Longitudinal Study in Clinically Isolated Syndrome (CIS) Patients Treated With Interferon Beta (QUALICIS)
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The aim of this study is to evaluate the role of cognitive disorders and quality of life in patients with CIS, considered as high risk to develop an MS, treated with interferon Beta. This prospective observational study will include 120 patients, all treated and evaluated annually with neurological extensive examination, ophthalmologic screening (OCT, OF, VEP, VF), auto questionnaire about fatigue (musicol, ELIF), quality of life (SEP-59), and conventional MRI.
Clinical exams performed at Baseline and every year during 3 years Neurological examination: relapses recording and EDSS. Quality of life: SEP-59, MusiQOL. Neuropsychological screening [ Time Frame: 3 years ]
Secondary Outcome Measures :
Fatigue test: MS Fatigue, MRI (T1 gadolinium, T2, sagittale T1, acquisition volumique 3D T1), Optical coherence tomography (OCT) [ Time Frame: 3 years ]
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patient with CIS and temporo spatial dissemination for less than one year without prior immunomodulatory treatment
Patients older than 18 years,
Patients with CIS and temporo spatial dissemination for less than one year
Patient without prior immunomodulatory treatment
Patient informed of CIS diagnosis and MS according to McDonald criteria,
Patients with EDSS inferior or egal to 5,5
Patients usually french-reader and with MMS >24
Patients informed of study protocol
Patients agree to sign informed consent
Patients with affiliation number from social French département.
Secondary progressive MS
Patient with acute relapse
Patient already treated with IFN
corticosteroids less than 15 days
Patient with severe dépressive disorders
Patient already included in clinical study
Patient < 18 years
Patient with known contra indications for beta interféron
Every reason with can provoke an interruption of the study, regarding a patient empechment
Contre indications for MRI or other tests required in the study