Ignite Creation Date:
2025-12-24 @ 7:25 PM
Ignite Modification Date:
2025-12-25 @ 5:05 PM
Study NCT ID:
NCT05437003
Status:
COMPLETED
Last Update Posted:
2024-02-16
First Post:
2022-06-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Prospective Study to Evaluate the Correlation Between Oculometric Measurements and Clinical Endpoints in PD Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 465}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-15', 'studyFirstSubmitDate': '2022-06-23', 'studyFirstSubmitQcDate': '2022-06-23', 'lastUpdatePostDateStruct': {'date': '2024-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between MDS-UPDRS score and its parts with NeuraLight oculometric measurements', 'timeFrame': '12 months', 'description': "The correlation between MDS-UPDRS score and its parts with NeuraLight oculometric measurements (R-Square\\>0.5, p\\<0.05) according to the Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) at every visit"}, {'measure': 'Feasibility of using NeuraLight system to capture oculometric measures in a cohort of PD patients and healthy subjects', 'timeFrame': '12 months', 'description': 'Capturing \\>50 different oculometric measures in \\>95% of a cohort of about 1000 patients'}, {'measure': 'Comparison of NeuraLight extracted oculometric measures with a validated eye-tracking system', 'timeFrame': '12 months', 'description': "Relative root mean square error (RMSE) of NeuraLight's extracted oculometric measures compared with retrieved measurements from a validated eye tracking system \\<0.1"}], 'secondaryOutcomes': [{'measure': 'Using the retrieved data of collected NeuraLight oculometric measures for calibration of prediction models of MDS-UPDRS clinical endpoint', 'timeFrame': '12 months', 'description': "Optimization of a feature selection model (Fisher's Linear Discriminant Analysis (LDA)) on NeuraLight oculometric measures used for a logistic regression model of MDS-UPDRS with a relative root mean square error (RMSE) of \\<0.1"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Idiopathic Parkinson Disease']}, 'referencesModule': {'references': [{'pmid': '23338283', 'type': 'BACKGROUND', 'citation': 'Anderson TJ, MacAskill MR. Eye movements in patients with neurodegenerative disorders. Nat Rev Neurol. 2013 Feb;9(2):74-85. doi: 10.1038/nrneurol.2012.273. Epub 2013 Jan 22.'}, {'pmid': '31263745', 'type': 'BACKGROUND', 'citation': "Waldthaler J, Tsitsi P, Svenningsson P. Vertical saccades and antisaccades: complementary markers for motor and cognitive impairment in Parkinson's disease. NPJ Parkinsons Dis. 2019 Jun 24;5:11. doi: 10.1038/s41531-019-0083-7. eCollection 2019."}]}, 'descriptionModule': {'briefSummary': "This is a prospective study in a cohort of about 500 patients with Idiopathic Parkinson's disease, examined routinely in the neurological outpatient clinic.\n\nThis study aims to evaluate the correlation between oculometric measures and clinical endpoints. Subjects will be evaluated following a physician examination.The evaluations will include MDS-UPDRS examination, as well as an oculometric evaluation for eye movements. In addition, 500 healthy subjects will be evaluated.", 'detailedDescription': "This is a prospective study in a cohort of patients with idiopathic PD who are visiting the Parkinson's outpatient clinic. The aim of the study is to evaluate the correlation between oculometric measures and MDS-UPDRS score in subjects who meet the inclusion criteria and who provide a signed Informed Consent.\n\nThis study is designed to evaluate the correlation between oculometric measures and the Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS). Subjects will be evaluated at their visit to the clinic. The evaluations will include an MDS-UPDRS examination by a certified neurologist and other tests. In addition, all patients will undergo a NeuraLight session for oculometric evaluation along with eye-tracking recordings. All assessments will be performed during a clinic visit unless authorized to be conducted remotely. In addition, 500 healthy subjects will be evaluated, undergoing a NeuraLight session for oculometric evaluation along with eye-tracking recordings."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'PD patients:\n\nInclusion Criteria:\n\n* Men and women with idiopathic PD (Hoehn \\& Yahr scale 1-5)\n* Age between 18 and 85 years old\n* Normal or corrected vision\n* Ability to follow instructions\n* Willing and able to sign an informed consent form\n\nExclusion Criteria:\n\n* Inability to sit for 20 minutes on a chair in a calm manner\n* Personal or 1st degree relative history of epilepsy\n* Additional neurological diseases\n* Drug or alcohol abuse\n\nHealthy subjects:\n\nInclusion Criteria:\n\n* Age between 18 and 85 years old\n* Normal or corrected vision\n* Ability to follow instructions\n* Willing and able to sign an informed consent form\n\nExclusion Criteria\n\n* Inability to sit for 20 minutes on a chair in a calm manner\n* Personal or 1st degree relative history of epilepsy\n* Neurological diseases\n* Drug or alcohol abuse'}, 'identificationModule': {'nctId': 'NCT05437003', 'briefTitle': 'A Prospective Study to Evaluate the Correlation Between Oculometric Measurements and Clinical Endpoints in PD Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'NeuraLight'}, 'officialTitle': "A Cross-Sectional Study to Evaluate the Correlation Between Oculometric Measures and MDS-UPDRS in Patients With Idiopathic Parkinson's Disease (PD) and Evaluation of Oculometric Measures in Healthy Participants", 'orgStudyIdInfo': {'id': 'NL/PD/2022-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PD patients visiting clinic', 'description': 'All patients will undergo a NeuraLight session for oculometric evaluation along with eye-tracking recordings. All assessments will be performed during a clinic visit unless authorized to be conducted remotely.', 'interventionNames': ['Other: NeuraLight software-based platform']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy subjects', 'description': 'All patients will undergo a NeuraLight session for oculometric evaluation along with eye-tracking recordings. All assessments will be performed during a visit unless authorized to be conducted remotely.', 'interventionNames': ['Other: NeuraLight software-based platform']}], 'interventions': [{'name': 'NeuraLight software-based platform', 'type': 'OTHER', 'description': 'NeuraLight is an investigational software-based platform that is used for assessment and evaluation of neurological conditions including PD patients', 'armGroupLabels': ['Healthy subjects', 'PD patients visiting clinic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4941492', 'city': 'Petah Tikva', 'country': 'Israel', 'facility': 'Rabin Medical Center', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}], 'overallOfficials': [{'name': 'Johnathan Reiner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sackler Faculty of Medicine, Tel Aviv University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is not plan to share IPD with other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NeuraLight', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}