Parkinson DiseaseOxQUIPNCT04139551
Oxford Study of Quantification in Parkinsonism
An observational study of Parkinson Disease and Progressive Supranuclear Palsy, run by University of Oxford at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Progressive Supranuclear Palsy
- How many people
- 300 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2016to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Parkinson's and Progressive Supranuclear Palsy patients along with aged - matched healthy controls.
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
James J FitzGerald, PhD contact
United Kingdom1 site, 1 recruiting
- Recruiting
John Radcliffe Hospital
Headington, Please Select, OX3 9DU
Chrystalina Antoniades, 07854838331, Chrystalina.antoniades@ndcn.ox.ac.uk
About this study
Official title: 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.
Read the 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.
- Conditions
- Parkinson Disease, Progressive Supranuclear Palsy
- Keywords
- wearable technology, Saccadic eye movements, Gait assessment, Cognitive tests
- Medical subject headings
- Parkinson Disease, Supranuclear Palsy, Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1XXX Denono PD | Newly diagnosed unmedicated PD patients | |
| 2XXX Mild /Moderate PD | Early to moderate stage PD patients well controlled on medication(typically fewer than 8 years since diagnosis) | |
| 3XXX Advanced PD | Advanced PD patients (typically greater than 8 years duration) | |
| 4XXX DBS patients | PD patients with deep brain stimulation systems | |
| 5XXX PSP patients | PSP patients | |
| 6XXX Healthy Controls | Age-frequency matched healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Saccadic eye movements
Automated measurements of rapid conjugate eye movements using a device called a saccadometer.
Measured: 3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 months.
Hand tapping
Measurement of rate of hand tapping movements made by participant on an electronic pad.
Measured: 3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 months
Reaction times using a button box
Measurement of response time when participant is required to press a button when a light is illuminated.
Measured: 3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 months
Gait measurement
Characterisation of gait abnormalities using a body-worn array of inertial measurement units
Measured: 3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 months
Mini Mental State Examination (MMSE) cognitive tablet
This is a standard clinical test for cognitive impairment
Measured: 3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 months
Montreal Cognitive Assessment (MOCA)
This is a standard clinical test for cognitive impairment
Measured: 3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 months
Verbal fluency test measurement
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.
Measured: 3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 months
Executive function testing (Oxford Cognitive Screen)
This is an electronic tablet-based battery of tasks intended to screen for deficits in executive function.
Measured: 3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study startOct 2016
- Primary completionAug 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- UCB Belgium
- Responsible party
- Sponsor
- Investigators
- Chrystalina A Antoniades, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04139551
- Sponsor's protocol ID
- IRAS ID 211382
- Other IDs
- 16/SW/0262 REC reference
- Acronym
- OxQUIP
- Status last verified
- Aug 2020
- First submitted
- 18 Oct 2019
- Last updated
- 11 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Via scientific publications and several collaborations that are already under way.
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.
PubMed 31621619Patel 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.
PubMed 31325988De 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.
PubMed 32078894
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxford Study of Quantification in Parkinsonism Study - OXQUIP
- ClinicalTrials.gov ID
- NCT04139551
- Acronym / sponsor ID
- OxQUIP / IRAS ID 211382
- Conditions
- Parkinson Disease, Progressive Supranuclear Palsy
- Keywords
- wearable technology, Saccadic eye movements, Gait assessment, Cognitive tests
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- UCB Belgium
- Study start
- Oct 2016 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 25 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1XXX Denono PD | – | –Newly diagnosed unmedicated PD patients |
| 2XXX Mild /Moderate PD | – | –Early to moderate stage PD patients well controlled on medication(typically fewer than 8 years since diagnosis) |
| 3XXX Advanced PD | – | –Advanced PD patients (typically greater than 8 years duration) |
| 4XXX DBS patients | – | –PD patients with deep brain stimulation systems |
| 5XXX PSP patients | – | –PSP patients |
| 6XXX Healthy Controls | – | –Age-frequency matched healthy controls |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Parkinson's and Progressive Supranuclear Palsy patients along with aged - matched healthy controls.
Key inclusion criteria (14 listed)
- 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
- No history of neurological disease
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Saccadic eye movements
Time frame: 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.
Hand tapping
Time frame: 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.
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
Measurement of response time when participant is required to press a button when a light is illuminated.
Gait measurement
Time frame: 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
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
This is a standard clinical test for cognitive impairment
Montreal Cognitive Assessment (MOCA)
Time frame: 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
Verbal fluency test measurement
Time frame: 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.
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
This is an electronic tablet-based battery of tasks intended to screen for deficits in executive function.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2020.
- Results publication: PubMed 31621619Lu 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.
- Results publication: PubMed 31325988Patel 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.
- Results publication: PubMed 32078894De 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.
- Group websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Via scientific publications and several collaborations that are already under way.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James J FitzGerald, PhD contact
Chrystalina A Antoniades principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Progressive Supranuclear Palsy, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chrystalina A Antoniades, PhD (44 -1865 234728, chrystalina.antoniades@ndcn.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Saccadic eye movements (time frame: 3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 months.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04139551, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2020.