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

Systemic Sclerosis Clinical Trial

— NeuroScS  

Official title:

Assessment of Neuropsychiatric Involvement in Systemic Sclerosis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01488214
• Other study ID #: 2009_10
• Secondary ID: PHRC 2009/API200
• Status: Completed
• Phase: N/A
• First received: November 25, 2011
• Last updated: November 8, 2017
• Start date: February 16, 2011
• Est. completion date: October 24, 2017

Study information

• Verified date: November 2017
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: October 24, 2017
• Est. primary completion date: October 24, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Intervention

Other:
• Magnetic resonance Imaging
Magnetic resonance Imaging Assessment

Locations

Country	Name	City	State
France	Amiens Launay	Amiens	Sommes
France	Caen University Hospital	Caen	Calvados
France	Lille University hosiptal	Lille	Nord
France	Rouen University hospital	Rouen	Seine-Maritime

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Odds-ratio between neuropsychiatric manifestations and magnetic resonance imaging abnormalities	Odds-ratio between neuropsychiatric manifestations and magnetic resonance imaging abnormalities	5 weeks

External Links

•   Link