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

Assessment of Neuropsychiatric Involvement in Systemic Sclerosis.

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.

Study Overview

• Status: Completed
• Conditions: Systemic Sclerosis
• Intervention / Treatment: Other: Magnetic resonance Imaging

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Calvados
    • Caen, Calvados, France, 14000
      • Caen University Hospital
  • Nord
    • Lille, Nord, France, 59000
      • Lille University hosiptal
  • Seine-Maritime
    • Rouen, Seine-Maritime, France, 76 000
      • Rouen University Hospital
  • Sommes
    • Amiens, Sommes, France, 80 000
      • Amiens Launay

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Scleroderma patient; Evaluation of Scleroderma patient	Other: Magnetic resonance Imaging; Magnetic resonance Imaging Assessment; Other Names: Cognitive, psychiatric and neurological evaluation
Placebo Comparator: Healthy subjects; Evaluation of healthy subjects	Other: Magnetic resonance Imaging; Magnetic resonance Imaging Assessment; Other Names: Cognitive, psychiatric and neurological evaluation

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Isabelle Marie, MD, PhD, Rouen University Hospital; Study Chair: David Launay, MD, PhD, Lille University Hospital; Principal Investigator: Amar Smail, MD, Amiens University Hospital; Principal Investigator: Boris Bienvenu, MD, PhD, University Hospital, Caen

Publications and helpful links

General Publications

• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2011
• Primary Completion (Actual): October 24, 2017
• Study Completion (Actual): October 24, 2017

Study Registration Dates

• First Submitted: November 25, 2011
• First Submitted That Met QC Criteria: December 7, 2011
• First Posted (Estimate): December 8, 2011

Study Record Updates

• Last Update Posted (Actual): November 9, 2017
• Last Update Submitted That Met QC Criteria: November 8, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: magnetic resonance imaging; Systemic Sclerosis; neuropsychiatric manifestations
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Connective Tissue Diseases; Sclerosis; Scleroderma, Systemic; Scleroderma, Diffuse
• Other Study ID Numbers: 2009_10; PHRC 2009/API (Other Identifier: DHOS); 2009-A01313-54 (Other Identifier: ID RCB number, ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No