Oxford Study of Quantification in Parkinsonism

NCT04139551 | Unknown DMC

• 2 other identifiers: IRAS ID 21138216/SW/0262 REC reference
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Progressive Supranuclear Palsy

Keywords

wearable technology; Saccadic eye movements; Gait assessment; Cognitive tests

Outcome Measures

Primary Outcomes (8)

• 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.

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (6)

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

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oxford: lead
• UCB Belgium: collaborator

Study Sites (1)

John Radcliffe Hospital

Headington, Please Select, OX3 9DU, United Kingdom

RECRUITING

Related Publications (3)

• 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.

  PMID: 31621619 RESULT

• 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.

  PMID: 31325988 RESULT

• 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.

  PMID: 32078894 RESULT

Related Links

• Group website

MeSH Terms

Conditions

Parkinson Disease; Supranuclear Palsy, Progressive

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Tauopathies; Paralysis; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Chrystalina A Antoniades

  University of Oxford

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chrystalina A Antoniades, PhD

CONTACT

44 -1865 234728; chrystalina.antoniades@ndcn.ox.ac.uk

James J FitzGerald, PhD

CONTACT

james.fitzgerald@nds.ox.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2019
• First Posted: October 25, 2019
• Study Start: October 1, 2016
• Primary Completion: August 1, 2023
• Study Completion: December 1, 2023
• Last Updated: December 11, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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

Locations

GB (1)