A Longitudinal Study to Evaluate the Correlation Between Oculometric Measures and MDS-UPDRS Over Time in a Cohort of Patients With Idiopathic Parkinson's Disease (PD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- NeuraLight
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change of anti-saccadic error rates over time as evaluated during visits
研究概览
简要总结
This is a prospective study in a cohort of about 30 patients with Idiopathic Parkinson's disease, who will be evaluated with a clinical assessment and an oculometric examination during a time period with specific intervals.
This study aims to evaluate the correlation between oculometric measures and clinical assessment over time.
详细描述
This is an observational prospective cohort study, in a cohort of up to 30 patients with idiopathic PD. The aim of this study is to demonstrate that oculometric measures are able to detect patient deterioration faster than can be detected using the currently available clinical assessment tools. In addition, to evaluate the correlation between oculometric measures and Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score over time ,in subjects who meet the inclusion and exclusion criteria, and who provide a signed Informed Consent. All patients will be assessed using MDS-UPDRS over a period of 9 months (4 assessments, at 0, 3, 6, 9 months). During this time period, every subject who consents will undergo a NeuraLight session including oculometric measurements and eye-tracking recordings using a novel software-based platform and an eye- tracking system (Tobii, CE-marked class B approved device) (approx. 30 minutes). The oculometric evaluation will occur during the first 3 months for every patient every 2 weeks (+3 days), and then after 6 months and 9 months from enrollment (+3 days), (9 tests in total). All assessments will be performed during a clinic visit unless authorized to be conducted remotely. During the study, the sponsor will be blinded to the private details of the subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women with idiopathic PD (Hoehn & Yahr scale 1-3)
- •Age between 18 and 85 years old
- •Normal or corrected vision
- •Ability to follow instructions
- •Willing and able to sign an informed consent form
排除标准
- •Inability to sit for 30 minutes on a chair in a calm manner
- •Personal or 1st degree relative history of epilepsy
- •Additional neurological diseases
- •Drug or alcohol abuse (except for using medical cannabis during 24 hours prior NL examination date)
- •Pregnancy or a potential pregnancy (self-declaration)
结局指标
主要结局
Change of anti-saccadic error rates over time as evaluated during visits
时间窗: 12 months
Difference between anti-saccadic error rates (%) as quantified during each visit by the NeuraLight test measured using a statistical comparison of values (e.g. t-test, ANOVA), p\>0.05) over time during study period
Correlation between MDS-UPDRS score and its parts with smooth pursuit
时间窗: 12 months
The correlation between MDS-UPDRS score and its parts with smooth pursuit speed (ms) measured using R-Square (high correlation\>0.5, moderate correlation 0.2-0.5, low correlation\<0.2), p\<0.05) according to the Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) at visits
Change of saccadic latency over time as evaluated during visits
时间窗: 12 months
Difference between saccadic latency (ms) as quantified during each visit by the NeuraLight test measured using a statistical comparison of values (e.g. t-test, ANOVA), p\>0.05) over time during study period
Change of smooth pursuit speed over time as evaluated during visits
时间窗: 12 months
Difference between smooth pursuit speed (ms)as quantified during each visit by the NeuraLight test measured using a statistical comparison of values (e.g. t-test, ANOVA), p\>0.05) over time during study period
Correlation between MDS-UPDRS score and its parts with saccadic latency
时间窗: 12 months
The correlation between MDS-UPDRS score and its parts with saccadic latency (ms) measured using R-Square (high correlation\>0.5, moderate correlation 0.2-0.5, low correlation\<0.2), p\<0.05) according to the Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) at visits
Correlation between MDS-UPDRS score and its parts with anti-saccadic error rates
时间窗: 12 months
The correlation between MDS-UPDRS score and its parts with anti-saccadic error rates (%), measured using R-Square (high correlation\>0.5, moderate correlation 0.2-0.5, low correlation\<0.2), p\<0.05) according to the Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) at visits
次要结局
- Using the retrieved data of collected NeuraLight oculometric measures for calibration of prediction models of MDS-UPDRS clinical endpoint(12 months)