Evaluation of the Prevalence of Oculomotor Disorders in Patients With Radiologically Isolated Syndrome

Not Applicable

Completed

• Conditions: Radiologically Isolated Syndrome (RIS); Multiple Sclerosis

• Registration Number: NCT03636789
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

This study aims to investigate the prevalence of subclinical oculomotor disorders in a population of patients with radiologically isolated syndrome.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-16
• Study First Submitted QC: 2018-08-16
• Study First Posted: 2018-08-17
• Study Start: 2018-10-26
• Primary Completion: 2021-10-21
• Study Completion: 2021-11-05
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-15
• Last Update Posted: 2022-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

• The patient must have given his informed consent and signed the consent form.
• The patient must be affiliated or beneficiary of a health insurance plan.
• The patient is at least 18 years old (≥) and under 50 years old (≤).
• Patients with radiologically isolated syndrome according to the criteria of Okuda et al. (2009)
• Diagnosis of a radiologically isolated syndrome confirmed by the national expert center of Nice for less than 3 years.

Exclusion Criteria

• The subject participates in another study.
• The subject is in an exclusion period determined by a previous study.
• The subject is under guardianship, curatorship or safeguard of justice.
• The patient is pregnant or breastfeeding
• The subject refuses to sign the consent.
• It is not possible to give the subject informed information.
• Patient presenting a pathological neurological examination.
• Patient with visual acuity less than 5/10 or with ocular instability

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Evaluation of the occurrence of oculomotor disorders	Day 0	using a video-oculographic recording system

Secondary Outcome Measures

Name	Time	Method
To identify a correlation between oculomotor disorders and the cognitive impairment test (Symbol Digit Modalities Test)	Day 0
To identify a correlation between oculomotor disorders and MRI abnormalities.	Day 0
To establish the prevalence of each of the different types of oculomotor abnormalities that constitute the oculomotor disorder	Day 0	number

Trial Locations

Locations (6)

Hôpital Neurologique Pierre Wertheimer; 🇫🇷 Bron, France

Hôpital Guy de Chauliac; 🇫🇷 Montpellier, France

Nice University Hospital; 🇫🇷 Nice, France

Nimes University Hospital; 🇫🇷 Nîmes, France

Pitié Salpêtrière University Hospital (APHP); 🇫🇷 Paris, France

Toulouse University Hospital; 🇫🇷 Toulouse, France