Ameliorating Stroke-induced Hemianopia Via Multisensory Training

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-04-30

Study Completion Date

2027-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hemianopia, Homonymous Cortical Blindness, Unspecified Side of Brain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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Standard Intervention: Multisensory Training

Patients with stable hemianopia (\>6 months) are given multisensory training

Group Type EXPERIMENTAL

Multisensory Training

Intervention Type BEHAVIORAL

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.

Standard Intervention: Unisensory Training

Patients with stable hemianopia (\>6 months) are given auditory training and crossover to multisensory training

Group Type ACTIVE_COMPARATOR

Multisensory Training

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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°).

Early Intervention: Multisensory Training

Patients with early hemianopia (\<1 months) are given multisensory training

Group Type EXPERIMENTAL

Multisensory Training

Intervention Type BEHAVIORAL

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.

Early Intervention: Unisensory Training

Patients with early hemianopia (\<1 months) are given auditory training and crossover to multisensory training

Group Type ACTIVE_COMPARATOR

Multisensory Training

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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°).

Interventions

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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.

Intervention Type BEHAVIORAL

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°).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No