Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-27 @ 10:50 PM
Study NCT ID:
NCT05894434
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-30
First Post:
2023-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ameliorating Stroke-induced Hemianopia Via Multisensory Training
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006423', 'term': 'Hemianopsia'}, {'id': 'D019575', 'term': 'Blindness, Cortical'}], '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The experimental and control paradigms are based on sensory stimulation and there is no practical way to mask the participant from its nature, although they are not informed as to what the expected results will be. The outcomes assessor will be blinded to which stimulation arm preceded the data collection.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'There are two principal sub-studies: standard intervention and early intervention. Each sub-study contains a multisensory training group (experimental arm) and a unisensory training group (control arm). The unisensory training group crosses over to multisensory training at its completion. Thus, the model design is both factorial and crossover.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-29', 'studyFirstSubmitDate': '2023-05-30', 'studyFirstSubmitQcDate': '2023-05-30', 'lastUpdatePostDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Ophthalmological Test Scores', 'timeFrame': 'Baseline', 'description': "Humphrey tests - The Humphrey visual field test measures the entire area of peripheral vision that can be seen while the eye is focused on a central point. During this test, lights of varying intensities appear in different parts of the visual field while the patient's eye is focused on a certain spot. A normal visual field extends approximately 100° temporally (laterally), 60° nasally, 60° superiorly, and 70° inferiorly. A normal visual field measures about: 90 degrees temporally. 50 degrees superiorly and nasally. 60 degrees inferiorly"}, {'measure': 'Clinical Ophthalmological Test Scores', 'timeFrame': 'Day 15', 'description': "Humphrey tests - The Humphrey visual field test measures the entire area of peripheral vision that can be seen while the eye is focused on a central point. During this test, lights of varying intensities appear in different parts of the visual field while the patient's eye is focused on a certain spot. A normal visual field extends approximately 100° temporally (laterally), 60° nasally, 60° superiorly, and 70° inferiorly. A normal visual field measures about: 90 degrees temporally. 50 degrees superiorly and nasally. 60 degrees inferiorly"}, {'measure': 'Clinical Ophthalmological Test Scores', 'timeFrame': 'Week 8', 'description': "Humphrey tests - The Humphrey visual field test measures the entire area of peripheral vision that can be seen while the eye is focused on a central point. During this test, lights of varying intensities appear in different parts of the visual field while the patient's eye is focused on a certain spot. A normal visual field extends approximately 100° temporally (laterally), 60° nasally, 60° superiorly, and 70° inferiorly. A normal visual field measures about: 90 degrees temporally. 50 degrees superiorly and nasally. 60 degrees inferiorly"}, {'measure': 'Clinical Ophthalmological Test Scores', 'timeFrame': 'Week 10', 'description': "Humphrey tests - The Humphrey visual field test measures the entire area of peripheral vision that can be seen while the eye is focused on a central point. During this test, lights of varying intensities appear in different parts of the visual field while the patient's eye is focused on a certain spot. A normal visual field extends approximately 100° temporally (laterally), 60° nasally, 60° superiorly, and 70° inferiorly. A normal visual field measures about: 90 degrees temporally. 50 degrees superiorly and nasally. 60 degrees inferiorly"}, {'measure': 'Clinical Ophthalmological Test Scores', 'timeFrame': 'Week 16', 'description': "Humphrey tests - The Humphrey visual field test measures the entire area of peripheral vision that can be seen while the eye is focused on a central point. During this test, lights of varying intensities appear in different parts of the visual field while the patient's eye is focused on a certain spot. A normal visual field extends approximately 100° temporally (laterally), 60° nasally, 60° superiorly, and 70° inferiorly. A normal visual field measures about: 90 degrees temporally. 50 degrees superiorly and nasally. 60 degrees inferiorly"}, {'measure': 'Clinical Ophthalmological Test Scores', 'timeFrame': 'Week 48', 'description': "Humphrey tests - The Humphrey visual field test measures the entire area of peripheral vision that can be seen while the eye is focused on a central point. During this test, lights of varying intensities appear in different parts of the visual field while the patient's eye is focused on a certain spot. A normal visual field extends approximately 100° temporally (laterally), 60° nasally, 60° superiorly, and 70° inferiorly. A normal visual field measures about: 90 degrees temporally. 50 degrees superiorly and nasally. 60 degrees inferiorly"}, {'measure': 'Clinical Ophthalmological Test Scores', 'timeFrame': 'Week 50', 'description': "Humphrey tests - The Humphrey visual field test measures the entire area of peripheral vision that can be seen while the eye is focused on a central point. During this test, lights of varying intensities appear in different parts of the visual field while the patient's eye is focused on a certain spot. A normal visual field extends approximately 100° temporally (laterally), 60° nasally, 60° superiorly, and 70° inferiorly. A normal visual field measures about: 90 degrees temporally. 50 degrees superiorly and nasally. 60 degrees inferiorly"}, {'measure': 'Clinical Ophthalmological Test Scores', 'timeFrame': 'Week 56', 'description': "Humphrey tests - The Humphrey visual field test measures the entire area of peripheral vision that can be seen while the eye is focused on a central point. During this test, lights of varying intensities appear in different parts of the visual field while the patient's eye is focused on a certain spot. A normal visual field extends approximately 100° temporally (laterally), 60° nasally, 60° superiorly, and 70° inferiorly. A normal visual field measures about: 90 degrees temporally. 50 degrees superiorly and nasally. 60 degrees inferiorly"}, {'measure': 'Clinical Ophthalmological Test Scores', 'timeFrame': 'Week 64', 'description': "Humphrey tests - The Humphrey visual field test measures the entire area of peripheral vision that can be seen while the eye is focused on a central point. During this test, lights of varying intensities appear in different parts of the visual field while the patient's eye is focused on a certain spot. A normal visual field extends approximately 100° temporally (laterally), 60° nasally, 60° superiorly, and 70° inferiorly. A normal visual field measures about: 90 degrees temporally. 50 degrees superiorly and nasally. 60 degrees inferiorly"}, {'measure': 'Visual Perception Test Scores', 'timeFrame': 'Baseline', 'description': 'Ability to detect and discriminate different visual features - The participant is asked to indicate (via button press) whether the test stimulus matches the sample (left button), does not match the sample (right button), or there was no test stimulus (withhold response).'}, {'measure': 'Visual Perception Test Scores', 'timeFrame': 'Day 15', 'description': 'Ability to detect and discriminate different visual features - The participant is asked to indicate (via button press) whether the test stimulus matches the sample (left button), does not match the sample (right button), or there was no test stimulus (withhold response).'}, {'measure': 'Visual Perception Test Scores', 'timeFrame': 'Week 8', 'description': 'Ability to detect and discriminate different visual features - The participant is asked to indicate (via button press) whether the test stimulus matches the sample (left button), does not match the sample (right button), or there was no test stimulus (withhold response).'}, {'measure': 'Visual Perception Test Scores', 'timeFrame': 'Week 10', 'description': 'Ability to detect and discriminate different visual features - The participant is asked to indicate (via button press) whether the test stimulus matches the sample (left button), does not match the sample (right button), or there was no test stimulus (withhold response).'}, {'measure': 'Visual Perception Test Scores', 'timeFrame': 'Week 16', 'description': 'Ability to detect and discriminate different visual features - The participant is asked to indicate (via button press) whether the test stimulus matches the sample (left button), does not match the sample (right button), or there was no test stimulus (withhold response).'}, {'measure': 'Visual Perception Test Scores', 'timeFrame': 'Week 48', 'description': 'Ability to detect and discriminate different visual features - The participant is asked to indicate (via button press) whether the test stimulus matches the sample (left button), does not match the sample (right button), or there was no test stimulus (withhold response).'}, {'measure': 'Visual Perception Test Scores', 'timeFrame': 'Week 50', 'description': 'Ability to detect and discriminate different visual features - The participant is asked to indicate (via button press) whether the test stimulus matches the sample (left button), does not match the sample (right button), or there was no test stimulus (withhold response).'}, {'measure': 'Visual Perception Test Scores', 'timeFrame': 'Week 56', 'description': 'Ability to detect and discriminate different visual features - The participant is asked to indicate (via button press) whether the test stimulus matches the sample (left button), does not match the sample (right button), or there was no test stimulus (withhold response).'}, {'measure': 'Visual Perception Test Scores', 'timeFrame': 'Week 64', 'description': 'Ability to detect and discriminate different visual features - The participant is asked to indicate (via button press) whether the test stimulus matches the sample (left button), does not match the sample (right button), or there was no test stimulus (withhold response).'}, {'measure': 'Functional magnetic resonance imaging (fMRI) scans', 'timeFrame': 'Baseline', 'description': 'Used to measure functional lesion and assess changes - fMRI enables the detection of abnormalities of the brain, as well as the assessment of the normal functional anatomy of the brain, which cannot be accomplished with other imaging techniques.'}, {'measure': 'Functional magnetic resonance imaging (fMRI) scans', 'timeFrame': 'Day 15', 'description': 'Used to measure functional lesion and assess changes - fMRI enables the detection of abnormalities of the brain, as well as the assessment of the normal functional anatomy of the brain, which cannot be accomplished with other imaging techniques.'}, {'measure': 'Functional magnetic resonance imaging (fMRI) scans', 'timeFrame': 'Week 8', 'description': 'Used to measure functional lesion and assess changes - fMRI enables the detection of abnormalities of the brain, as well as the assessment of the normal functional anatomy of the brain, which cannot be accomplished with other imaging techniques.'}, {'measure': 'Functional magnetic resonance imaging (fMRI) scans', 'timeFrame': 'Week 10', 'description': 'Used to measure functional lesion and assess changes - fMRI enables the detection of abnormalities of the brain, as well as the assessment of the normal functional anatomy of the brain, which cannot be accomplished with other imaging techniques.'}, {'measure': 'Functional magnetic resonance imaging (fMRI) scans', 'timeFrame': 'Week 16', 'description': 'Used to measure functional lesion and assess changes - fMRI enables the detection of abnormalities of the brain, as well as the assessment of the normal functional anatomy of the brain, which cannot be accomplished with other imaging techniques.'}, {'measure': 'Functional magnetic resonance imaging (fMRI) scans', 'timeFrame': 'Week 48', 'description': 'Used to measure functional lesion and assess changes - fMRI enables the detection of abnormalities of the brain, as well as the assessment of the normal functional anatomy of the brain, which cannot be accomplished with other imaging techniques.'}, {'measure': 'Functional magnetic resonance imaging (fMRI) scans', 'timeFrame': 'Week 50', 'description': 'Used to measure functional lesion and assess changes - fMRI enables the detection of abnormalities of the brain, as well as the assessment of the normal functional anatomy of the brain, which cannot be accomplished with other imaging techniques.'}, {'measure': 'Functional magnetic resonance imaging (fMRI) scans', 'timeFrame': 'Week 56', 'description': 'Used to measure functional lesion and assess changes - fMRI enables the detection of abnormalities of the brain, as well as the assessment of the normal functional anatomy of the brain, which cannot be accomplished with other imaging techniques.'}, {'measure': 'Functional magnetic resonance imaging (fMRI) scans', 'timeFrame': 'Week 64', 'description': 'Used to measure functional lesion and assess changes - fMRI enables the detection of abnormalities of the brain, as well as the assessment of the normal functional anatomy of the brain, which cannot be accomplished with other imaging techniques.'}, {'measure': 'Quality of Life (QoL) Assessment', 'timeFrame': 'Baseline', 'description': 'The Veterans Affairs Low-Vision Visual Functioning Questionnaire-48 (VA-LV-VFQ-48) - A higher score on the VA LV VFQ-48 indicates better ability or less difficulty in performing activities'}, {'measure': 'Quality of Life (QoL) Assessment', 'timeFrame': 'Day 15', 'description': 'The Veterans Affairs Low-Vision Visual Functioning Questionnaire-48 (VA-LV-VFQ-48) - A higher score on the VA LV VFQ-48 indicates better ability or less difficulty in performing activities'}, {'measure': 'Quality of Life (QoL) Assessment', 'timeFrame': 'Week 8', 'description': 'The Veterans Affairs Low-Vision Visual Functioning Questionnaire-48 (VA-LV-VFQ-48) - A higher score on the VA LV VFQ-48 indicates better ability or less difficulty in performing activities'}, {'measure': 'Quality of Life (QoL) Assessment', 'timeFrame': 'Week 10', 'description': 'The Veterans Affairs Low-Vision Visual Functioning Questionnaire-48 (VA-LV-VFQ-48) - A higher score on the VA LV VFQ-48 indicates better ability or less difficulty in performing activities'}, {'measure': 'Quality of Life (QoL) Assessment', 'timeFrame': 'Week 16', 'description': 'The Veterans Affairs Low-Vision Visual Functioning Questionnaire-48 (VA-LV-VFQ-48) - A higher score on the VA LV VFQ-48 indicates better ability or less difficulty in performing activities'}, {'measure': 'Quality of Life (QoL) Assessment', 'timeFrame': 'Week 48', 'description': 'The Veterans Affairs Low-Vision Visual Functioning Questionnaire-48 (VA-LV-VFQ-48) - A higher score on the VA LV VFQ-48 indicates better ability or less difficulty in performing activities'}, {'measure': 'Quality of Life (QoL) Assessment', 'timeFrame': 'Week 50', 'description': 'The Veterans Affairs Low-Vision Visual Functioning Questionnaire-48 (VA-LV-VFQ-48) - A higher score on the VA LV VFQ-48 indicates better ability or less difficulty in performing activities'}, {'measure': 'Quality of Life (QoL) Assessment', 'timeFrame': 'Week 56', 'description': 'The Veterans Affairs Low-Vision Visual Functioning Questionnaire-48 (VA-LV-VFQ-48) - A higher score on the VA LV VFQ-48 indicates better ability or less difficulty in performing activities'}, {'measure': 'Quality of Life (QoL) Assessment', 'timeFrame': 'Week 64', 'description': 'The Veterans Affairs Low-Vision Visual Functioning Questionnaire-48 (VA-LV-VFQ-48) - A higher score on the VA LV VFQ-48 indicates better ability or less difficulty in performing activities'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['multisensory', 'visual perception', 'neurorehabilitation'], 'conditions': ['Hemianopia, Homonymous', 'Cortical Blindness, Unspecified Side of Brain']}, 'descriptionModule': {'briefSummary': 'This study seeks to determine the extent of the visual capabilities that can be restored in hemianopic stroke patients by a multisensory training technique and evaluate changes in the brain that the training induces. The effectiveness of the technique will be evaluated in two interventional contexts: patients whose blindness is long-standing and stable, and another in which intervention is as soon as possible after the stroke.', 'detailedDescription': 'The aims of the study are to:\n\n1\\. To identify the visual capabilities and neural circuits in stroke patients with stable hemianopia (\\>6 months) that recover after regular multisensory (vs. unisensory) training sessions. This involves:\n\n1A. Using clinical ophthalmological tests and visual perceptual tests to evaluate the visual capabilities that are recovered.\n\n1B. Determining whether the size or extent of cortical lesions are predictive of changes induced by the training technique, and tracking changes in the residual visual circuits using functional magnetic resonance imaging (fMRI).\n\n1C. Determining if the training-induced changes improve, persist, or degrade over time by re-assessment at a 12-month followup.\n\n2\\. Evaluate the effectiveness of an earlier (\\<1 month post-stroke) and more intense training intervention strategy using the above approach and comparing the outcomes in these two approaches.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age \\>= 18 years old\n* Homonymous hemianopia diagnosed and referred by a neurologist, confirmed with Humphrey test (Goldmann size V) on first visit. Hemianopia must have been evident for at least 6 months for inclusion in the first experiment and \\<1 month for inclusion in the second\n* Cognitively normal, defined as having normal activities of daily living OR has received a cognitive adjudication of normal through the Wake Forest University School of Medicine or equivalent within the past 12 months\n* MRI compatible\n* Has reliable transportation or is able to use transportation provided by the study\n* English speaking\n\nExclusion Criteria:\n\n* Current major medical problems that might independently affect cognition, vision, or interfere with ability to attend study visits. This includes pathology of the retina or optic nerve explanatory of blindness\n* Unable or unwilling to attend scheduled testing and training sessions, including the 12 month follow up\n* Current diagnosis of a major neurological disorder that could interfere with the ability to follow task instructions (Dementia, Parkinson's disease, etc.) or that may interfere with the rehabilitation paradigm (uncorrected asymmetric hearing loss, deafness, hemineglect)\n* Unwilling or unable to provide consent for study participation\n* Current stroke symptoms deemed exclusionary by a study physician. This will be reviewed on a case-by-case basis by a study physician to determine whether factors may affect study outcomes, aims, or integrity\n* Taking medication that could negatively influence safety during the intervention\n* Enrolled in another interventional research study \\<= 3 months prior to beginning this study\n* Self-reports regularly drinking \\> 14 alcoholic beverages a week or current illicit drug use"}, 'identificationModule': {'nctId': 'NCT05894434', 'briefTitle': 'Ameliorating Stroke-induced Hemianopia Via Multisensory Training', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Ameliorating Stroke-induced Hemianopia Via Multisensory Training', 'orgStudyIdInfo': {'id': 'IRB00093457'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Standard Intervention: Multisensory Training', 'description': 'Patients with stable hemianopia (\\>6 months) are given multisensory training', 'interventionNames': ['Behavioral: Multisensory Training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Intervention: Unisensory Training', 'description': 'Patients with stable hemianopia (\\>6 months) are given auditory training and crossover to multisensory training', 'interventionNames': ['Behavioral: Multisensory Training', 'Behavioral: Unisensory Training']}, {'type': 'EXPERIMENTAL', 'label': 'Early Intervention: Multisensory Training', 'description': 'Patients with early hemianopia (\\<1 months) are given multisensory training', 'interventionNames': ['Behavioral: Multisensory Training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Early Intervention: Unisensory Training', 'description': 'Patients with early hemianopia (\\<1 months) are given auditory training and crossover to multisensory training', 'interventionNames': ['Behavioral: Multisensory Training', 'Behavioral: Unisensory Training']}], 'interventions': [{'name': 'Multisensory Training', 'type': 'BEHAVIORAL', 'description': 'The procedure involves repeatedly presenting identical visual-auditory stimuli at a single location in the hemianopic field (initially at 45° of eccentricity along the azimuth) while the patient maintains central fixation (0°, 0°). The visual (a 500 ms flash) and auditory (500 ms broadband noise burst) stimuli are in spatial and temporal congruence.', 'armGroupLabels': ['Early Intervention: Multisensory Training', 'Early Intervention: Unisensory Training', 'Standard Intervention: Multisensory Training', 'Standard Intervention: Unisensory Training']}, {'name': 'Unisensory Training', 'type': 'BEHAVIORAL', 'description': 'The procedure involves repeatedly presenting identical auditory stimuli (500 ms broadband noise burst) at a single location in the hemianopic field (initially at 45° of eccentricity along the azimuth) while the patient maintains central fixation (0°, 0°).', 'armGroupLabels': ['Early Intervention: Unisensory Training', 'Standard Intervention: Unisensory Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'contacts': [{'name': 'Benjamin A Rowland, PhD', 'role': 'CONTACT', 'email': 'browland@wakehealth.edu', 'phone': '336-716-7096'}, {'name': 'Benjamin A Rowland, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Wake Forest University School of Medicine', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'centralContacts': [{'name': 'Benjamin A Rowland, PhD', 'role': 'CONTACT', 'email': 'browland@wakehealth.edu', 'phone': '336-716-7096'}], 'overallOfficials': [{'name': 'Benjamin A Rowland, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Published data from the project will be made available to other researchers via the NIMH NDA repository. This may or may not include IPD.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}