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Oxford Study of Quantification in Parkinsonism

Oxford Study of Quantification in Parkinsonism Study - OXQUIP

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04139551
Acronym
OxQUIP
Enrollment
300
Registered
2019-10-25
Start date
2016-10-31
Completion date
2023-12-31
Last updated
2020-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease, Progressive Supranuclear Palsy

Keywords

wearable technology, Saccadic eye movements, Gait assessment, Cognitive tests

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.

Interventions

None listed

Sponsors

UCB Belgium
CollaboratorUNKNOWN
University of Oxford
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Saccadic eye movements3 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 tapping3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 monthsMeasurement of rate of hand tapping movements made by participant on an electronic pad.
Reaction times using a button box3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 monthsMeasurement of response time when participant is required to press a button when a light is illuminated.
Gait measurement3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 monthsCharacterisation of gait abnormalities using a body-worn array of inertial measurement units
Mini Mental State Examination (MMSE) cognitive tablet3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 monthsThis is a standard clinical test for cognitive impairment
Montreal Cognitive Assessment (MOCA)3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 monthsThis is a standard clinical test for cognitive impairment
Verbal fluency test measurement3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 monthsMeasures 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)3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 monthsThis is an electronic tablet-based battery of tasks intended to screen for deficits in executive function.

Countries

United Kingdom

Contacts

Primary ContactChrystalina A Antoniades, PhD
chrystalina.antoniades@ndcn.ox.ac.uk44 -1865 234728
Backup ContactJames J FitzGerald, PhD
james.fitzgerald@nds.ox.ac.uk

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026