Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
300 participants
OBSERVATIONAL
2016-10-31
2023-12-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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1XXX Denono PD
Newly diagnosed unmedicated PD patients
No interventions assigned to this group
2XXX Mild /Moderate PD
Early to moderate stage PD patients well controlled on medication(typically fewer than 8 years since diagnosis)
No interventions assigned to this group
3XXX Advanced PD
Advanced PD patients (typically greater than 8 years duration)
No interventions assigned to this group
4XXX DBS patients
PD patients with deep brain stimulation systems
No interventions assigned to this group
5XXX PSP patients
PSP patients
No interventions assigned to this group
6XXX Healthy Controls
Age-frequency matched healthy controls
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
50 Years
ALL
Yes
Sponsors
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UCB Belgium
UNKNOWN
University of Oxford
OTHER
Responsible Party
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Principal Investigators
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Chrystalina A Antoniades
Role: PRINCIPAL_INVESTIGATOR
University of Oxford
Locations
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John Radcliffe Hospital
Headington, Please Select, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Chrystalina Antoniades
Role: primary
References
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Lu Z, Buchanan T, Kennard C, FitzGerald JJ, Antoniades CA. The effect of levodopa on saccades - Oxford Quantification in Parkinsonism study. Parkinsonism Relat Disord. 2019 Nov;68:49-56. doi: 10.1016/j.parkreldis.2019.09.029. Epub 2019 Sep 27.
Patel S, Fitzgerald JJ, Antoniades CA. Oculomotor effects of medical and surgical treatments of Parkinson's disease. Prog Brain Res. 2019;249:297-305. doi: 10.1016/bs.pbr.2019.04.020. Epub 2019 May 20.
De Vos M, Prince J, Buchanan T, FitzGerald JJ, Antoniades CA. Discriminating progressive supranuclear palsy from Parkinson's disease using wearable technology and machine learning. Gait Posture. 2020 Mar;77:257-263. doi: 10.1016/j.gaitpost.2020.02.007. Epub 2020 Feb 10.
Related Links
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Group website
Other Identifiers
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16/SW/0262 REC reference
Identifier Type: OTHER
Identifier Source: secondary_id
IRAS ID 211382
Identifier Type: -
Identifier Source: org_study_id