Oxford Study of Quantification in Parkinsonism Study - OXQUIP
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Saccadic eye movements
研究概览
简要总结
The OxQUIP (Oxford QUantification In Parkinsonism) study is recruiting patients with Parkinson's Disease and Progressive Supranuclear Palsy. Currently available treatments for these diseases are symptomatic only, and do not have any preventive or disease-slowing effect. As new drugs are developed, there is a need to be able to evaluate them quickly, so that precious time and resources can be devoted to those showing most promise.
This study follows participants intensively over an initially 3 year period, with the aim of identifying measures that can detect disease progression over much shorter time periods than is possible at present.
During the study participants are asked to perform simple tasks while the investigators measure movements of the eyes, hands and body. The investigators also do some tasks on a tablet computer that measure cognitive performance.
详细描述
Parkinson's disease (PD) is a common neurodegenerative disease that affects one in every hundred people over the age of 55. It is estimated that there are seven to ten million people with PD worldwide. It is disabling, incurable and gradually progressive. Progressive Supranuclear Palsy (PSP) is a related condition that presents initially with very similar features to PD. Eventually other features appear that are not part of idiopathic PD, such as paralysis of voluntary upgaze. Currently available treatments for both PD and PSP are symptomatic only, and while they may be effective for a number of years, they do not have any preventive or disease-slowing effect.
One of the problems with these conditions is that presently, there is a lack of completely reliable means of measuring their severity. The investigators use "clinical rating scales" which are points-based systems in which a doctor or nurse has to score how badly the person with PD or PSP is affected by various aspects of their condition. This is a subjective process, in other words it depends on the impression of the person making the assessment, and two doctors may sometimes disagree about the score. The scale is also sometimes difficult to interpret, for example the difference between scores of 20 and 30 may not be the same size as the difference between scores of 30 and 40. In contrast, most medical conditions nowadays can be very accurately and reliably measured using special equipment, for example the level of a patient's blood pressure, or the difficulty of breathing in asthma.
The need for accurate measures is particularly great when conducting trials of new drugs. Accurate evaluation of whether they work or not depends on precise measures of disease symptoms for each patient both before and after treatment. Drug trials may take years, and an accurate early measure of effect would allow interim results to guide decisions at which point resources can be focussed on those drugs that look most promising.
The aim of this study is to develop and validate sensitive tests to measure the symptoms of PD and PSP.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The participant may enter the study as a patient participant if ALL of the following apply:
- •Participant is willing and able to give informed consent for participation in the study
- •Fluent in English
- •Male or Female, aged 50 years or above
- •Patient diagnosed with PD or PSP by a specialist movement disorders neurologist, or age matched healthy control (often but not always the spouse of a patient)
- •No evidence of significant cognitive impairment
- •Normal or corrected-to-normal vision in both eyes
- •The participant may enter the study as a healthy control if ALL of the following apply:
- •Participant is willing and able to give informed consent for participation in the study
- •Fluent in English
- •Male or Female, aged 50 years or above
- •No history of neurological disease
- •No evidence of significant cognitive impairment
- •Normal or corrected-to-normal vision in both eyes
排除标准
- •The participant may not enter the study if ANY of the following apply:
- •Patient is unwilling or unable to give informed consent.
- •Significant neurological co-morbidity that may obfuscate interpretation of neurophysiological or cognitive test results, for example major stroke.
- •Severe mental impairment due to dementia or psychosis
- •Medical or psychiatric illness that would interfere with completing initial or any of the follow up assessments
- •History of photosensitive epilepsy
结局指标
主要结局
Saccadic eye movements
时间窗: 3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 months.
Automated measurements of rapid conjugate eye movements using a device called a saccadometer.
Mini Mental State Examination (MMSE) cognitive tablet
时间窗: 3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 months
This is a standard clinical test for cognitive impairment
Hand tapping
时间窗: 3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 months
Measurement of rate of hand tapping movements made by participant on an electronic pad.
Executive function testing (Oxford Cognitive Screen)
时间窗: 3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 months
This is an electronic tablet-based battery of tasks intended to screen for deficits in executive function.
Gait measurement
时间窗: 3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 months
Characterisation of gait abnormalities using a body-worn array of inertial measurement units
Montreal Cognitive Assessment (MOCA)
时间窗: 3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 months
This is a standard clinical test for cognitive impairment
Reaction times using a button box
时间窗: 3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 months
Measurement of response time when participant is required to press a button when a light is illuminated.
Verbal fluency test measurement
时间窗: 3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 months
Measures a participant's ability to produce a list of words according to set criteria e.g. words starting with a specific letter of the alphabet.
次要结局
未报告次要终点