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

Primary Purpose

Systemic Sclerosis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Magnetic resonance Imaging
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Systemic Sclerosis focused on measuring Systemic Sclerosis, neuropsychiatric manifestations, magnetic resonance imaging

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Caen University Hospital
  • Lille University hosiptal
  • Rouen University hospital
  • Amiens Launay

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Scleroderma patient

Healthy subjects

Arm Description

Evaluation of Scleroderma patient

Evaluation of healthy subjects

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 25, 2011
Last Updated
November 8, 2017
Sponsor
University Hospital, Lille
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1. Study Identification

Unique Protocol Identification Number
NCT01488214
Brief Title
Neuropsychiatric Scleroderma Study: Systematic Evaluation of Neuropsychiatric Involvement in Systemic Sclerosis
Acronym
NeuroScS
Official Title
Assessment of Neuropsychiatric Involvement in Systemic Sclerosis.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
February 16, 2011 (Actual)
Primary Completion Date
October 24, 2017 (Actual)
Study Completion Date
October 24, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Sclerosis
Keywords
Systemic Sclerosis, neuropsychiatric manifestations, magnetic resonance imaging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Scleroderma patient
Arm Type
Experimental
Arm Description
Evaluation of Scleroderma patient
Arm Title
Healthy subjects
Arm Type
Placebo Comparator
Arm Description
Evaluation of healthy subjects
Intervention Type
Other
Intervention Name(s)
Magnetic resonance Imaging
Other Intervention Name(s)
Cognitive, psychiatric and neurological evaluation
Intervention Description
Magnetic resonance Imaging Assessment
Primary Outcome Measure Information:
Title
Odds-ratio between neuropsychiatric manifestations and magnetic resonance imaging abnormalities
Description
Odds-ratio between neuropsychiatric manifestations and magnetic resonance imaging abnormalities
Time Frame
5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Launay, MD, PhD
Organizational Affiliation
Lille University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Amar Smail, MD
Organizational Affiliation
Amiens University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Boris Bienvenu, MD, PhD
Organizational Affiliation
University Hospital, Caen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Isabelle Marie, MD, PhD
Organizational Affiliation
Rouen University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Caen University Hospital
City
Caen
State/Province
Calvados
ZIP/Postal Code
14000
Country
France
Facility Name
Lille University hosiptal
City
Lille
State/Province
Nord
ZIP/Postal Code
59000
Country
France
Facility Name
Rouen University hospital
City
Rouen
State/Province
Seine-Maritime
ZIP/Postal Code
76 000
Country
France
Facility Name
Amiens Launay
City
Amiens
State/Province
Sommes
ZIP/Postal Code
80 000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16960939
Citation
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.
Results Reference
result
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/16960939
Description
Related Info

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Neuropsychiatric Scleroderma Study: Systematic Evaluation of Neuropsychiatric Involvement in Systemic Sclerosis

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