Clinical trial NCT01488214: Neuropsychiatric Scleroderma Study: Systematic Evaluation of Neuropsychiatric Involvement in Systemic Sclerosis
Official title: Assessment of Neuropsychiatric Involvement in Systemic Sclerosis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Systemic Sclerosis
Keywords: Systemic Sclerosis
neuropsychiatric manifestations
magnetic resonance imaging
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2011-12-08
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* Male or female between 18 and 65 yo
* With scleroderma (American College of Rheumatology and/or Leroy et Medsger)
* Informed consent given

Exclusion Criteria:

* Other auto-immune disease
* non french native speakers
* severe arterial hypertension
* diabetes
* anemia
* renal insufficiency
* 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

Primary outcomes:
measure: Odds-ratio between neuropsychiatric manifestations and magnetic resonance imaging abnormalities
timeFrame: 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital
state: Calvados
city: Lille
country: France
facility: Lille University hosiptal
state: Nord
city: Rouen
country: France
facility: Rouen University hospital
state: Seine-Maritime
city: Amiens
country: France
facility: Amiens Launay
state: Sommes
Study officials:
affiliation: Lille University Hospital
name: David Launay, MD, PhD
role: STUDY_CHAIR
affiliation: Amiens University Hospital
name: Amar Smail, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Caen
name: Boris Bienvenu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Rouen
name: Isabelle Marie, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.