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

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ClinicalTrials.gov Identifier: NCT01488214
Recruitment Status : Completed
First Posted : December 8, 2011
Last Update Posted : November 9, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Brief Summary:
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 or disease Intervention/treatment Phase
Systemic Sclerosis Other: Magnetic resonance Imaging Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Assessment of Neuropsychiatric Involvement in Systemic Sclerosis.
Actual Study Start Date : February 16, 2011
Actual Primary Completion Date : October 24, 2017
Actual Study Completion Date : October 24, 2017


Arm Intervention/treatment
Experimental: Scleroderma patient
Evaluation of Scleroderma patient
Other: Magnetic resonance Imaging
Magnetic resonance Imaging Assessment
Other Name: Cognitive, psychiatric and neurological evaluation

Placebo Comparator: Healthy subjects
Evaluation of healthy subjects
Other: Magnetic resonance Imaging
Magnetic resonance Imaging Assessment
Other Name: Cognitive, psychiatric and neurological evaluation




Primary Outcome Measures :
  1. Odds-ratio between neuropsychiatric manifestations and magnetic resonance imaging abnormalities [ Time Frame: 5 weeks ]
    Odds-ratio between neuropsychiatric manifestations and magnetic resonance imaging abnormalities



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01488214


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

Additional Information:
Publications of Results:
Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT01488214     History of Changes
Other Study ID Numbers: 2009_10
PHRC 2009/API ( Other Identifier: DHOS )
2009-A01313-54 ( Other Identifier: ID RCB number, ANSM )
First Posted: December 8, 2011    Key Record Dates
Last Update Posted: November 9, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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

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