non inclusion for the second session.
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 |
|---|---|---|
| MRIThe 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. | Other | Psoriasis, Urticaria, healthy |
Primary outcome
brain areas activated during a mentally induced pruritus in 3 different populations
Time frame: 1 year
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 secondary outcome
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
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Itch, run by University Hospital, Brest at 2 sites 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 6 inclusion and 11 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: stopped early, as of the sponsor's last update on 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
brain areas activated during a mentally induced pruritus in 3 different populations (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Nov 2020.