Ameliorating Stroke-induced Hemianopia Via Multisensory Training

Not Applicable

Not yet recruiting

• Conditions: Hemianopia, Homonymous; Cortical Blindness, Unspecified Side of Brain
• Interventions: Behavioral: Multisensory Training; Behavioral: Unisensory Training

• Registration Number: NCT05894434
• Lead Sponsor: Wake Forest University Health Sciences

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-05-30
• Study First Submitted QC: 2023-05-30
• Study First Posted: 2023-06-08
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-03-30
• Study Start: 2025-09
• Primary Completion: 2027-03
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Standard Intervention: Multisensory Training	Multisensory Training	Patients with stable hemianopia (\>6 months) are given multisensory training
Standard Intervention: Unisensory Training	Multisensory Training	Patients with stable hemianopia (\>6 months) are given auditory training and crossover to multisensory training
Standard Intervention: Unisensory Training	Unisensory Training	Patients with stable hemianopia (\>6 months) are given auditory training and crossover to multisensory training
Early Intervention: Multisensory Training	Multisensory Training	Patients with early hemianopia (\<1 months) are given multisensory training
Early Intervention: Unisensory Training	Multisensory Training	Patients with early hemianopia (\<1 months) are given auditory training and crossover to multisensory training
Early Intervention: Unisensory Training	Unisensory Training	Patients with early hemianopia (\<1 months) are given auditory training and crossover to multisensory training

Primary Outcome Measures

Name	Time	Method
Visual Perception Test Scores	Week 64	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).
Quality of Life (QoL) Assessment	Week 64	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
Functional magnetic resonance imaging (fMRI) scans	Week 64	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.
Clinical Ophthalmological Test Scores	Week 64	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

Trial Locations

Locations (1)

Wake Forest University School of Medicine; 🇺🇸 Winston-Salem, North Carolina, United States