Oxford Study of Quantification in Parkinsonism

Parkinson Disease Clinical Trial

— OxQUIP  

Official title:

Oxford Study of Quantification in Parkinsonism Study - OXQUIP

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04139551
• Other study ID #: IRAS ID 211382
• Secondary ID: 16/SW/0262 REC r
• Status: Recruiting
• Start date: October 2016
• Est. completion date: December 2023

Study information

• Verified date: August 2020
• Source: University of Oxford
• Contact: Chrystalina A Antoniades, PhD
• Phone: 44 -1865 234728
• Email: chrystalina.antoniades[@]ndcn.ox.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinsonian Disorders
• Progressive Supranuclear Palsy
• Supranuclear Palsy, Progressive

Locations

Country	Name	City	State
United Kingdom	John Radcliffe Hospital	Headington	Please Select

Sponsors (2)

Lead Sponsor	Collaborator
University of Oxford	UCB Belgium

Country where clinical trial is conducted

United Kingdom, 

References & Publications (3)

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. Ep — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Saccadic eye movements	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.
Primary	Hand tapping	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
Primary	Reaction times using a button box	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
Primary	Gait measurement	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
Primary	Mini Mental State Examination (MMSE) cognitive tablet	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
Primary	Montreal Cognitive Assessment (MOCA)	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
Primary	Verbal fluency test measurement	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
Primary	Executive function testing (Oxford Cognitive Screen)	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

External Links

•   Group website