Clinical trial NCT05894434: Ameliorating Stroke-induced Hemianopia Via Multisensory Training
Official title: Ameliorating Stroke-induced Hemianopia Via Multisensory Training
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hemianopia, Homonymous
Cortical Blindness, Unspecified Side of Brain
Keywords: multisensory
visual perception
neurorehabilitation
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2023-06-08
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 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 purpose: TREATMENT

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.

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

Primary outcomes:
measure: Clinical Ophthalmological Test Scores
timeFrame: Baseline
measure: Clinical Ophthalmological Test Scores
timeFrame: Day 15
measure: Clinical Ophthalmological Test Scores
timeFrame: Week 8
measure: Clinical Ophthalmological Test Scores
timeFrame: Week 10
measure: Clinical Ophthalmological Test Scores
timeFrame: Week 16
measure: Clinical Ophthalmological Test Scores
timeFrame: Week 48
measure: Clinical Ophthalmological Test Scores
timeFrame: Week 50
measure: Clinical Ophthalmological Test Scores
timeFrame: Week 56
measure: Clinical Ophthalmological Test Scores
timeFrame: Week 64
measure: Visual Perception Test Scores
timeFrame: Baseline
measure: Visual Perception Test Scores
timeFrame: Day 15
measure: Visual Perception Test Scores
timeFrame: Week 8
measure: Visual Perception Test Scores
timeFrame: Week 10
measure: Visual Perception Test Scores
timeFrame: Week 16
measure: Visual Perception Test Scores
timeFrame: Week 48
measure: Visual Perception Test Scores
timeFrame: Week 50
measure: Visual Perception Test Scores
timeFrame: Week 56
measure: Visual Perception Test Scores
timeFrame: Week 64
measure: Functional magnetic resonance imaging (fMRI) scans
timeFrame: Baseline
measure: Functional magnetic resonance imaging (fMRI) scans
timeFrame: Day 15
measure: Functional magnetic resonance imaging (fMRI) scans
timeFrame: Week 8
measure: Functional magnetic resonance imaging (fMRI) scans
timeFrame: Week 10
measure: Functional magnetic resonance imaging (fMRI) scans
timeFrame: Week 16
measure: Functional magnetic resonance imaging (fMRI) scans
timeFrame: Week 48
measure: Functional magnetic resonance imaging (fMRI) scans
timeFrame: Week 50
measure: Functional magnetic resonance imaging (fMRI) scans
timeFrame: Week 56
measure: Functional magnetic resonance imaging (fMRI) scans
timeFrame: Week 64
measure: Quality of Life (QoL) Assessment
timeFrame: Baseline
measure: Quality of Life (QoL) Assessment
timeFrame: Day 15
measure: Quality of Life (QoL) Assessment
timeFrame: Week 8
measure: Quality of Life (QoL) Assessment
timeFrame: Week 10
measure: Quality of Life (QoL) Assessment
timeFrame: Week 16
measure: Quality of Life (QoL) Assessment
timeFrame: Week 48
measure: Quality of Life (QoL) Assessment
timeFrame: Week 50
measure: Quality of Life (QoL) Assessment
timeFrame: Week 56
measure: Quality of Life (QoL) Assessment
timeFrame: Week 64
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University School of Medicine
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Benjamin A Rowland, PhD
role: PRINCIPAL_INVESTIGATOR
References: