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

NCT03636789 | Completed

• 1 other identifier: NIMAO/2017-01/GC-01
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Radiologically Isolated Syndrome (RIS); Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Evaluation of the occurrence of oculomotor disorders

  using a video-oculographic recording system

  Day 0

Secondary Outcomes (3)

• To establish the prevalence of each of the different types of oculomotor abnormalities that constitute the oculomotor disorder

  Day 0

• To identify a correlation between oculomotor disorders and MRI abnormalities.

  Day 0

• To identify a correlation between oculomotor disorders and the cognitive impairment test (Symbol Digit Modalities Test)

  Day 0

Study Arms (1)

Neurological consultation group

EXPERIMENTAL

Other: Neurological consultation

Interventions

Neurological consultation OTHER

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

Neurological consultation group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• The subject participates in another 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (6)

Hôpital Neurologique Pierre Wertheimer

Bron, France

Location

Hôpital Guy de Chauliac

Montpellier, France

Location

Nice University Hospital

Nice, France

Location

Nimes University Hospital

Nîmes, France

Location

Pitié Salpêtrière University Hospital (APHP)

Paris, France

Location

Toulouse University Hospital

Toulouse, France

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Giovanni Castelnovo

  Nîmes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2018
• First Posted: August 17, 2018
• Study Start: October 26, 2018
• Primary Completion: October 21, 2021
• Study Completion: November 5, 2021
• Last Updated: April 18, 2022

Record last verified: 2022-04

Locations

FR (6)