Systemic SclerosisNeuroScSNCT01488214
Neuropsychiatric Scleroderma Study: Systematic Evaluation of Neuropsychiatric Involvement in Systemic Sclerosis
A study testing Magnetic resonance Imaging in people with Systemic Sclerosis, run by University Hospital, Lille at 4 sites in France.
Trial summary
Systemic sclerosis is a rare disease with vascular involvement and systemic fibrosis. This disease is usually thought to spare central nervous system. However, neuropsychiatric manifestations like depression and cognitive functions impairment seem to be frequent. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Systemic Sclerosis
- What is being tested?
- Magnetic resonance Imaging
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 4 sitesFrance
- Study dates
- 16 Feb 2011to 24 Oct 2017
- 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 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female between 18 and 65 yo
- With scleroderma (American College of Rheumatology and/or Leroy et Medsger)
- Informed consent given
Who cannot join
- Other auto-immune disease
- non french native speakers
- severe arterial hypertension
- diabetes
- anemia
- renal insufficiency
Show all 11Show fewer
- cranial trauma
- history of neurological disorder or neurotoxic treatment
- pregnancy or breast feeding
- impossibility or non compliance to perform the protocol flow chart
- contra indications to MRI
Trial locations and contacts
4 sites in 1 country.
France4 sites
Amiens Launay
Amiens, Sommes, 80 000
Caen University Hospital
Caen, Calvados, 14000
Lille University hosiptal
Lille, Nord, 59000
Rouen University hospital
Rouen, Seine-Maritime, 76 000
About this study
Official title: Assessment of Neuropsychiatric Involvement in Systemic Sclerosis.
Systemic sclerosis is a rare disease with vascular involvement and systemic fibrosis. This disease is usually thought to spare central nervous system. However, neuropsychiatric manifestations like depression and cognitive functions impairment seem to be frequent. Pathophysiology of this neuropsychiatric manifestations is currently unknown. White matter hyperintensities have been reported suggested CNS vascular manifestations in systemic sclerosis. Whether this CNS vascular involvement plays a role in neuropsychiatric manifestations in systemic sclerosis is unknown. The primary objective of this prospective and multicentre study is to assess a link between neuropsychiatric manifestations and CNS involvement in systemic sclerosis. Secondary objectives are to assess the frequency of neuropsychiatric manifestations, to compare central nervous system abnormality between scleroderma patient and healthy subjects. Central nervous system involvement and neuropsychiatric manifestations will be systematically assessed through central nervous system imaging and questionnaires.
- Conditions
- Systemic Sclerosis
- Being tested
- Magnetic resonance Imaging
- Keywords
- Systemic Sclerosis, neuropsychiatric manifestations, magnetic resonance imaging
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance ImagingOther
Also called Cognitive, psychiatric and neurological evaluation
Magnetic resonance Imaging Assessment
| Study group | Role | What they receive |
|---|---|---|
| Scleroderma patient | Experimental | Evaluation of Scleroderma patient Receives: Other: Magnetic resonance Imaging |
| Healthy subjects | Placebo comparator | Evaluation of healthy subjects Receives: Other: Magnetic resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Odds-ratio between neuropsychiatric manifestations and magnetic resonance imaging abnormalities
Odds-ratio between neuropsychiatric manifestations and magnetic resonance imaging abnormalities
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2011 (estimated)
- Study start16 Feb 2011
- Primary completion24 Oct 2017
- Study completion24 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Launay, MD, PhD, Study chair, University Hospital, LilleAmar Smail, MD, Principal investigator, Amiens University HospitalBoris Bienvenu, MD, PhD, Principal investigator, University Hospital, CaenIsabelle Marie, MD, PhD, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01488214
- Sponsor's protocol ID
- 2009_10
- Other IDs
- PHRC 2009/API, 2009-A01313-54
- Acronym
- NeuroScS
- Status last verified
- Nov 2017
- First submitted
- 25 Nov 2011
- Last updated
- 9 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Launay D, Remy-Jardin M, Michon-Pasturel U, Mastora I, Hachulla E, Lambert M, Delannoy V, Queyrel V, Duhamel A, Matran R, De Groote P, Hatron PY. High resolution computed tomography in fibrosing alveolitis associated with systemic sclerosis. J Rheumatol. 2006 Sep;33(9):1789-801.
PubMed 16960939
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Neuropsychiatric Involvement in Systemic Sclerosis.
- ClinicalTrials.gov ID
- NCT01488214
- Acronym / sponsor ID
- NeuroScS / 2009_10
- Conditions
- Systemic Sclerosis
- Keywords
- Systemic Sclerosis, neuropsychiatric manifestations, magnetic resonance imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 16 Feb 2011 (actual)
- Primary completion
- 24 Oct 2017 (actual)
- Study completion
- 24 Oct 2017 (actual)
- First posted
- 8 Dec 2011 (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.
Systemic sclerosis is a rare disease with vascular involvement and systemic fibrosis. This disease is usually thought to spare central nervous system. However, neuropsychiatric manifestations like depression and cognitive functions impairment seem to be frequent. Pathophysiology of this neuropsychiatric manifestations is currently unknown. White matter hyperintensities have been reported suggested CNS vascular manifestations in systemic sclerosis. Whether this CNS vascular involvement plays a role in neuropsychiatric manifestations in systemic sclerosis is unknown. The primary objective of this prospective and multicentre study is to assess a link between neuropsychiatric manifestations and CNS involvement in systemic sclerosis. Secondary objectives are to assess the frequency of neuropsychiatric manifestations, to compare central nervous system abnormality between scleroderma patient and healthy subjects. Central nervous system involvement and neuropsychiatric manifestations will be systematically assessed through central nervous system imaging and questionnaires.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scleroderma patient | Experimental | Other: Magnetic resonance ImagingEvaluation of Scleroderma patient |
| Healthy subjects | Placebo comparator | Other: Magnetic resonance ImagingEvaluation of healthy subjects |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male or female between 18 and 65 yo
- With scleroderma (American College of Rheumatology and/or Leroy et Medsger)
- Informed consent given
Key exclusion criteria (11 listed)
- Other auto-immune disease
- non french native speakers
- severe arterial hypertension
- diabetes
- anemia
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 |
|---|---|---|
| Magnetic resonance ImagingAlso: Cognitive, psychiatric and neurological evaluationMagnetic resonance Imaging Assessment | Other | Healthy subjects, Scleroderma patient |
Primary outcome
Odds-ratio between neuropsychiatric manifestations and magnetic resonance imaging abnormalities
Time frame: 5 weeks
Odds-ratio between neuropsychiatric manifestations and magnetic resonance imaging abnormalities
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2017.
- Results publication: PubMed 16960939Launay D, Remy-Jardin M, Michon-Pasturel U, Mastora I, Hachulla E, Lambert M, Delannoy V, Queyrel V, Duhamel A, Matran R, De Groote P, Hatron PY. High resolution computed tomography in fibrosing alveolitis associated with systemic sclerosis. J Rheumatol. 2006 Sep;33(9):1789-801.
- Related InfoLink provided by the sponsor.
- 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.
David Launay, MD, PhD study chair
University Hospital, Lille
Amar Smail, MD principal investigator
Amiens University Hospital
Boris Bienvenu, MD, PhD principal investigator
University Hospital, Caen
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic resonance Imaging in people with Systemic Sclerosis, run by University Hospital, Lille at 4 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 3 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: finished, as of the sponsor's last update on 9 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Odds-ratio between neuropsychiatric manifestations and magnetic resonance imaging abnormalities (time frame: 5 weeks). 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 NCT01488214, which also lists 1 linked publication.
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 9 Nov 2017.