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

NCT ID: NCT03636789

Last Updated: 2022-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-26

Study Completion Date

2021-11-05

Brief Summary

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

Detailed Description

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Conditions

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Radiologically Isolated Syndrome (RIS) Multiple Sclerosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Neurological consultation group

Group Type EXPERIMENTAL

Neurological consultation

Intervention Type OTHER

study of horizontal, vertical, reflex and voluntary saccades, and of horizontal and vertical ocular pursuit by a BrainTracker eye-oculography system

Interventions

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Neurological consultation

study of horizontal, vertical, reflex and voluntary saccades, and of horizontal and vertical ocular pursuit by a BrainTracker eye-oculography system

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Giovanni Castelnovo

Role: PRINCIPAL_INVESTIGATOR

Nîmes University Hospital

Locations

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Hôpital Neurologique Pierre Wertheimer

Bron, , France

Site Status

Hôpital Guy de Chauliac

Montpellier, , France

Site Status

Nice University Hospital

Nice, , France

Site Status

Nimes University Hospital

Nîmes, , France

Site Status

Pitié Salpêtrière University Hospital (APHP)

Paris, , France

Site Status

Toulouse University Hospital

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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NIMAO/2017-01/GC-01

Identifier Type: -

Identifier Source: org_study_id

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