Neuropsychiatric Scleroderma Study: Systematic Evaluation of Neuropsychiatric Involvement in Systemic Sclerosis
- Conditions
- Systemic Sclerosis
- Interventions
- Other: Magnetic resonance Imaging
- Registration Number
- NCT01488214
- Lead Sponsor
- University Hospital, Lille
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 108
- Male or female between 18 and 65 yo
- With scleroderma (American College of Rheumatology and/or Leroy et Medsger)
- Informed consent given
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Healthy subjects Magnetic resonance Imaging Evaluation of healthy subjects Scleroderma patient Magnetic resonance Imaging Evaluation of Scleroderma patient
- Primary Outcome Measures
Name Time Method Odds-ratio between neuropsychiatric manifestations and magnetic resonance imaging abnormalities 5 weeks Odds-ratio between neuropsychiatric manifestations and magnetic resonance imaging abnormalities
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Lille University hosiptal
🇫🇷Lille, Nord, France
Amiens Launay
🇫🇷Amiens, Sommes, France
Caen University Hospital
🇫🇷Caen, Calvados, France
Rouen University hospital
🇫🇷Rouen, Seine-Maritime, France