Prospective Longitudinal 1-year Study of the Correlation Between Cogni
Prospective Longitudinal 1-year Study of the Correlation Between Cognitive Functioning in Patients With Clinically Isolated Syndrome Suggestive of Multiple Sclerosis and Disconnection in the Brain Assessed by MRI:"SCI-COG" Study
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Brain MRI - Clinical and cognitive evaluation
- Eye movement
What it measured
Main measures
Correlation between fractional anisotropy (FA) value and cognitive z scores or cognitive impairment indexes for each domains
visit 2 - 1 year after inclusion
MRI lesionsThinking and memory
Other measures (6)
Comparison of skeleton of FA between CIS patients and healthy subjects
V2 - 1 year after the inclusion
Comparison of cognitive scores at each test between CIS patients and controls
D0 and V2 - 1 year after the inclusion
Thinking and memoryProportion of patients with cognitive impairment (≥ 3 tests impaired) and correlations with anxiety, depressive syndrome and fatigue
D0 and V2 - 1 year after the inclusion
Thinking and memoryFatigueMood and sleepComparison of statistical maps of FA
D0 and V2 - 1 year after the inclusion
Thinking and memoryCorrelations between cognitive scores and mean cortical thickness and deep grey nuclei volumes in CIS patients
D0 and V2 - 1 year after the inclusion
Thinking and memoryComparison of cognitive scores at each test and eye movements scores
D0 and V2 - 1 year after the inclusion
Thinking and memoryNerve conduction tests
Who could take part
Early (CIS/RIS) · 18 and over
Show the full criteria
Inclusion criteria
* Patients: * Men and Women * ≥16 years * Fluent French speaker * Clinically isolated neurological syndrome (CIS) compatible with a demyelinating inflammatory episode within the central nervous system, potentially beginning multiple sclerosis (MS) whatever the mode of presentation * Between 60 and 180 days from the onset * At least two clinically silent lesions on their T2-weighted brain or spinal MRI scan with a size of at least 3 mm, at least one of which being cerebral, ovoid, or periventricular * Having a medical insurance * Free and informed consent signed * Controls: * Men and Women * ≥18 years * Fluent French speaker * Having a medical insurance * Free and informed consent signed
Exclusion criteria
* Patients: * Prior documented neurological episode suggestive of MS. * Other ongoing neurological diseases. * Known chronic systemic diseases as judged by the investigator (for instance: lupus, Gougerot-Sjögren, sarcoidosis, sclerodermia, Crohn disease,…). * Other causes (trauma, tumor, radiotherapy, infections, vascular diseases, neuromyelitis optica). * Current dependence on alcohol or drugs. * Dosage change, stop or start of hypnotic or anxiolytic or antidepressive treatment less than 15 days * MRI contra-indications. * Steroid treatment less than one month (be taken orally or by infusion) at the dosage of 500mg daily. * Controls: * Known chronic psychiatric or neurologic diseases which could interfere with neuropsychological testing, not taking into account stable and mild depressive syndrome * Known chronic systemic diseases as judged by the investigator (for instance: lupus, Gougerot-Sjögren, sarcoidosis, scleroderma, Crohn disease…). * MS familial history * Current dependence on alcohol or drugs * Known cognitive impairment * Prior neuropsychological testing with the same tests less than one year * Dosage change, stop or start of hypnotic or anxiolytic or antidepressive treatment less than 2 months * Steroid treatment less than one month (be taken orally or by infusion) at the dosage of 500mg daily. * MRI contra-indications * Steroid treatment less than one month (be taken orally or by infusion) at the dosage of 500mg daily.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Clinically isolated demyelinating syndromes (CIS) can evolve into multiple sclerosis (MS). Cognitive deficiencies could occur at this early stage and concern mainly information processing speed (IPS) and their mechanisms are not fully understood. Diffusion Tensor Imaging (DTI) can help in the understanding of these mechanisms.
Papers
Loading reviews and guidelines…
History
Started
Aug 2012
Main results due
Dec 2016
Finished
Dec 2016