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

This study is currently recruiting participants.
Verified May 2017 by University Hospital, Lille
Sponsor:
ClinicalTrials.gov Identifier:
NCT01488214
First Posted: December 8, 2011
Last Update Posted: May 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Lille
  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: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Assessment of Neuropsychiatric Involvement in Systemic Sclerosis.

Resource links provided by NLM:


Further study details as provided by University Hospital, Lille:

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


Estimated Enrollment: 108
Actual Study Start Date: February 16, 2011
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (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
Placebo Comparator: Healthy subjects
Evaluation of healthy subjects
Other: Magnetic resonance Imaging
Magnetic resonance Imaging Assessment
Other Name: Cognitive, psychiatric and neurological evaluation

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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


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 Active, not recruiting
Caen, Calvados, France, 14000
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 Completed
Rouen, Seine-Maritime, France, 76 000
Amiens Launay Active, not recruiting
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
  More Information

Additional Information:
Publications:
Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT01488214     History of Changes
Other Study ID Numbers: 2009-A01313-54
2009_10 ( Other Identifier: sponsor )
PHRC 2009/API ( Other Identifier: DHOS )
First Submitted: November 25, 2011
First Posted: December 8, 2011
Last Update Posted: May 19, 2017
Last Verified: May 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