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| ID | Type | Description | Link |
|---|---|---|---|
| PHRC 2009/API | Other Identifier | DHOS | |
| 2009-A01313-54 | Other Identifier | ID RCB number, ANSM |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Scleroderma patient | Experimental | Evaluation of Scleroderma patient |
|
| Healthy subjects | Placebo Comparator | Evaluation of healthy subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic resonance Imaging | Other | Magnetic resonance Imaging Assessment |
|
| 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 |
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Launay, MD, PhD | University Hospital, Lille | Study Chair |
| Amar Smail, MD | Amiens University Hospital | Principal Investigator |
| Boris Bienvenu, MD, PhD | University Hospital, Caen | Principal Investigator |
| Isabelle Marie, MD, PhD | University Hospital, Rouen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Caen University Hospital | Caen | Calvados | 14000 | France | ||
| Lille University hosiptal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16960939 | Result | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D012595 | Scleroderma, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| D011570 | Psychiatry |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D001525 | Behavioral Sciences |
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| Lille |
| Nord |
| 59000 |
| France |
| Rouen University hospital | Rouen | Seine-Maritime | 76 000 | France |
| Amiens Launay | Amiens | Sommes | 80 000 | France |
| D004191 | Behavioral Disciplines and Activities |