Oxford Study of Quantification in Parkinsonism (OxQUIP)

December 9, 2020 updated by: University of Oxford

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

Recruiting

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

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Parkinson's and Progressive Supranuclear Palsy patients along with aged - matched healthy controls.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 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.
Automated measurements of rapid conjugate eye movements using a device called a saccadometer.
3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 months.
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.
3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 months
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.
3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 months
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
3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 months
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
3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 months
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
3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 months
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.
3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 months
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.
3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Chrystalina A Antoniades, University of Oxford

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2016

Primary Completion (ANTICIPATED)

August 1, 2023

Study Completion (ANTICIPATED)

December 1, 2023

Study Registration Dates

First Submitted

October 18, 2019

First Submitted That Met QC Criteria

October 24, 2019

First Posted (ACTUAL)

October 25, 2019

Study Record Updates

Last Update Posted (ACTUAL)

December 11, 2020

Last Update Submitted That Met QC Criteria

December 9, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Via scientific publications and several collaborations that are already under way.

IPD Sharing Time Frame

Data will be available two years after publication for a period of 10 years.

IPD Sharing Access Criteria

Anyone interested can get in touch with our team and we will assess each request on case by case

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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