- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04139551
Oxford Study of Quantification in Parkinsonism (OxQUIP)
Oxford Study of Quantification in Parkinsonism Study - OXQUIP
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.
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Chrystalina A Antoniades, PhD
- Phone Number: 44 -1865 234728
- Email: chrystalina.antoniades@ndcn.ox.ac.uk
Study Contact Backup
- Name: James J FitzGerald, PhD
- Email: james.fitzgerald@nds.ox.ac.uk
Study Locations
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Please Select
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Headington, Please Select, United Kingdom, OX3 9DU
- Recruiting
- John Radcliffe Hospital
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Contact:
- Chrystalina Antoniades
- Phone Number: 07854838331
- Email: Chrystalina.antoniades@ndcn.ox.ac.uk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
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
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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1XXX Denono PD
Newly diagnosed unmedicated PD patients
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2XXX Mild /Moderate PD
Early to moderate stage PD patients well controlled on medication(typically fewer than 8 years since diagnosis)
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3XXX Advanced PD
Advanced PD patients (typically greater than 8 years duration)
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4XXX DBS patients
PD patients with deep brain stimulation systems
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5XXX PSP patients
PSP patients
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6XXX Healthy Controls
Age-frequency matched healthy controls
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Saccadic eye movements
Time Frame: 3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 months.
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Automated measurements of rapid conjugate eye movements using a device called a saccadometer.
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3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 months.
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Hand tapping
Time Frame: 3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 months
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Measurement of rate of hand tapping movements made by participant on an electronic pad.
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3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 months
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Reaction times using a button box
Time Frame: 3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 months
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Measurement of response time when participant is required to press a button when a light is illuminated.
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3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 months
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Gait measurement
Time Frame: 3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 months
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Characterisation of gait abnormalities using a body-worn array of inertial measurement units
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3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 months
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Mini Mental State Examination (MMSE) cognitive tablet
Time Frame: 3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 months
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This is a standard clinical test for cognitive impairment
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3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 months
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Montreal Cognitive Assessment (MOCA)
Time Frame: 3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 months
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This is a standard clinical test for cognitive impairment
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3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 months
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Verbal fluency test measurement
Time Frame: 3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 months
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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.
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3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 months
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Executive function testing (Oxford Cognitive Screen)
Time Frame: 3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 months
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This is an electronic tablet-based battery of tasks intended to screen for deficits in executive function.
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3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Chrystalina A Antoniades, University of Oxford
Publications and helpful links
General Publications
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Eye Diseases
- Neurologic Manifestations
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Tauopathies
- Cranial Nerve Diseases
- Ocular Motility Disorders
- Paralysis
- Ophthalmoplegia
- Parkinson Disease
- Parkinsonian Disorders
- Supranuclear Palsy, Progressive
Other Study ID Numbers
- IRAS ID 211382
- 16/SW/0262 REC reference (OTHER: University of Oxford)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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