跳至主要内容
临床试验/NCT05385601
NCT05385601已完成不适用

Eye Movements Recording Using a Smartphone: Comparison to Standard Video-oculography and Correlation to Imaging Data in Young Athletes

Association de Recherche Bibliographique pour les Neurosciences1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2022年5月17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
36
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 smartphones or tablets, to record eye movements) with measurements from the standard video-oculography device (Eye-Tracker®T2), in young athletes. This study also aims to correlate these measurements with volumetric data from cerebral imaging (if MRI done in routine care at the same period, more or less 1 month).

详细描述

e-VOG Young athletes is a collaborative study between the Memory Center of the Rainier III Center (Princess Grace Hospital, Monaco), the Neurology Department of Nice University Hospital (France), and the AS Monaco Football Academy medical team.

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

e-VOG is a mobile application, home-developed by the Neurology Department team of Nice University Hospital, to measure eye movements.

In the continuity of the e-VOG(YA) study (NCT05211752), we set-up study named e-VOG-Young Athletes-Extension. This study will increase the number of assessments carried out (standard video-oculography assessment versus e-VOG digital assessment) in a population of athletes without major health problems, and who have not presented concussion, in order to meet more powerfully the main objective of the e-VOG(YA) study. It will also make it possible to observe whether there is a correlation between disturbed oculomotor movements, oculomotor anomalies and volumetric data measured by cerebral MRI (obtained using automatic segmentation software on cerebral regions specifically involved in the eye movement control).

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
15 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Young Athletes from AS Monaco Academy
  • referred by AS Monaco Medical Team to perform a video-oculography (Eye-Tracking) examination as part of routine care.
  • covered by a health insurance system
  • volunteer, able to give free, informed and written consent.

排除标准

  • General anaesthesia within 3 months.
  • Head trauma 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 according to the number of oculomotor abnormality observed (based on identified parameters assessments: latency / speed / gain / altered ocular pursuits / fixation disorders / presence of internuclear ophthalmoplegia), in accordance with the literature standards

次要结局

  • Impairment of horizontal smooth pursuit(Day 0)
  • Velocity during horizontal reflex saccades(Day 0)
  • Inhibition capacity(Day 0)
  • Impairment of vertical smooth pursuit(Day 0)
  • Imaging data correlation: Frontal Lobe Volume(Day 0)
  • Imaging data correlation: cerebellar volume(Day 0)
  • Latency during horizontal reflex saccades(Day 0)
  • Latency during vertical reflex saccades(Day 0)
  • Latency during horizontal voluntary saccades(Day 0)
  • Velocity during vertical reflex saccades(Day 0)
  • Internuclear ophthalmoplegia (INO) detection(Day 0)
  • Fixations impairments detection(Day 0)
  • Imaging data correlation: Total brain volume(Day 0)
  • Imaging data correlation: Parietal Lobe Volume(Day 0)
  • Imaging data correlation: Volume of additional motor areas(Day 0)
  • Imaging data correlation: Basal ganglia volume(Day 0)
  • Imaging data correlation: Total thalamic volume(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

Eye Movements Recording Using a Smartphone:... | 临床试验