Ameliorating Stroke-induced Hemianopia Via Multisensory Training

Hemianopia, Homonymous Clinical Trial

Official title:

Ameliorating Stroke-induced Hemianopia Via Multisensory Training

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05894434
• Other study ID #: IRB00093457
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2024
• Est. completion date: March 2029

Study information

• Verified date: April 2024
• Source: Wake Forest University Health Sciences
• Contact: Benjamin A Rowland, PhD
• Phone: 336-716-7096
• Email: browland[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

The aims of the study are to:

1. 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:

1A. Using clinical ophthalmological tests and visual perceptual tests to evaluate the visual capabilities that are recovered.

1B. 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).

1C. Determining if the training-induced changes improve, persist, or degrade over time by re-assessment at a 12-month followup.

2. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 72
• Est. completion date: March 2029
• Est. primary completion date: March 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age >= 18 years old

• 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

• 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

• MRI compatible

• Has reliable transportation or is able to use transportation provided by the study

• English speaking

Exclusion Criteria:

• 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

• Unable or unwilling to attend scheduled testing and training sessions, including the 12 month follow up

• 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)

• Unwilling or unable to provide consent for study participation

• 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

• Taking medication that could negatively influence safety during the intervention

• Enrolled in another interventional research study <= 3 months prior to beginning this study

• Self-reports regularly drinking > 14 alcoholic beverages a week or current illicit drug use

Related Conditions & MeSH terms

• Blindness
• Hemianopia, Homonymous
• Hemianopsia

Intervention

Behavioral:
• Multisensory Training
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.
• Unisensory Training
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°).

Locations

Country	Name	City	State
United States	Wake Forest University School of Medicine	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Ophthalmological Test Scores	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	Baseline
Primary	Clinical Ophthalmological Test Scores	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	Day 15
Primary	Clinical Ophthalmological Test Scores	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	Week 8
Primary	Clinical Ophthalmological Test Scores	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	Week 10
Primary	Clinical Ophthalmological Test Scores	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	Week 16
Primary	Clinical Ophthalmological Test Scores	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	Week 48
Primary	Clinical Ophthalmological Test Scores	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	Week 50
Primary	Clinical Ophthalmological Test Scores	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	Week 56
Primary	Clinical Ophthalmological Test Scores	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	Week 64
Primary	Visual Perception Test Scores	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).	Baseline
Primary	Visual Perception Test Scores	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).	Day 15
Primary	Visual Perception Test Scores	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).	Week 8
Primary	Visual Perception Test Scores	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).	Week 10
Primary	Visual Perception Test Scores	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).	Week 16
Primary	Visual Perception Test Scores	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).	Week 48
Primary	Visual Perception Test Scores	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).	Week 50
Primary	Visual Perception Test Scores	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).	Week 56
Primary	Visual Perception Test Scores	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).	Week 64
Primary	Functional magnetic resonance imaging (fMRI) scans	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.	Baseline
Primary	Functional magnetic resonance imaging (fMRI) scans	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.	Day 15
Primary	Functional magnetic resonance imaging (fMRI) scans	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.	Week 8
Primary	Functional magnetic resonance imaging (fMRI) scans	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.	Week 10
Primary	Functional magnetic resonance imaging (fMRI) scans	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.	Week 16
Primary	Functional magnetic resonance imaging (fMRI) scans	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.	Week 48
Primary	Functional magnetic resonance imaging (fMRI) scans	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.	Week 50
Primary	Functional magnetic resonance imaging (fMRI) scans	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.	Week 56
Primary	Functional magnetic resonance imaging (fMRI) scans	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.	Week 64
Primary	Quality of Life (QoL) Assessment	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	Baseline
Primary	Quality of Life (QoL) Assessment	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	Day 15
Primary	Quality of Life (QoL) Assessment	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	Week 8
Primary	Quality of Life (QoL) Assessment	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	Week 10
Primary	Quality of Life (QoL) Assessment	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	Week 16
Primary	Quality of Life (QoL) Assessment	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	Week 48
Primary	Quality of Life (QoL) Assessment	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	Week 50
Primary	Quality of Life (QoL) Assessment	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	Week 56
Primary	Quality of Life (QoL) Assessment	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	Week 64