Neuropsychiatric Scleroderma Study: Systematic Evaluation of Neuropsychiatric Involvement in Systemic Sclerosis

Study Overview
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Brief Summary
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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.

Official Title
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Assessment of Neuropsychiatric Involvement in Systemic Sclerosis.

Conditions
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Systemic Sclerosis

Intervention / Treatment
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* Other: Magnetic resonance Imaging


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Scleroderma patient<br>Evaluation of Scleroderma patient | Other: Magnetic resonance Imaging<br>* Magnetic resonance Imaging Assessment<br>* Other names: Cognitive, psychiatric and neurological evaluation;|
| Placebo Comparator: Healthy subjects<br>Evaluation of healthy subjects | Other: Magnetic resonance Imaging<br>* Magnetic resonance Imaging Assessment<br>* Other names: Cognitive, psychiatric and neurological evaluation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Odds-ratio between neuropsychiatric manifestations and magnetic resonance imaging abnormalities | Odds-ratio between neuropsychiatric manifestations and magnetic resonance imaging abnormalities | 5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Systemic Sclerosis, neuropsychiatric manifestations, magnetic resonance imaging