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

NCT01865357 | Completed

• 1 other identifier: CHUBX 2011/33
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

  visit 2 - 1 year after inclusion

Secondary Outcomes (6)

• Comparison of skeleton of FA between CIS patients and healthy subjects

  V2 - 1 year after the inclusion

• 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 statistical maps of FA

  D0 and V2 - 1 year after the inclusion

• Correlations between cognitive scores and mean cortical thickness and deep grey nuclei volumes in CIS patients

  D0 and V2 - 1 year after the inclusion

Study Arms (2)

Patient

EXPERIMENTAL

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

Other: Brain MRI - Clinical and cognitive evaluation; Other: Eye movement

Control

EXPERIMENTAL

healthy subject

Other: Brain MRI - Clinical and cognitive evaluation; Other: Eye movement

Interventions

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

Control; Patient

Eye movement OTHER

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

Control; Patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• TEVA laboratories: collaborator

Study Sites (1)

CHU de Bordeaux

Bordeaux, 33000, France

Location

Related Publications (1)

• 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.

  PMID: 27789541 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Eye Movements

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Ocular Physiological Phenomena

Study Officials

• Bruno BROCHET, Prof

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2013
• First Posted: May 30, 2013
• Study Start: August 24, 2012
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: October 3, 2018

Record last verified: 2018-10

Locations

FR (1)