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