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Completed

NCT Number: 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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Bordeaux

Bordeaux, 33000, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Brain MRI - Clinical and cognitive evaluation

Other
  • 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

Other

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Collaborators

  • TEVA laboratories

Registry information

Official study 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

Acronym: SCI-COG

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
May 30, 2013
Registry last updated
Oct 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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