跳至主要内容
临床试验/NCT04702763
NCT04702763已完成不适用

Eye Movements Recording Using a Smartphone: Comparison to Standard Video-oculography Data in Patients With Multiple Sclerosis

Association de Recherche Bibliographique pour les Neurosciences1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年10月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Oculomotor profiles concordance

研究概览

简要总结

This study aims to compare measurements obtained through the e-VOG application (mobile application, usable on mobile phones or tablets, to measure eye movements) with measurements from the standard video-oculography device (Eye-Tracker®T2), in patient with Multiple Sclerosis.

详细描述

Based on literature, investigators hypothesize that it would be relevant to focus more broadly on subclinical abnormalities of oculomotricity in multiple sclerosis (MS). However, the difficulty of accessing video-oculography platforms (or eye-tracking devices) is probably one of the main limitations to performing this type of assessment.

To respond this problem, the "Resources and Skills Center-Multiple Sclerosis" (CRC SEP) team at the Nice University Hospital Center (France) has developed a mobile application (named e-VOG), usable on mobile phones or tablets, to measure eye movements. e-VOG reproduces the classic paradigms of video-oculography to collect data similar to standard video-oculography recording (saccade latency and speed, anti-saccade error rate, presence of fixation abnormalities).

e-VOG will not replace standard video-oculography platforms, because its technical characteristics are not as high. But investigators hypothesize that this application could constitute a screening tool for subclinical oculomotor abnormalities, usable by neurologists in consultation, directly on their mobile, which would make it possible to select a smaller population of patients in whom a further exploration by standard video-oculography would be indicated.

Memory Center of the Rainier III Gerontologic Center (Princess Grace Hospital - Monaco) is equipped with a standard video-oculography device, also named eye-tracking device (Eye-Tracker®T2), which records eye movements at a high frequency and measures saccades parameters (latency, speed, amplitudes etc...).

This study is a collaborative study between the Center Rainier III team and the CRC SEP team in Nice. Its objective will be to compare measurements obtained through the e-VOG application with measurements from the standard video-oculography device.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or Female.
  • 18 years old and above.
  • referred by a neurologist to perform a video-oculography (Eye-Tracking) examination as part of routine care.
  • with Multiple Sclerosis (defined according to McDonald's 2017 criteria).
  • covered by a health insurance system
  • volunteer, able to give free, informed and written consent.

排除标准

  • General anaesthesia within 3 months.
  • Neurological, ophthalmological or general pathology preventing the realization of a video-oculography examination.
  • Oculomotor abnormality detectable on clinical examination by the neurologist prescribing the standard video-oculography examination.

结局指标

主要结局

Oculomotor profiles concordance

时间窗: Day 0

Analyze of the concordance of the profiles obtained between the e-VOG digital assessment and the standard video-oculography assessment. Evaluation criteria: For each assessment, patients will be classified into 3 profiles (Profile 1 = profile without oculomotor abnormality; Profile 2 = intermediate profile with 1 to 2 oculomotor abnormalities; Profile 3: profile with 3 to 4 oculomotor anomalies), based on the observation of 4 parameters (latency / speed / fixation disorders / presence of internuclear ophthalmoplegia), in accordance with the literature standards.

次要结局

  • Latency during horizontal reflex saccades(Day 0)
  • Velocity during horizontal reflex saccades(Day 0)
  • Internuclear ophthalmoplegia (INO) detection(Day 0)
  • Patient acceptability of the e-VOG digital assessment(Day 0)
  • Latency during vertical reflex saccades(Day 0)
  • Inhibition capacity(Day 0)
  • Velocity during vertical reflex saccades(Day 0)
  • Impairment of horizontal smooth pursuit(Day 0)
  • Fixations impairments detection(Day 0)
  • Impairment of vertical smooth pursuit(Day 0)

研究者

发起方
Association de Recherche Bibliographique pour les Neurosciences
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验