Oxford Study of Quantification in Parkinsonism

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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