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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

Tracking Information
First Submitted Date  ICMJE May 24, 2013
First Posted Date  ICMJE May 30, 2013
Last Update Posted Date October 3, 2018
Actual Study Start Date  ICMJE August 24, 2012
Actual Primary Completion Date December 1, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 24, 2013)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01865357 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2014)
  • 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 ]
    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.
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2013)
  • 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 ]
    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.
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Clinically Isolated Demyelinating Syndromes
  • Multiple Sclerosis
  • Cognitive Deficiencies
  • Brain MRI
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
    Interventions:
    • Other: Brain MRI - Clinical and cognitive evaluation
    • Other: Eye movement
  • Experimental: Control
    healthy subject
    Interventions:
    • Other: Brain MRI - Clinical and cognitive evaluation
    • Other: Eye movement
Publications * Moroso A, Ruet A, Lamargue-Hamel D, Munsch F, Deloire M, Coupé 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 1, 2018)
117
Original Estimated Enrollment  ICMJE
 (submitted: May 24, 2013)
120
Actual Study Completion Date  ICMJE December 1, 2016
Actual Primary Completion Date December 1, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01865357
Other Study ID Numbers  ICMJE CHUBX 2011/33
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Bordeaux
Study Sponsor  ICMJE University Hospital, Bordeaux
Collaborators  ICMJE TEVA laboratories
Investigators  ICMJE
Principal Investigator: Bruno BROCHET, Prof CHU - Bordeaux
PRS Account University Hospital, Bordeaux
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP