Using Mathematical Quantification of Limb and Eye Movements of Parkinson's Disease Patients As a Biomarker for Classification and Prediction of Disease State and Response to Treatment
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Quantification of current IPD motor symptoms using kinetic tremor and Dyskinesia test
研究概览
简要总结
This is a three-armed open investigational study that aims to differentiate, quantify, and categorize abnormal eye movements and upper limbs movements in patients with Parkinson's disease. The study is using investigational non-invasive devices for that reason including ANLIVA® Hand Movement and ANLIVA® Eye Movement.
详细描述
To evaluate performance of mathematical models developed to quantify and classify symptoms and disease state using sensor data from smart phone and eye tracking cameras in subjects with Parkinson's disease.
A clinical investigator will be capturing data from the clinical encounter completed by default the same day in addition to other clinical questionnaires subjects will be filling themselves. A percentage of subjects will be asked prior to their arrival to be part of a subset study called OFF/ON study, where they will be asked not to take their IPD oral home medications prior to arrival. Both study procedure elements will be performed at the beginning of the evaluation and 60 minutes after taking their medication. There is also a longitudinal study part, where a percentage of the subjects will be asked to visit the clinic with 6 months interval, up to 4 times, including the first visit. There will be a percentage of approached subjects that belong to the category of Essential Tremor (ET) and Healthy control (HC) used for comparison purposes. ET and HC subjects will undergo the same recruitment and testing process.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For inclusion in the investigation, the subjects must fulfil all the below criteria prior to enrolment:
- •Subjects already diagnosed with Idiopathic Parkinson's Disease (IPD)
- •or subjects already diagnosed with Essential tremor (ET)
- •or subjects who are healthy controls (HC) and are not diagnosed with IPD or ET
- •Able to understand and sign the informed consent form.
排除标准
- •Subjects that meet any of the below criteria will be excluded:
- •Not able to sign the informed consent form
- •Below 18 years of age
- •Diagnosed with movement disorder other than IPD or ET that might interfere with hand movements or eye movements (tics, myoclonus, chorea, dystonia, etc)
- •Has parkinsonism not due to IPD (drug induced, functional, vascular, etc)
- •Visual or physical limitations that prevent the subject from performing the baseline eye study requirements
- •Being involved in the planning and conduct of the clinical investigation (applies to all sponsor management staff, investigational staff and third-party vendors as applicable)
研究组 & 干预措施
ON, One visit
Subject visit one time at clinic for tests and assessments. Subject type are Essential Tremor (ET), Healthy Control (HC) or Idiopathic Parkinson's Disease (IPD).
The first arm will include the majority of subjects that will be enrolled in a onetime only study procedure performance. Subjects of this arm will carry the diagnosis of IPD, ET, or HC. After the completion of their first research visit and completing study procedures, there will be no future visits or procedures.
干预措施: Evaluation of mathematical models (Device)
OFF/ON
Subject visit one time at clinic for tests and assessments without medication, carry out tests and assessments, then take medication according to the protocol, then carry our tests and assessments.
Subject type are Idiopathic Parkinson's Disease.
干预措施: 150% of their routine home dopaminergic medications dose right in the clinic (Drug)
OFF/ON
Subject visit one time at clinic for tests and assessments without medication, carry out tests and assessments, then take medication according to the protocol, then carry our tests and assessments.
Subject type are Idiopathic Parkinson's Disease.
干预措施: Evaluation of mathematical models (Device)
ON, Longitudinal
IPD subjects will be asked to repeat the study visit and procedures every 6 months for longitudinal monitoring.
干预措施: Evaluation of mathematical models (Device)
结局指标
主要结局
Quantification of current IPD motor symptoms using kinetic tremor and Dyskinesia test
时间窗: Day 1
ANLIVA® Hand Movement score of kinetic tremor test and dyskinesia test will be measured. Measurements are done on subjects upper limb movements. SD score of kinetic tremor test and dyskinesia test will be assessed by assessors. SD is acronym for Stardots-Dartmouth score. The SD score will be used to benchmark the ANLIVA® device assessments as a nonreference standard. Minimum value is 0; maximum value is 4. A higher value on the SD score means more movement disorder.
次要结局
- Quantification of current IPD motor symptoms using rest tremor and postural tremor test(Day 1)
- Classification between Dyskinesia or kinetic tremor(Day 1)