Visual Perceptual Learning for the Treatment of Visual Field Defect
Keywords
Abstract
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
Dates
| Last Verified: | 12/31/2018 |
| First Submitted: | 10/06/2013 |
| Estimated Enrollment Submitted: | 10/07/2013 |
| First Posted: | 10/08/2013 |
| Last Update Submitted: | 01/13/2019 |
| Last Update Posted: | 01/15/2019 |
| Actual Study Start Date: | 09/30/2013 |
| Estimated Primary Completion Date: | 12/31/2017 |
| Estimated Study Completion Date: | 12/31/2017 |
Condition or disease
Intervention/treatment
Behavioral: Learning
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: Learning Visual perceptual learning (VPL) group | Behavioral: Learning 24 times of training for visual perceptual learning |
| No Intervention: Control Control group |
Eligibility Criteria
| Ages Eligible for Study | 20 Years To 20 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: 1. The patient has chronic stroke more than 6 months after onset. 2. The patient has visual field defect (Quadrantanopia or Hemianopia). 3. The patient has corrected eyesight 0.7 or above. Exclusion Criteria: 1. The patient has contraindication to MRI scan. 2. The patient has cognitive impairment (Mini-Mental Status Exam score <24). 3. The patient has ophthalmologic diseases (e.g., glaucoma, cataract). |
Outcome
Primary Outcome Measures
1. Improvement of visual field scores in visual field defect areas [At 2 months (plus or minus 7 days) after baseline evaluation]
Secondary Outcome Measures
1. Performance of visual perceptual learning [At 2 months (plus or minus 7 days) after baseline evaulation]
2. Connectivity changes in MRI [Between baseline and 2 months (plus or minus 7 days) after]
3. Improvement of visual field score in whole visual field area [At 2 months (plus or minus 7days) after baseline evaluation]
4. Change of subjective visual function [At 2 months (plus or minus 7days) after baseline evaluation]
5. Changes of visual evoked potential [Between baseline and 2 months (plus or minus 7 days) after]
