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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)

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ClinicalTrials.gov Identifier: NCT01865357
Recruitment Status : Completed
First Posted : May 30, 2013
Last Update Posted : October 3, 2018
Sponsor:
Collaborator:
TEVA laboratories
Information provided by (Responsible Party):
University Hospital, Bordeaux

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.

Condition or disease Intervention/treatment Phase
Clinically Isolated Demyelinating Syndromes Multiple Sclerosis Cognitive Deficiencies Brain MRI Other: Brain MRI - Clinical and cognitive evaluation Other: Eye movement Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : August 24, 2012
Actual Primary Completion Date : December 1, 2016
Actual Study Completion Date : December 1, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patient
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
Other: 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

Other: Eye movement
Assessment of eye Movements (EyeBrain software) for only the group of 15 healthy subjects at baseline and at 12 months

Experimental: Control
healthy subject
Other: 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

Other: Eye movement
Assessment of eye Movements (EyeBrain software) for only the group of 15 healthy subjects at baseline and at 12 months




Primary Outcome Measures :
  1. 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 ]
    IPS, attention, working memory, episodic memory and executive functions), established by voxel-wise statistics (TBSS) in CIS patients


Secondary Outcome Measures :
  1. Comparison of skeleton of FA between CIS patients and healthy subjects [ Time Frame: V2 - 1 year after the inclusion ]
  2. Comparison of cognitive scores at each test between CIS patients and controls [ Time Frame: D0 and V2 - 1 year after the inclusion ]
  3. 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 ]
  4. Comparison of statistical maps of FA [ Time Frame: D0 and V2 - 1 year after the inclusion ]
    mean cortical thickness and deep grey nuclei volumes with cognitive indexes in the 3 pre-define groups: cognitively preserved CIS patients at baseline and after one year; cognitively impaired CIS patients only after one year and cognitively impaired CIS patients at the two evaluations.

  5. 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 ]
  6. Comparison of cognitive scores at each test and eye movements scores [ Time Frame: D0 and V2 - 1 year after the inclusion ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01865357


Locations
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France
CHU de Bordeaux
Bordeaux, France, 33000
Sponsors and Collaborators
University Hospital, Bordeaux
TEVA laboratories
Investigators
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Principal Investigator: Bruno BROCHET, Prof CHU - Bordeaux

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT01865357    
Other Study ID Numbers: CHUBX 2011/33
First Posted: May 30, 2013    Key Record Dates
Last Update Posted: October 3, 2018
Last Verified: October 2018
Additional relevant MeSH terms:
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Multiple Sclerosis
Syndrome
Sclerosis
Disease
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases