Oxford Study of Quantification in Parkinsonism

NCT ID: NCT04139551

Last Updated: 2020-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-31

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Parkinson Disease Progressive Supranuclear Palsy

Keywords

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wearable technology Saccadic eye movements Gait assessment Cognitive tests

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1XXX Denono PD

Newly diagnosed unmedicated PD patients

No interventions assigned to this group

2XXX Mild /Moderate PD

Early to moderate stage PD patients well controlled on medication(typically fewer than 8 years since diagnosis)

No interventions assigned to this group

3XXX Advanced PD

Advanced PD patients (typically greater than 8 years duration)

No interventions assigned to this group

4XXX DBS patients

PD patients with deep brain stimulation systems

No interventions assigned to this group

5XXX PSP patients

PSP patients

No interventions assigned to this group

6XXX Healthy Controls

Age-frequency matched healthy controls

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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UCB Belgium

UNKNOWN

Sponsor Role collaborator

University of Oxford

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chrystalina A Antoniades

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

Locations

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John Radcliffe Hospital

Headington, Please Select, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Chrystalina A Antoniades, PhD

Role: CONTACT

Phone: 44 -1865 234728

Email: [email protected]

James J FitzGerald, PhD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Chrystalina Antoniades

Role: primary

References

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Lu Z, Buchanan T, Kennard C, FitzGerald JJ, Antoniades CA. The effect of levodopa on saccades - Oxford Quantification in Parkinsonism study. Parkinsonism Relat Disord. 2019 Nov;68:49-56. doi: 10.1016/j.parkreldis.2019.09.029. Epub 2019 Sep 27.

Reference Type RESULT
PMID: 31621619 (View on PubMed)

Patel S, Fitzgerald JJ, Antoniades CA. Oculomotor effects of medical and surgical treatments of Parkinson's disease. Prog Brain Res. 2019;249:297-305. doi: 10.1016/bs.pbr.2019.04.020. Epub 2019 May 20.

Reference Type RESULT
PMID: 31325988 (View on PubMed)

De Vos M, Prince J, Buchanan T, FitzGerald JJ, Antoniades CA. Discriminating progressive supranuclear palsy from Parkinson's disease using wearable technology and machine learning. Gait Posture. 2020 Mar;77:257-263. doi: 10.1016/j.gaitpost.2020.02.007. Epub 2020 Feb 10.

Reference Type RESULT
PMID: 32078894 (View on PubMed)

Related Links

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Other Identifiers

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16/SW/0262 REC reference

Identifier Type: OTHER

Identifier Source: secondary_id

IRAS ID 211382

Identifier Type: -

Identifier Source: org_study_id