Ameliorating Stroke-induced Hemianopia Via Multisensory Training
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Multisensory Training, Unisensory Training.
- Who it may be relevant to
- Registry conditions: Hemianopia, Homonymous, Cortical Blindness, Unspecified Side of Brain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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. - 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°).
Primary outcome measures
- Clinical Ophthalmological Test Scores [Time frame: Baseline]
- Clinical Ophthalmological Test Scores [Time frame: Day 15]
- Clinical Ophthalmological Test Scores [Time frame: Week 8]
- Clinical Ophthalmological Test Scores [Time frame: Week 10]
- Clinical Ophthalmological Test Scores [Time frame: Week 16]
- Clinical Ophthalmological Test Scores [Time frame: Week 48]
- Clinical Ophthalmological Test Scores [Time frame: Week 50]
- Clinical Ophthalmological Test Scores [Time frame: Week 56]
- Clinical Ophthalmological Test Scores [Time frame: Week 64]
- Visual Perception Test Scores [Time frame: Baseline]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Wake Forest University School of Medicine — Winston-Salem
Identifiers
NCT: NCT05894434 · IRB00093457