Visual Perceptual Learning for the Treatment of Visual Field Defect "VIVID"

Recruiting

Phase N/A Results N/A

Trial Description

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

Study design: A PROBE (Prospective, Randomized, Open-label, Blinded-endpoint) design
Methods:
1. Visual perceptual learning (VPL) group
1. Visual perceptual learning (24 times for 2 months, 3 times per week) in visual field defect areas
2. 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
2. Control group
1. At baseline and 2-months later: No VPL, Structural & Functional MRIs, Visual field tests, Visual evoked potential, Visual cognitive tests, Subjective visual function questionnaires
2. 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.)
3. Investigations
1. Improvement of visual field test scores between VPL group and control group
2. Analysis of brain network changes in MRI data
3. Correlation analysis of improvement of visual field defect and MRI data
4. Correlation analysis of improvement of visual field defect and visual evoked potential (VEP) data
5. Correlation analysis of improvement of visual field defect and neuropsychological data

Conditions

Interventions

  • Visual perceptual learning Behavioral
    Intervention Desc: 24 times of training for visual perceptual learning
    ARM 1: Kind: Experimental
    Label: Learning
    Description: Visual perceptual learning (VPL) group

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Improvement of visual field scores in visual field defect areas At 2 months (plus or minus 7 days) after baseline evaluation No
Secondary Performance of visual perceptual learning At 2 months (plus or minus 7 days) after baseline evaulation No
Secondary Connectivity changes in MRI Between baseline and 2 months (plus or minus 7 days) after No
Secondary Improvement of visual field score in whole visual field area At 2 months (plus or minus 7days) after baseline evaluation No
Secondary Change of subjective visual function At 2 months (plus or minus 7days) after baseline evaluation No
Secondary Changes of visual evoked potential Between baseline and 2 months (plus or minus 7 days) after No

Sponsors