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

Multiple Sclerosis Clinical Trial

— OCRIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03636789
• Other study ID #: NIMAO/2017-01/GC-01
• Status: Completed
• Phase: N/A
• Start date: October 26, 2018
• Est. completion date: November 5, 2021

Study information

• Verified date: April 2022
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: November 5, 2021
• Est. primary completion date: October 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Radiologically Isolated Syndrome (RIS)
• Syndrome

Intervention

Other:
• Neurological consultation
study of horizontal, vertical, reflex and voluntary saccades, and of horizontal and vertical ocular pursuit by a BrainTracker eye-oculography system

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the occurrence of oculomotor disorders	using a video-oculographic recording system	Day 0
Secondary	To establish the prevalence of each of the different types of oculomotor abnormalities that constitute the oculomotor disorder	number	Day 0
Secondary	To identify a correlation between oculomotor disorders and MRI abnormalities.		Day 0
Secondary	To identify a correlation between oculomotor disorders and the cognitive impairment test (Symbol Digit Modalities Test)		Day 0