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

This study is currently recruiting participants.
Verified November 2010 by University Hospital, Lille
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT01488214
First received: November 25, 2011
Last updated: January 3, 2012
Last verified: November 2010
History of Changes
  Purpose

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.


Condition Intervention
Systemic Sclerosis
 Other: Magnetic resonance Imaging

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Assessment of Neuropsychiatric Involvement in Systemic Sclerosis.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Lille:

Primary Outcome Measures:
  • Odds-ratio between neuropsychiatric manifestations and magnetic resonance imaging abnormalities [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Odds-ratio between neuropsychiatric manifestations and magnetic resonance imaging abnormalities


Estimated Enrollment: 108
Study Start Date: December 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Scleroderma patient
Evaluation of Scleroderma patient
 Other: Magnetic resonance Imaging
Magnetic resonance Imaging Assessment
Other Name: Cognitive, psychiatric and neurological evaluation
Active Comparator: Healthy subjects
Evaluation of healthy subjects
 Other: Magnetic resonance Imaging
Magnetic resonance Imaging Assessment
Other Name: Cognitive, psychiatric and neurological evaluation

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01488214

Contacts
Contact: David Launay, MD, PhD + 33 (0) 3 20 44 50 48 ext + 33 david.launay@chru-lille.fr

Locations
France
Caen University Hospital Not yet recruiting
Caen, Calvados, France, 14000
Contact: Boris Bienvenu, MD, PhP     +33 2 31 06 45 79 ext +33     bienvenu-b@chu-caen.fr    
Principal Investigator: Boris Bienvenu, MD, PhD            
Sub-Investigator: Abdelkader Zoulim, MD            
Sub-Investigator: Ollivier Yann, MD            
Sub-Investigator: Jonathan Boutemy, MD            
Lille University hosiptal Recruiting
Lille, Nord, France, 59000
Contact: David Launay, MD, PhD     3 20 44 42 95 ext + 33     david.launay@chru-lille.fr    
Principal Investigator: David Launay, MD, PhD            
Sub-Investigator: Pierre-Yves Hatron, Md            
Sub-Investigator: Eric Hachulla, Md, PhD            
Sub-Investigator: Marc Lambert, MD, PhD            
Sub-Investigator: Sandrine Morell-Dubois, MD            
Sub-Investigator: Olvier Cottencin, MD, PhD            
Sub-Investigator: Frederique Warembourg, MD, PhD            
Sub-Investigator: Patrick Vermersch, MD, PhD            
Sub-Investigator: Helene Zephir, MD, PhD            
Sub-Investigator: Florence Pasquier, MD, PhD            
Sub-Investigator: Christine Moroni, PhD            
Sub-Investigator: Xavier Delbeucq, PhD            
Sub-Investigator: Jean-Pierre Pruvo, MD, PhD            
Sub-Investigator: Camille Henichart, MD            
Sub-Investigator: Patrice Jissendi, MD, PhD            
Rouen University hospital Not yet recruiting
Rouen, Seine-Maritime, France, 76 000
Contact: Isabelle Marie, MD, PhD     +33 2 32 88 90 03 ext +33     isabelle.marie@chu-rouen.fr    
Principal Investigator: Isabelle Marie, MD, PhD            
Amiens Launay Not yet recruiting
Amiens, Sommes, France, 80 000
Contact: Amar Smail, Md     +33 3 22 06 60 82 030 ext +33     smail.amar@chu-amiens.fr    
Principal Investigator: Amar Smail, MD            
Sponsors and Collaborators
University Hospital, Lille
Investigators
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
Principal Investigator: Isabelle Marie, MD, PhD Rouen University Hospital
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT01488214     History of Changes
Other Study ID Numbers: 2009-A01313-54, 2009_10, PHRC 2009/API
Study First Received: November 25, 2011
Last Updated: January 3, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Lille:
Systemic Sclerosis
neuropsychiatric manifestations
magnetic resonance imaging

Additional relevant MeSH terms:
Scleroderma, Systemic
Scleroderma, Diffuse
Sclerosis
 Connective Tissue Diseases
Skin Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013