Visual Perceptual Learning for the Treatment of Visual Field Defect

Study Overview
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Brief Summary
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This study will test the hypothesis whether visual field defect caused by chronic stroke could be improved by visual perceptual learning. The secondary hypothesis is that improvement of visual field defect would be accompanied by connectivity changes in visual networks. In addition, investigators will evaluate whether improvement of visual field defect could achieve improvement of subjective visual function.

Detailed Description
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Study design: A PROBE (Prospective, Randomized, Open-label, Blinded-endpoint) design Methods: Visual perceptual learning (VPL) group Visual perceptual learning (24 times for 2 months, 3 times per week) in visual field defect areas At baseline and post-VPL evaluations (2 months after): Structural & Functional MRIs, Visual field tests, Visual evoked potential, Visual cognitive tests, Subjective visual function questionnaires Control group At baseline and 2-months later: No VPL, Structural & Functional MRIs, Visual field tests, Visual evoked potential, Visual cognitive tests, Subjective visual function questionnaires Visual perceptual learning after 2-month follow-up evaluation (24 times for 2 months, 3 times per week) (The patients who were stratified by age (over 65 years old or not) and degree of visual field defect (quadrantanopia or complete hemianopia) will be randomly assigned into the learning and control group.) Investigations Improvement of visual field test scores between VPL group and control group Analysis of brain network changes in MRI data Correlation analysis of improvement of visual field defect and MRI data Correlation analysis of improvement of visual field defect and visual evoked potential (VEP) data Correlation analysis of improvement of visual field defect and neuropsychological data

Official Title
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Visual Perceptual Learning for the Treatment of Visual Field Defect

Conditions
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Stroke, Visual Field Defect

Intervention / Treatment
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* Behavioral: Visual perceptual learning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient has chronic stroke more than 6 months after onset. The patient has visual field defect (Quadrantanopia or Hemianopia). The patient has corrected eyesight 0.7 or above. Exclusion Criteria: The patient has contraindication to MRI scan. The patient has cognitive impairment (Mini-Mental Status Exam score <24). The patient has ophthalmologic diseases (e.g., glaucoma, cataract).

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Learning<br>Visual perceptual learning (VPL) group | Behavioral: Visual perceptual learning<br>* 24 times of training for visual perceptual learning<br>|
| No Intervention: Control<br>Control group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of visual field scores in visual field defect areas | Improvement of mean deviation scores in defected areas by Humphrey 750i Field test | At 2 months (plus or minus 7 days) after baseline evaluation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance of visual perceptual learning | Performance (scores) of visual perceptual learning | At 2 months (plus or minus 7 days) after baseline evaulation | 
| Connectivity changes in MRI | Functional connectivity changes in resting-state functional MRI Structural connectivity changes in diffusion tensor imaging | Between baseline and 2 months (plus or minus 7 days) after | 
| Improvement of visual field score in whole visual field area | Improvement of mean deviation scores in whole visual field by Humphrey 750i Field test | At 2 months (plus or minus 7days) after baseline evaluation | 
| Change of subjective visual function | Change in Korean version of National Eye institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) Change of subjective visual field area | At 2 months (plus or minus 7days) after baseline evaluation | 
| Changes of visual evoked potential | Changes between baseline and 2 months after in half-field visual evoked potential (VEP) data | Between baseline and 2 months (plus or minus 7 days) after | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Visual Field Defect, Visual perceptual learning, Brain connectivity