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

Assessment of Neuropsychiatric Involvement in Systemic Sclerosis.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01488214

Acronym

NeuroScS

Enrollment

108

Registered

2011-12-08

Start date

2011-02-16

Completion date

2017-10-24

Last updated

2017-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Sclerosis

Keywords

Systemic Sclerosis, neuropsychiatric manifestations, magnetic resonance imaging

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.

Interventions

OTHERMagnetic resonance Imaging

Magnetic resonance Imaging Assessment

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026