Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-01-02 @ 10:17 AM
Study NCT ID:
NCT04139551
Status:
UNKNOWN
Last Update Posted:
2020-12-11
First Post:
2019-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oxford Study of Quantification in Parkinsonism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D013494', 'term': 'Supranuclear Palsy, Progressive'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D009886', 'term': 'Ophthalmoplegia'}, {'id': 'D015835', 'term': 'Ocular Motility Disorders'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-09', 'studyFirstSubmitDate': '2019-10-18', 'studyFirstSubmitQcDate': '2019-10-24', 'lastUpdatePostDateStruct': {'date': '2020-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Saccadic eye movements', 'timeFrame': '3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 months.', 'description': 'Automated measurements of rapid conjugate eye movements using a device called a saccadometer.'}, {'measure': 'Hand tapping', 'timeFrame': '3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 months', 'description': 'Measurement of rate of hand tapping movements made by participant on an electronic pad.'}, {'measure': 'Reaction times using a button box', 'timeFrame': '3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 months', 'description': 'Measurement of response time when participant is required to press a button when a light is illuminated.'}, {'measure': 'Gait measurement', 'timeFrame': '3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 months', 'description': 'Characterisation of gait abnormalities using a body-worn array of inertial measurement units'}, {'measure': 'Mini Mental State Examination (MMSE) cognitive tablet', 'timeFrame': '3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 months', 'description': 'This is a standard clinical test for cognitive impairment'}, {'measure': 'Montreal Cognitive Assessment (MOCA)', 'timeFrame': '3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 months', 'description': 'This is a standard clinical test for cognitive impairment'}, {'measure': 'Verbal fluency test measurement', 'timeFrame': '3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 months', 'description': "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."}, {'measure': 'Executive function testing (Oxford Cognitive Screen)', 'timeFrame': '3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 months', 'description': 'This is an electronic tablet-based battery of tasks intended to screen for deficits in executive function.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['wearable technology', 'Saccadic eye movements', 'Gait assessment', 'Cognitive tests'], 'conditions': ['Parkinson Disease', 'Progressive Supranuclear Palsy']}, 'referencesModule': {'references': [{'pmid': '31621619', 'type': 'RESULT', '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.'}, {'pmid': '31325988', 'type': 'RESULT', '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."}, {'pmid': '32078894', 'type': 'RESULT', 'citation': "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."}], 'seeAlsoLinks': [{'url': 'http://www.ndcn.ox.ac.uk/research/neurometrology-lab/', 'label': 'Group website'}]}, 'descriptionModule': {'briefSummary': "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.\n\nThis 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.\n\nDuring 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.", 'detailedDescription': '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.\n\nOne 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.\n\nThe 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.\n\nThe aim of this study is to develop and validate sensitive tests to measure the symptoms of PD and PSP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Parkinson's and Progressive Supranuclear Palsy patients along with aged - matched healthy controls.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The participant may enter the study as a patient participant if ALL of the following apply:\n\n * Participant is willing and able to give informed consent for participation in the study\n * Fluent in English\n * Male or Female, aged 50 years or above\n * 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)\n * No evidence of significant cognitive impairment\n * Normal or corrected-to-normal vision in both eyes\n\nThe participant may enter the study as a healthy control if ALL of the following apply:\n\n* Participant is willing and able to give informed consent for participation in the study\n* Fluent in English\n* Male or Female, aged 50 years or above\n* No history of neurological disease\n* No evidence of significant cognitive impairment\n* Normal or corrected-to-normal vision in both eyes\n\nExclusion Criteria:\n\nThe participant may not enter the study if ANY of the following apply:\n\n* Patient is unwilling or unable to give informed consent.\n* Significant neurological co-morbidity that may obfuscate interpretation of neurophysiological or cognitive test results, for example major stroke.\n* Severe mental impairment due to dementia or psychosis\n* Medical or psychiatric illness that would interfere with completing initial or any of the follow up assessments\n* History of photosensitive epilepsy'}, 'identificationModule': {'nctId': 'NCT04139551', 'acronym': 'OxQUIP', 'briefTitle': 'Oxford Study of Quantification in Parkinsonism', 'organization': {'class': 'OTHER', 'fullName': 'University of Oxford'}, 'officialTitle': 'Oxford Study of Quantification in Parkinsonism Study - OXQUIP', 'orgStudyIdInfo': {'id': 'IRAS ID 211382'}, 'secondaryIdInfos': [{'id': '16/SW/0262 REC reference', 'type': 'OTHER', 'domain': 'University of Oxford'}]}, 'armsInterventionsModule': {'armGroups': [{'label': '1XXX Denono PD', 'description': 'Newly diagnosed unmedicated PD patients'}, {'label': '2XXX Mild /Moderate PD', 'description': 'Early to moderate stage PD patients well controlled on medication(typically fewer than 8 years since diagnosis)'}, {'label': '3XXX Advanced PD', 'description': 'Advanced PD patients (typically greater than 8 years duration)'}, {'label': '4XXX DBS patients', 'description': 'PD patients with deep brain stimulation systems'}, {'label': '5XXX PSP patients', 'description': 'PSP patients'}, {'label': '6XXX Healthy Controls', 'description': 'Age-frequency matched healthy controls'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'OX3 9DU', 'city': 'Headington', 'state': 'Please Select', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Chrystalina Antoniades', 'role': 'CONTACT', 'email': 'Chrystalina.antoniades@ndcn.ox.ac.uk', 'phone': '07854838331'}], 'facility': 'John Radcliffe Hospital', 'geoPoint': {'lat': 51.75737, 'lon': -1.21974}}], 'centralContacts': [{'name': 'Chrystalina A Antoniades, PhD', 'role': 'CONTACT', 'email': 'chrystalina.antoniades@ndcn.ox.ac.uk', 'phone': '44 -1865 234728'}, {'name': 'James J FitzGerald, PhD', 'role': 'CONTACT', 'email': 'james.fitzgerald@nds.ox.ac.uk'}], 'overallOfficials': [{'name': 'Chrystalina A Antoniades', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oxford'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Data will be available two years after publication for a period of 10 years.', 'ipdSharing': 'YES', 'description': 'Via scientific publications and several collaborations that are already under way.', 'accessCriteria': 'Anyone interested can get in touch with our team and we will assess each request on case by case'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oxford', 'class': 'OTHER'}, 'collaborators': [{'name': 'UCB Belgium', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}