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

Not Applicable

Completed

• Conditions: Multiple Sclerosis; Brain MRI; Clinically Isolated Demyelinating Syndromes; Cognitive Deficiencies
• Interventions: Other: Brain MRI - Clinical and cognitive evaluation; Other: Eye movement

• Registration Number: NCT01865357
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2012-08-24
• Study First Submitted: 2013-05-24
• Study First Submitted QC: 2013-05-24
• Study First Posted: 2013-05-30
• Primary Completion: 2016-12-01
• Study Completion: 2016-12-01
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-01
• Last Update Posted: 2018-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 117

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient	Brain MRI - Clinical and cognitive evaluation	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
Control	Eye movement	healthy subject
Control	Brain MRI - Clinical and cognitive evaluation	healthy subject
Patient	Eye movement	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

Primary Outcome Measures

Name	Time	Method
Correlation between fractional anisotropy (FA) value and cognitive z scores or cognitive impairment indexes for each domains	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

Name	Time	Method
Comparison of cognitive scores at each test between CIS patients and controls	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	D0 and V2 - 1 year after the inclusion
Comparison of skeleton of FA between CIS patients and healthy subjects	V2 - 1 year after the inclusion
Comparison of statistical maps of FA	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	D0 and V2 - 1 year after the inclusion
Comparison of cognitive scores at each test and eye movements scores	D0 and V2 - 1 year after the inclusion

Trial Locations

Locations (1)

CHU de Bordeaux; 🇫🇷 Bordeaux, France