Ameliorating Stroke-induced Hemianopia Via Multisensory Training

Wake Forest University (WFU)

Status: Begins enrollment in 1 month

Conditions: Cortical Blindness, Unspecified Side of Brain; Hemianopia, Homonymous

Treatments: Behavioral: Unisensory Training; Behavioral: Multisensory Training

Study type: Interventional

Funder types: Other

Identifiers

NCT05894434

IRB00093457

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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72 participants in 4 patient groups

Standard Intervention: Multisensory Training

Experimental group

Description:

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

Treatment:

Behavioral: Multisensory Training

Standard Intervention: Unisensory Training

Active Comparator group

Description:

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

Treatment:

Behavioral: Unisensory Training

Behavioral: Multisensory Training

Early Intervention: Multisensory Training

Experimental group

Description:

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

Treatment:

Behavioral: Multisensory Training

Early Intervention: Unisensory Training

Active Comparator group

Description:

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

Treatment:

Behavioral: Unisensory Training

Behavioral: Multisensory Training