Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-25 @ 8:35 PM
Study NCT ID:
NCT06136169
Status:
RECRUITING
Last Update Posted:
2025-08-11
First Post:
2023-11-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Reminder-cue Scanning Training for Homonymous Visual Field Loss
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006423', 'term': 'Hemianopsia'}], 'ancestors': [{'id': 'D014786', 'term': 'Vision Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001766', 'term': 'Blindness'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-06', 'studyFirstSubmitDate': '2023-11-09', 'studyFirstSubmitQcDate': '2023-11-14', 'lastUpdatePostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of early large head scans to the side of the field loss', 'timeFrame': 'Pre-training, post-training (1 week)', 'description': 'Proportion of intersections at which an early large head scan was made to the side of the field loss'}, {'measure': 'Detection rate for hazards on the side of the field loss', 'timeFrame': 'Pre-training, Post-training (1 week)', 'description': 'Proportion of hazards detected out of the total number of hazards on the side of the field loss'}], 'secondaryOutcomes': [{'measure': 'Rate of early large head scans to the side of the field loss', 'timeFrame': 'Pre-training, post-training (up to 12 months)', 'description': 'Proportion of intersections at which an early large head scan was made to the side of the field loss'}, {'measure': 'Frequency of head scans to the side of the field loss', 'timeFrame': 'Pre-training, Post-training (up to 12 months)', 'description': 'Number of head scans per intersection to the side of the field loss'}, {'measure': 'Magnitude of head scans to the side of the field loss', 'timeFrame': 'Pre-training, Post-training (up to 12 months)', 'description': 'Mean magnitude (in degrees) of head scans to the side of the field loss'}, {'measure': 'Detection rate for hazards on the side of the field loss', 'timeFrame': 'Pre-training, post-training (up to 12 months)', 'description': 'Proportion of hazards detected out of the total number of hazards on the side of the field loss'}, {'measure': 'Response times to hazards on the side of the field loss', 'timeFrame': 'Pre-training, Post-training (up to 12 months)', 'description': 'Mean time (in seconds) between the hazard appearing and the horn-press response'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Homonymous Hemianopia', 'Homonymous Quadrantanopia']}, 'descriptionModule': {'briefSummary': 'This study will evaluate a new approach to training people with visual field loss to scan when driving', 'detailedDescription': 'Homonymous visual field loss is the loss of vision on the same side in both eyes. The most common types are hemianopia (the loss of one half of the field of vision) and quadrantanopia (the loss of one quarter of the field of vision). Hemianopia and quadrantanopia may cause difficulties in seeing objects on the side of the field loss. People with these types of field loss can compensate by scanning (looking) toward the side of the field loss. However, sometimes they might not scan sufficiently well resulting in delayed responses to hazards when driving. The purpose of this research study is to evaluate a new approach, "reminder-cue scanning training", to training people with homonymous visual field loss to scan when driving.\n\nParticipants will receive reminder-cue scanning training in the driving simulator.Typically there will be three training sessions within about a 2-week period. In addition, participants will complete an evaluation in the driving simulator before and after the training.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Homonymous hemianopia or homonymous quadrantanopia for at least 3 months\n* Binocular visual acuity of at least 20/40\n* Prior or current driving experience\n* Able to attend multiple study visits\n* Able to communicate in English sufficiently to understand the study procedures\n\nExclusion Criteria:\n\n* Physical or general health problems that could impair the ability to operate the controls of the driving simulator or participate in the training'}, 'identificationModule': {'nctId': 'NCT06136169', 'briefTitle': 'Reminder-cue Scanning Training for Homonymous Visual Field Loss', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts Eye and Ear Infirmary'}, 'officialTitle': 'Reminder-cue Scanning Training for People With Homonymous Visual Field Loss', 'orgStudyIdInfo': {'id': 'HST_Pilot'}, 'secondaryIdInfos': [{'id': 'R01EY025677', 'link': 'https://reporter.nih.gov/quickSearch/R01EY025677', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'StudyArm', 'description': 'Participants will receive reminder-cue scanning training in a driving simulator.', 'interventionNames': ['Behavioral: Reminder-cue scanning training']}], 'interventions': [{'name': 'Reminder-cue scanning training', 'type': 'BEHAVIORAL', 'description': 'Auditory reminders to scan when scanning to the side of the field loss is inadequate', 'armGroupLabels': ['StudyArm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alex Bowers, PhD', 'role': 'CONTACT', 'email': 'alex_bowers@meei.harvard.edu', 'phone': '617-912-2512'}], 'facility': 'Schepens Eye Research Institute of Mass Eye and Ear', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Alex Bowers, PhD', 'role': 'CONTACT', 'email': 'alex_bowers@meei.harvard.edu', 'phone': '617 912 2512'}], 'overallOfficials': [{'name': 'Alex Bowers, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Schepens Eye Research Institute of Mass Eye and Ear'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts Eye and Ear Infirmary', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Eye Institute (NEI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Scientist', 'investigatorFullName': 'Alexandra Bowers', 'investigatorAffiliation': 'Massachusetts Eye and Ear Infirmary'}}}}