A Cross-Sectional Study to Evaluate the Correlation Between Oculometric Measures and MDS-UPDRS in Patients With Idiopathic Parkinson's Disease (PD) and Evaluation of Oculometric Measures in Healthy Participants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- NeuraLight
- 入组人数
- 465
- 试验地点
- 2
- 主要终点
- Correlation between MDS-UPDRS score and its parts with NeuraLight oculometric measurements
研究概览
简要总结
This is a prospective study in a cohort of about 500 patients with Idiopathic Parkinson's disease, examined routinely in the neurological outpatient clinic.
This study aims to evaluate the correlation between oculometric measures and clinical endpoints. Subjects will be evaluated following a physician examination.The evaluations will include MDS-UPDRS examination, as well as an oculometric evaluation for eye movements. In addition, 500 healthy subjects will be evaluated.
详细描述
This is a prospective study in a cohort of patients with idiopathic PD who are visiting the Parkinson's outpatient clinic. The aim of the study is to evaluate the correlation between oculometric measures and MDS-UPDRS score in subjects who meet the inclusion criteria and who provide a signed Informed Consent.
This study is designed to evaluate the correlation between oculometric measures and the Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS). Subjects will be evaluated at their visit to the clinic. The evaluations will include an MDS-UPDRS examination by a certified neurologist and other tests. In addition, all patients will undergo a NeuraLight session for oculometric evaluation along with eye-tracking recordings. All assessments will be performed during a clinic visit unless authorized to be conducted remotely. In addition, 500 healthy subjects will be evaluated, undergoing a NeuraLight session for oculometric evaluation along with eye-tracking recordings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- 是
入选标准
- •PD patients:
- •Inclusion Criteria:
- •Men and women with idiopathic PD (Hoehn & Yahr scale 1-5)
- •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 20 minutes on a chair in a calm manner
- •Personal or 1st degree relative history of epilepsy
- •Additional neurological diseases
- •Drug or alcohol abuse
- •Healthy subjects:
- •Inclusion Criteria:
- •Age between 18 and 85 years old
- •Normal or corrected vision
- •Ability to follow instructions
- •Willing and able to sign an informed consent form
- •Exclusion Criteria
- •Inability to sit for 20 minutes on a chair in a calm manner
- •Personal or 1st degree relative history of epilepsy
- •Neurological diseases
- •Drug or alcohol abuse
研究组 & 干预措施
PD patients visiting clinic
All patients will undergo a NeuraLight session for oculometric evaluation along with eye-tracking recordings. All assessments will be performed during a clinic visit unless authorized to be conducted remotely.
干预措施: NeuraLight software-based platform (Other)
Healthy subjects
All patients will undergo a NeuraLight session for oculometric evaluation along with eye-tracking recordings. All assessments will be performed during a visit unless authorized to be conducted remotely.
干预措施: NeuraLight software-based platform (Other)
结局指标
主要结局
Correlation between MDS-UPDRS score and its parts with NeuraLight oculometric measurements
时间窗: 12 months
The correlation between MDS-UPDRS score and its parts with NeuraLight oculometric measurements (R-Square\>0.5, p\<0.05) according to the Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) at every visit
Comparison of NeuraLight extracted oculometric measures with a validated eye-tracking system
时间窗: 12 months
Relative root mean square error (RMSE) of NeuraLight's extracted oculometric measures compared with retrieved measurements from a validated eye tracking system \<0.1
Feasibility of using NeuraLight system to capture oculometric measures in a cohort of PD patients and healthy subjects
时间窗: 12 months
Capturing \>50 different oculometric measures in \>95% of a cohort of about 1000 patients
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)