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

Multiple Sclerosis Clinical Trial

— SCI-COG  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01865357
• Other study ID #: CHUBX 2011/33
• Status: Completed
• Phase: N/A
• Start date: August 24, 2012
• Est. completion date: December 1, 2016

Study information

• Verified date: October 2018
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: December 1, 2016
• Est. primary completion date: December 1, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain MRI
• Clinically Isolated Demyelinating Syndromes
• Cognitive Deficiencies
• Multiple Sclerosis
• Sclerosis
• Syndrome

Intervention

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

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	TEVA laboratories

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Comparison of skeleton of FA between CIS patients and healthy subjects		V2 - 1 year after the inclusion
Secondary	Comparison of cognitive scores at each test between CIS patients and controls		D0 and V2 - 1 year after the inclusion
Secondary	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
Secondary	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.	D0 and V2 - 1 year after the inclusion
Secondary	Correlations between cognitive scores and mean cortical thickness and deep grey nuclei volumes in CIS patients		D0 and V2 - 1 year after the inclusion
Secondary	Comparison of cognitive scores at each test and eye movements scores		D0 and V2 - 1 year after the inclusion