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

NCT ID: NCT01865357

Last Updated: 2018-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 117 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-24
• Study Completion Date: 2016-12-01

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Brain MRI - Clinical and cognitive evaluation

Intervention Type: 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

Intervention Type: OTHER

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

Control

healthy subject

Group Type: EXPERIMENTAL

Brain MRI - Clinical and cognitive evaluation

Intervention Type: 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

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eye movement

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

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

TEVA laboratories

UNKNOWN

Sponsor Role: collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bruno BROCHET, Prof

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

CHU de Bordeaux

Bordeaux, , France

Countries

France

References

Moroso A, Ruet A, Lamargue-Hamel D, Munsch F, Deloire M, Coupe 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.

Reference Type: DERIVED

PMID: 27789541 (View on PubMed)

Other Identifiers

CHUBX 2011/33

Identifier Type: -

Identifier Source: org_study_id