Status:
COMPLETED
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
Lead Sponsor:
University Hospital, Bordeaux
Collaborating Sponsors:
TEVA laboratories
Conditions:
Clinically Isolated Demyelinating Syndromes
Multiple Sclerosis
Eligibility:
All Genders
18+ years
Phase:
NA
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) ...
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 24 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT01865357
Start Date
August 24 2012
End Date
December 1 2016
Last Update
October 3 2018
Active Locations (1)
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1
CHU de Bordeaux
Bordeaux, France, 33000