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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)

Primary Purpose

Clinically Isolated Demyelinating Syndromes, Multiple Sclerosis, Cognitive Deficiencies

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Brain MRI - Clinical and cognitive evaluation

Eye movement

About this trial

This is an interventional diagnostic trial for Clinically Isolated Demyelinating Syndromes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

CHU de Bordeaux

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Patient

Control

Arm Description

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

healthy subject

Outcomes

Primary Outcome Measures

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

IPS, attention, working memory, episodic memory and executive functions), established by voxel-wise statistics (TBSS) in CIS patients

Secondary Outcome Measures

Comparison of skeleton of FA between CIS patients and healthy subjects

Comparison of cognitive scores at each test between CIS patients and controls

Proportion of patients with cognitive impairment (≥ 3 tests impaired) and correlations with anxiety, depressive syndrome and fatigue

Comparison of statistical maps of FA

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

Comparison of cognitive scores at each test and eye movements scores

Full Information

NCT ID

NCT01865357

First Posted

May 24, 2013

Last Updated

October 1, 2018

Sponsor

University Hospital, Bordeaux

Collaborators

TEVA laboratories

1. Study Identification

Unique Protocol Identification Number

NCT01865357

Brief 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

Acronym

SCI-COG

Official Title

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

August 24, 2012 (Actual)

Primary Completion Date

December 1, 2016 (Actual)

Study Completion Date

December 1, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Bordeaux

Collaborators

TEVA laboratories

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Clinically Isolated Demyelinating Syndromes, Multiple Sclerosis, Cognitive Deficiencies, Brain MRI

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

117 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Patient

Arm Type

Experimental

Arm Description

Arm Title

Control

Arm Type

Experimental

Arm Description

healthy subject

Intervention Type

Other

Intervention Name(s)

Brain MRI - Clinical and cognitive evaluation

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Eye movement

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

IPS, attention, working memory, episodic memory and executive functions), established by voxel-wise statistics (TBSS) in CIS patients

Time Frame

visit 2 - 1 year after inclusion

Secondary Outcome Measure Information:

Title

Comparison of skeleton of FA between CIS patients and healthy subjects

Time Frame

V2 - 1 year after the inclusion

Title

Comparison of cognitive scores at each test between CIS patients and controls

Time Frame