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

Not Applicable

Completed

• Conditions: Systemic Sclerosis

• Registration Number: NCT01488214
• Lead Sponsor: University Hospital, Lille

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-16
• Study First Submitted: 2011-11-25
• Study First Submitted QC: 2011-12-07
• Study First Posted: 2011-12-08
• Primary Completion: 2017-10-24
• Study Completion: 2017-10-24
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-08
• Last Update Posted: 2017-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Odds-ratio between neuropsychiatric manifestations and magnetic resonance imaging abnormalities	5 weeks	Odds-ratio between neuropsychiatric manifestations and magnetic resonance imaging abnormalities

Trial Locations

Locations (4)

Caen University Hospital; 🇫🇷 Caen, Calvados, France

Lille University hosiptal; 🇫🇷 Lille, Nord, France

Rouen University hospital; 🇫🇷 Rouen, Seine-Maritime, France

Amiens Launay; 🇫🇷 Amiens, Sommes, France