Visual Perceptual Learning for the Treatment of Visual Field Defect

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: January 2018

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

Interventions

  • Behavioral: Visual perceptual learning
    • 24 times of training for visual perceptual learning

Arms, Groups and Cohorts

  • Experimental: Learning
    • Visual perceptual learning (VPL) group
  • No Intervention: Control
    • Control group

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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).

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Asan Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dong-Wha Kang, MD, PhD – Asan Medical Center
  • Overall Official(s)
    • Dong-Wha Kang, MD, PhD, Principal Investigator, Asan Medical Center

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