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Completed

NCT Number: NCT03636789

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

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

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Key information

Conditions

Radiologically Isolated Syndrome (RIS) Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Nervous System Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Neurologique Pierre Wertheimer, Bron, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neurological consultation

Other

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

Primary outcomes

  1. Evaluation of the occurrence of oculomotor disorders

    Time frame: Day 0

    using a video-oculographic recording system

Secondary outcomes

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

    Time frame: Day 0

    number

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

    Time frame: Day 0

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

    Time frame: Day 0

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: OCRIS

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Aug 17, 2018
Registry last updated
Apr 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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