Ameliorating Stroke-induced Hemianopia Via Multisensory Training

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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°).

Первичные конечные точки

• Clinical Ophthalmological Test Scores [Срок оценки: Baseline]
• Clinical Ophthalmological Test Scores [Срок оценки: Day 15]
• Clinical Ophthalmological Test Scores [Срок оценки: Week 8]
• Clinical Ophthalmological Test Scores [Срок оценки: Week 10]
• Clinical Ophthalmological Test Scores [Срок оценки: Week 16]
• Clinical Ophthalmological Test Scores [Срок оценки: Week 48]
• Clinical Ophthalmological Test Scores [Срок оценки: Week 50]
• Clinical Ophthalmological Test Scores [Срок оценки: Week 56]
• Clinical Ophthalmological Test Scores [Срок оценки: Week 64]
• Visual Perception Test Scores [Срок оценки: Baseline]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Wake Forest University School of Medicine — Winston-Salem

Идентификаторы

NCT: NCT05894434 · IRB00093457

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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