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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by University Hospital, Lille.
Recruitment status was  Recruiting
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

November 25, 2011
January 3, 2012
December 2010
December 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01488214 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Neuropsychiatric Scleroderma Study: Systematic Evaluation of Neuropsychiatric Involvement in Systemic Sclerosis
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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Systemic Sclerosis
Other: Magnetic resonance Imaging
Magnetic resonance Imaging Assessment
Other Name: Cognitive, psychiatric and neurological evaluation
  • Experimental: Scleroderma patient
    Evaluation of Scleroderma patient
    Intervention: Other: Magnetic resonance Imaging
  • Active Comparator: Healthy subjects
    Evaluation of healthy subjects
    Intervention: Other: Magnetic resonance Imaging
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
108
June 2013
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 64 Years
Yes
Contact: David Launay, MD, PhD + 33 (0) 3 20 44 50 48 ext + 33 david.launay@chru-lille.fr
France
 
NCT01488214
2009-A01313-54, 2009_10, PHRC 2009/API
No
University Hospital, Lille
University Hospital, Lille
Not Provided
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
University Hospital, Lille
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP