Neuropsychiatric Scleroderma Study: Systematic Evaluation of Neuropsychiatric Involvement in Systemic Sclerosis (NeuroScS)

University Hospital, Lille

Status: Completed

Conditions: Systemic Sclerosis

Treatments: Other: Magnetic resonance Imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT01488214

2009-A01313-54 (Other Identifier)

2009_10

PHRC 2009/API (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 108 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 2 patient groups, including a placebo group

Scleroderma patient

Experimental group

Description:

Evaluation of Scleroderma patient

Treatment:

Other: Magnetic resonance Imaging

Healthy subjects

Placebo Comparator group

Description:

Evaluation of healthy subjects

Treatment:

Other: Magnetic resonance Imaging