NCT01488214

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 16, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2011

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 8, 2011

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2017

Completed
Last Updated

November 9, 2017

Status Verified

November 1, 2017

Enrollment Period

6.7 years

First QC Date

November 25, 2011

Last Update Submit

November 8, 2017

Conditions

Systemic Sclerosis

Keywords

Systemic Sclerosisneuropsychiatric manifestationsmagnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

  • Odds-ratio between neuropsychiatric manifestations and magnetic resonance imaging abnormalities

    Odds-ratio between neuropsychiatric manifestations and magnetic resonance imaging abnormalities

    5 weeks

Study Arms (2)

Scleroderma patient

EXPERIMENTAL

Evaluation of Scleroderma patient

Other: Magnetic resonance Imaging

Healthy subjects

PLACEBO COMPARATOR

Evaluation of healthy subjects

Other: Magnetic resonance Imaging

Interventions

Magnetic resonance ImagingOTHER

Magnetic resonance Imaging Assessment

Also known as: Cognitive, psychiatric and neurological evaluation
Healthy subjectsScleroderma patient

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female between 18 and 65 yo
  • With scleroderma (American College of Rheumatology and/or Leroy et Medsger)
  • Informed consent given

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Caen University Hospital

Caen, Calvados, 14000, France

Location

Lille University hosiptal

Lille, Nord, 59000, France

Location

Rouen University hospital

Rouen, Seine-Maritime, 76 000, France

Location

Amiens Launay

Amiens, Sommes, 80 000, France

Location

Related Publications (1)

  • 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.

    PMID: 16960939RESULT

Related Links

MeSH Terms

Conditions

Scleroderma, Systemic

Interventions

Magnetic Resonance SpectroscopyPsychiatry

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative TechniquesBehavioral SciencesBehavioral Disciplines and Activities

Study Officials

  • David Launay, MD, PhD

    Lille University Hospital

    STUDY CHAIR

  • Amar Smail, MD

    Amiens University Hospital

    PRINCIPAL INVESTIGATOR

  • Boris Bienvenu, MD, PhD

    University Hospital, Caen

    PRINCIPAL INVESTIGATOR

  • Isabelle Marie, MD, PhD

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2011

First Posted

December 8, 2011

Study Start

February 16, 2011

Primary Completion

October 24, 2017

Study Completion

October 24, 2017

Last Updated

November 9, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(4)