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OpenTrials
Completed

NCT Number: NCT01488214

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

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.

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Caen University Hospital, Caen, Calvados, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnetic Resonance Imaging

Other

Magnetic resonance Imaging Assessment

Other names: Cognitive, psychiatric and neurological evaluation

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

Assessment of Neuropsychiatric Involvement in Systemic Sclerosis.

Acronym: NeuroScS

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Dec 8, 2011
Registry last updated
Nov 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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