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

NCT ID: NCT01488214

Last Updated: 2017-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-16

Study Completion Date

2017-10-24

Brief Summary

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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.

Detailed Description

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Conditions

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Systemic Sclerosis

Keywords

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Systemic Sclerosis neuropsychiatric manifestations magnetic resonance imaging

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Scleroderma patient

Evaluation of Scleroderma patient

Group Type EXPERIMENTAL

Magnetic resonance Imaging

Intervention Type OTHER

Magnetic resonance Imaging Assessment

Healthy subjects

Evaluation of healthy subjects

Group Type PLACEBO_COMPARATOR

Magnetic resonance Imaging

Intervention Type OTHER

Magnetic resonance Imaging Assessment

Interventions

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Magnetic resonance Imaging

Magnetic resonance Imaging Assessment

Intervention Type OTHER

Other Intervention Names

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Cognitive, psychiatric and neurological evaluation

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Launay, MD, PhD

Role: STUDY_CHAIR

Lille University Hospital

Amar Smail, MD

Role: PRINCIPAL_INVESTIGATOR

Amiens University Hospital

Boris Bienvenu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Caen

Isabelle Marie, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Locations

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Caen University Hospital

Caen, Calvados, France

Site Status

Lille University hosiptal

Lille, Nord, France

Site Status

Rouen University hospital

Rouen, Seine-Maritime, France

Site Status

Amiens Launay

Amiens, Sommes, France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 16960939 (View on PubMed)

Related Links

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http://www.ncbi.nlm.nih.gov/pubmed/16960939

Related Info

Other Identifiers

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PHRC 2009/API

Identifier Type: OTHER

Identifier Source: secondary_id

2009-A01313-54

Identifier Type: OTHER

Identifier Source: secondary_id

2009_10

Identifier Type: -

Identifier Source: org_study_id