Oxford Study of Quantification in Parkinsonism (OxQUIP)

  • STATUS
    Recruiting
  • End date
    Dec 27, 2023
  • participants needed
    300
  • sponsor
    University of Oxford
Updated on 26 January 2022
cognitive impairment
parkinson's disease
neurological disorder
parkinsonism
progressive supranuclear palsy
Accepts healthy volunteers

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.

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.

Details
Condition Parkinson Disease, Progressive Supranuclear Palsy
Clinical Study IdentifierNCT04139551
SponsorUniversity of Oxford
Last Modified on26 January 2022

Eligibility

Yes No Not Sure

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
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What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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