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Oxford Study of Quantification in Parkinsonism (OxQUIP)

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ClinicalTrials.gov Identifier: NCT04139551
Recruitment Status : Recruiting
First Posted : October 25, 2019
Last Update Posted : October 25, 2019
Sponsor:
Collaborator:
UCB Belgium
Information provided by (Responsible Party):
University of Oxford

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.


Condition or disease
Parkinson Disease Progressive Supranuclear Palsy

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.


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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Oxford Study of Quantification in Parkinsonism Study - OXQUIP
Actual Study Start Date : October 2016
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : April 2022


Group/Cohort
OQ - 01- 1XXX Denono PD
Newly diagnosed unmedicated PD patients
OQ-01- 2XXX Mild /Moderate PD
Early to moderate stage PD patients well controlled on medication(typically fewer than 8 years since diagnosis)
OQ-01- 3XXX Advanced PD
Advanced PD patients (typically greater than 8 years duration)
OQ-01- 4XXX DBS patients
PD patients with deep brain stimulation systems
OQ-01- 5XXX PSP patients
PSP patients
OQ-01- 6XXX Healthy Controls
Age-frequency matched healthy controls



Primary Outcome Measures :
  1. 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.

  2. 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. 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.

  4. 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

  5. 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

  6. 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

  7. 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.

  8. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Parkinson's and Progressive Supranuclear Palsy patients along with aged - matched healthy controls.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04139551


Contacts
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Contact: Chrystalina A Antoniades, PhD 44 -1865 234728 chrystalina.antoniades@ndcn.ox.ac.uk
Contact: James J FitzGerald, PhD james.fitzgerald@nds.ox.ac.uk

Locations
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United Kingdom
John Radcliffe Hospital Recruiting
Headington, Please Select, United Kingdom, OX3 9DU
Contact: Chrystalina Antoniades    07854838331    Chrystalina.antoniades@ndcn.ox.ac.uk   
Sponsors and Collaborators
University of Oxford
UCB Belgium
Investigators
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Principal Investigator: Chrystalina A Antoniades University of Oxford

Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT04139551     History of Changes
Other Study ID Numbers: IRAS ID 211382
16/SW/0262 REC reference ( Other Identifier: University of Oxford )
First Posted: October 25, 2019    Key Record Dates
Last Update Posted: October 25, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Via scientific publications and several collaborations that are already under way.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data will be available two years after publication for a period of 10 years.
Access Criteria: Anyone interested can get in touch with our team and we will assess each request on case by case

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Oxford:
wearable technology
Saccadic eye movements
Gait assessment
Cognitive tests
Additional relevant MeSH terms:
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Parkinson Disease
Supranuclear Palsy, Progressive
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Ophthalmoplegia
Ocular Motility Disorders
Cranial Nerve Diseases
Tauopathies
Paralysis
Neurologic Manifestations
Eye Diseases
Signs and Symptoms