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

Primary Purpose

Radiologically Isolated Syndrome (RIS), Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Neurological consultation
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Radiologically Isolated Syndrome (RIS)

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Neurologique Pierre Wertheimer
  • Hôpital Guy de Chauliac
  • Nice University Hospital
  • Nimes University Hospital
  • Pitié Salpêtrière University Hospital (APHP)
  • Toulouse University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Neurological consultation group

Arm Description

Outcomes

Primary Outcome Measures

Evaluation of the occurrence of oculomotor disorders
using a video-oculographic recording system

Secondary Outcome Measures

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

Full Information

First Posted
August 16, 2018
Last Updated
April 15, 2022
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT03636789
Brief Title
Evaluation of the Prevalence of Oculomotor Disorders in Patients With Radiologically Isolated Syndrome
Acronym
OCRIS
Official Title
Evaluation of the Prevalence of Oculomotor Disorders in Patients With Radiologically Isolated Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
October 26, 2018 (Actual)
Primary Completion Date
October 21, 2021 (Actual)
Study Completion Date
November 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiologically Isolated Syndrome (RIS), Multiple Sclerosis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neurological consultation group
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Neurological consultation
Intervention Description
study of horizontal, vertical, reflex and voluntary saccades, and of horizontal and vertical ocular pursuit by a BrainTracker eye-oculography system
Primary Outcome Measure Information:
Title
Evaluation of the occurrence of oculomotor disorders
Description
using a video-oculographic recording system
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
To establish the prevalence of each of the different types of oculomotor abnormalities that constitute the oculomotor disorder
Description
number
Time Frame
Day 0
Title
To identify a correlation between oculomotor disorders and MRI abnormalities.
Time Frame
Day 0
Title
To identify a correlation between oculomotor disorders and the cognitive impairment test (Symbol Digit Modalities Test)
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giovanni Castelnovo
Organizational Affiliation
Nîmes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Neurologique Pierre Wertheimer
City
Bron
Country
France
Facility Name
Hôpital Guy de Chauliac
City
Montpellier
Country
France
Facility Name
Nice University Hospital
City
Nice
Country
France
Facility Name
Nimes University Hospital
City
Nîmes
Country
France
Facility Name
Pitié Salpêtrière University Hospital (APHP)
City
Paris
Country
France
Facility Name
Toulouse University Hospital
City
Toulouse
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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