Brief Title
Oxford Study of Quantification in Parkinsonism
Official Title
Oxford Study of Quantification in Parkinsonism Study - OXQUIP
Brief 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. 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 Type
Observational
Primary Outcome
Saccadic eye movements
Condition
Parkinson Disease
Study Arms / Comparison Groups
1XXX Denono PD
Description: Newly diagnosed unmedicated PD patients
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
300
Start Date
October 2016
Completion Date
December 2023
Primary Completion Date
August 2023
Eligibility Criteria
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
Gender
All
Ages
50 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Chrystalina A Antoniades, 44 -1865 234728, [email protected]
Location Countries
United Kingdom
Location Countries
United Kingdom
Administrative Informations
NCT ID
NCT04139551
Organization ID
IRAS ID 211382
Secondary IDs
16/SW/0262 REC reference
Responsible Party
Sponsor
Study Sponsor
University of Oxford
Collaborators
UCB Belgium
Study Sponsor
Chrystalina A Antoniades, Principal Investigator, University of Oxford
Verification Date
August 2020