A new clinical trial assessing neuropsychiatric complications in patients with systemic sclerosis — like depression and cognitive problems — is starting in France and currently recruiting patients.
Until recently, systemic sclerosis (often also referred to as scleroderma) — a connective tissue disorder — was thought to spare the central nervous system (CNS). Neurological symptoms secondary to CNS involvement are very rare in these patients, although the prevalence of depression and cognitive impairment in people with systemic sclerosis ranges from 17% to 65%, a number much higher than that observed in the general population.
Brain calcifications and hyper-intense white matter signals (leukoaraiosis) have also been documented in systemic sclerosis patients at a higher incidence than in control populations, with evidence from studies revealing that severe leukoaraiosis lesions are associated with severe vascular manifestations in systemic sclerosis.
The new clinical trial is assessing if morphological CNS abnormalities could be linked to neuropsychiatric ailments.
The “Neuropsychiatric Scleroderma Study: Systematic Evaluation of Neuropsychiatric Involvement in Systemic Sclerosis (NeuroScS)” (NCT01488214), sponsored by the University Hospital in Lille, is recruiting patients of both genders, ages 18 to 64, with a clinical diagnosis of scleroderma (according to the American College of Rheumatology and/or Leroy et Medsger criteria).
Up to 108 people are expected to take part. Patients enrolled will undergo a magnetic resonance imaging (MRI) assessment as well as a cognitive, psychiatric, and neurological evaluation.
The primary endpoint of the trial is to examine a possible link between neuropsychiatric manifestations and CNS involvement in systemic sclerosis as assessed by MRI. Secondary endpoints include assessing the frequency of neuropsychiatric manifestations, comparing CNS differences between scleroderma patients and healthy subjects. CNS involvement and neuropsychiatric manifestations will be systematically assessed through imaging techniques and questionnaires.
More information on the clinical trial, including enrollment information, is available by contacting the study’s principal investigator: David Launay, MD, by calling + 33 (0) 3 20 44 50 48, ext + 33, or by emailing him at firstname.lastname@example.org. A list of the locations in France where the trial is taking place can be found here.
Systemic sclerosis, a progressive and multisystem connective tissue disorder, is characterized by skin and visceral fibrosis and obliterative microvascular abnormalities. In this autoimmune disorder, the immune system attacks healthy tissue because it mistakes it as a foreign substance or infection.