Overview

This trial is active, not recruiting.

Conditions clinically isolated demyelinating syndromes, multiple sclerosis, cognitive deficiencies, brain mri
Treatments brain mri - clinical and cognitive evaluation, eye movement
Sponsor University Hospital, Bordeaux
Collaborator TEVA laboratories
Start date August 2012
End date December 2016
Trial size 120 participants
Trial identifier NCT01865357, CHUBX 2011/33

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
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
brain mri - clinical and cognitive evaluation
Clinical evaluation (EDSS, MSFC) Cognitive evaluation with tests of information processing speed, attention, working memory, episodic memory and executive functions, assessment of confounding factors (depression (BDI) and anxiety (HAD), mood (EHD), fatigue (M-FIS) and assessment of quality of life (SEP-59) Brain MRI (3 Tesla): FLAIR, 3D MPRAGE T1 and DTI
eye movement
Assessment of eye Movements (EyeBrain software) for only the group of 15 healthy subjects at baseline and at 12 months
(Experimental)
healthy subject
brain mri - clinical and cognitive evaluation
Clinical evaluation (EDSS, MSFC) Cognitive evaluation with tests of information processing speed, attention, working memory, episodic memory and executive functions, assessment of confounding factors (depression (BDI) and anxiety (HAD), mood (EHD), fatigue (M-FIS) and assessment of quality of life (SEP-59) Brain MRI (3 Tesla): FLAIR, 3D MPRAGE T1 and DTI
eye movement
Assessment of eye Movements (EyeBrain software) for only the group of 15 healthy subjects at baseline and at 12 months

Primary Outcomes

Measure
Correlation between fractional anisotropy (FA) value and cognitive z scores or cognitive impairment indexes for each domains
time frame: visit 2 - 1 year after inclusion

Secondary Outcomes

Measure
Comparison of skeleton of FA between CIS patients and healthy subjects
time frame: V2 - 1 year after the inclusion
Comparison of cognitive scores at each test between CIS patients and controls
time frame: D0 and V2 - 1 year after the inclusion
Proportion of patients with cognitive impairment (≥ 3 tests impaired) and correlations with anxiety, depressive syndrome and fatigue
time frame: D0 and V2 - 1 year after the inclusion
Comparison of statistical maps of FA
time frame: D0 and V2 - 1 year after the inclusion
Correlations between cognitive scores and mean cortical thickness and deep grey nuclei volumes in CIS patients
time frame: D0 and V2 - 1 year after the inclusion
Comparison of cognitive scores at each test and eye movements scores
time frame: D0 and V2 - 1 year after the inclusion

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

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
Principal investigator Bruno BROCHET, Prof
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by University Hospital, Bordeaux.