Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-31 @ 5:04 AM
Study NCT ID:
NCT04560504
Status:
COMPLETED
Last Update Posted:
2024-10-29
First Post:
2020-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Oculomotor Training in Parkinson's Disease
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-28', 'studyFirstSubmitDate': '2020-09-07', 'studyFirstSubmitQcDate': '2020-09-22', 'lastUpdatePostDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Smooth Vergence eye movements', 'timeFrame': 'Change from baseline at week 4 and change from baseline at week 12', 'description': 'Smooth vergence eye movement is measured using a head-mounted eye tracking while fixating at an approaching target moving at different speeds'}], 'secondaryOutcomes': [{'measure': 'Oculomotor characteristics', 'timeFrame': 'Change from baseline at week 4 and change from baseline at week 12', 'description': "With the use of eye tracking device, eye movement behavior of participants can be measured and analysed while performing the following tasks.\n\n1. Fixation task - Fixate at stationary target presented on a monitor\n2. Saccade task - Follow and fixate at a random jumping target presented on a monitor\n3. Pursuit task - Follow accurately and steadily on a smooth moving target presented on a monitor\n4. Jump Vergence task - Follow and fixate a jumping target presented in the anterior-posterior plane (jumping from 'far to near' or 'near to far')"}, {'measure': 'Sentence reading performance', 'timeFrame': 'Change from baseline at week 4 and change from baseline at week 12', 'description': 'To evaluate the effectiveness of the interventions on sentence reading using MNREAD charts in Chinese. These charts developed in our laboratory are used to measure the effectiveness of sentence reading in terms of reading speed and critical print size.'}, {'measure': 'Passage reading performance', 'timeFrame': 'Change from baseline at week 4 and change from baseline at week 12', 'description': 'To evaluate the effectiveness of the interventions on passage reading using International Reading speed Test (IReST). IReST is used to evaluate the effectiveness of passage reading performance by measuring the reading speed.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Parkinson Disease', 'Oculomotor deficit', 'Oculomotor training', 'Dynamic vision'], 'conditions': ['Parkinson Disease', 'Oculomotor; Disorder']}, 'descriptionModule': {'briefSummary': "Parkinson's disease (PD) is a common neurodegenerative disorder which is characterized by both motor and non-motor symptoms and usually affects people aged 50 years or above. Many studies showed eye movement deficits and visual changes in patients with PD.\n\nPrevious studies have also indicated that clinical eye movement training could enhance the functional performance of patients with various eye movement problems resulting from ocular and neurodegenerative diseases.\n\nIn this study, we will investigate the effectiveness of eye movement training on dynamic vision and functional performance in PD patients with oculomotor deficits."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Parkinson's Disease diagnosed by a neurologist or geriatrician with the range of Stage\n\n 1 to 4 (Hoehn and Yahr Classification)\n* Able to speak and comprehend Cantonese dialect\n* Able to travel independently\n\nExclusion Criteria:\n\n* Any congenital eye problem (e.g. congenital strabismus or amblyopia in either eye) or any manifest eye diseases (e.g. macular degeneration, glaucoma, etc)\n* Severe medical problems (e.g. stroke)\n* Cognitive impairment (e.g. dementia)\n* Presence of any psychiatric or neurological diseases (apart from Parkinson's disease) or receiving of any psychoactive pharmacological treatment\n* Receiving any medication that is known to affect eye movement and cognitive function\n* Previous formal vision rehabilitation or oculomotor intervention"}, 'identificationModule': {'nctId': 'NCT04560504', 'briefTitle': "Effectiveness of Oculomotor Training in Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'The Hong Kong Polytechnic University'}, 'officialTitle': "Oculomotor Deficits in Parkinson's Disease: Enhancing Eye Movement Performance and Dynamic Visual Acuity With Oculomotor Training Using a Pilot Randomized Clinical Trial Design", 'orgStudyIdInfo': {'id': '15102717'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': 'Receive 10 sessions of 45-minute (3 sessions per week) in-office leisure activities e.g. simple non-action computer games or board games (e.g. card and chess games) and 10-20 minutes of video watching at home', 'interventionNames': ['Other: Control Group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention Group', 'description': 'Receive 10 sessions of 45-minute office training (3 sessions per week) and 10-20 minute home training (3 sessions per week) of eye movement training', 'interventionNames': ['Other: Oculomotor Training Group']}], 'interventions': [{'name': 'Control Group', 'type': 'OTHER', 'description': 'Leisure activities', 'armGroupLabels': ['Control Group']}, {'name': 'Oculomotor Training Group', 'type': 'OTHER', 'description': 'Eye movement training', 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Allen MY Cheong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Allen Ming Yan Cheong, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Hong Kong Polytechnic University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hong Kong Polytechnic University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of California, Berkeley', 'class': 'OTHER'}, {'name': 'Deakin University', 'class': 'OTHER'}, {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, {'name': 'Hospital Authority, Hong Kong', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Allen MY Cheong', 'investigatorAffiliation': 'The Hong Kong Polytechnic University'}}}}