Clinical trial NCT01865357: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Clinically Isolated Demyelinating Syndromes
Multiple Sclerosis
Cognitive Deficiencies
Brain MRI
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: TEVA laboratories
First posted: 2013-05-30
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: This is a prospective cohort, observational, longitudinal, monocentric study. This study will include 60 patients with CIS followed for 1 year and 60 healthy subjects.

Eligibility 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.

Primary outcomes:
measure: Correlation between fractional anisotropy (FA) value and cognitive z scores or cognitive impairment indexes for each domains
timeFrame: visit 2 - 1 year after inclusion
Secondary outcomes:
measure: Comparison of skeleton of FA between CIS patients and healthy subjects
timeFrame: V2 - 1 year after the inclusion
measure: Comparison of cognitive scores at each test between CIS patients and controls
timeFrame: D0 and V2 - 1 year after the inclusion
measure: Proportion of patients with cognitive impairment (≥ 3 tests impaired) and correlations with anxiety, depressive syndrome and fatigue
timeFrame: D0 and V2 - 1 year after the inclusion
measure: Comparison of statistical maps of FA
timeFrame: D0 and V2 - 1 year after the inclusion
measure: Correlations between cognitive scores and mean cortical thickness and deep grey nuclei volumes in CIS patients
timeFrame: D0 and V2 - 1 year after the inclusion
measure: Comparison of cognitive scores at each test and eye movements scores
timeFrame: D0 and V2 - 1 year after the inclusion
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
Study officials:
affiliation: University Hospital, Bordeaux
name: Bruno BROCHET, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moroso A, Ruet A, Lamargue-Hamel D, Munsch F, Deloire M, Coupe P, Ouallet JC, Planche V, Moscufo N, Meier DS, Tourdias T, Guttmann CR, Dousset V, Brochet B. Posterior lobules of the cerebellum and information processing speed at various stages of multiple sclerosis. J Neurol Neurosurg Psychiatry. 2017 Feb;88(2):146-151. doi: 10.1136/jnnp-2016-313867. Epub 2016 Oct 27.