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Visual Perceptual Learning for the Treatment of Visual Field Defect (VIVID)

Primary Purpose

Stroke, Visual Field Defect

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Visual perceptual learning
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Visual Field Defect, Visual perceptual learning, Brain connectivity

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Learning

Control

Arm Description

Visual perceptual learning (VPL) group

Control group

Outcomes

Primary Outcome Measures

Improvement of visual field scores in visual field defect areas
Improvement of mean deviation scores in defected areas by Humphrey 750i Field test

Secondary Outcome Measures

Performance of visual perceptual learning
Performance (scores) of visual perceptual learning
Connectivity changes in MRI
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
Improvement of mean deviation scores in whole visual field by Humphrey 750i Field test
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
Changes of visual evoked potential
Changes between baseline and 2 months after in half-field visual evoked potential (VEP) data

Full Information

First Posted
October 7, 2013
Last Updated
January 14, 2019
Sponsor
Asan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01959256
Brief Title
Visual Perceptual Learning for the Treatment of Visual Field Defect
Acronym
VIVID
Official Title
Visual Perceptual Learning for the Treatment of Visual Field Defect
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
October 2013 (Actual)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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: 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Visual Field Defect
Keywords
Stroke, Visual Field Defect, Visual perceptual learning, Brain connectivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Learning
Arm Type
Experimental
Arm Description
Visual perceptual learning (VPL) group
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control group
Intervention Type
Behavioral
Intervention Name(s)
Visual perceptual learning
Intervention Description
24 times of training for visual perceptual learning
Primary Outcome Measure Information:
Title
Improvement of visual field scores in visual field defect areas
Description
Improvement of mean deviation scores in defected areas by Humphrey 750i Field test
Time Frame
At 2 months (plus or minus 7 days) after baseline evaluation
Secondary Outcome Measure Information:
Title
Performance of visual perceptual learning
Description
Performance (scores) of visual perceptual learning
Time Frame
At 2 months (plus or minus 7 days) after baseline evaulation
Title
Connectivity changes in MRI
Description
Functional connectivity changes in resting-state functional MRI Structural connectivity changes in diffusion tensor imaging
Time Frame
Between baseline and 2 months (plus or minus 7 days) after
Title
Improvement of visual field score in whole visual field area
Description
Improvement of mean deviation scores in whole visual field by Humphrey 750i Field test
Time Frame
At 2 months (plus or minus 7days) after baseline evaluation
Title
Change of subjective visual function
Description
Change in Korean version of National Eye institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) Change of subjective visual field area
Time Frame
At 2 months (plus or minus 7days) after baseline evaluation
Title
Changes of visual evoked potential
Description
Changes between baseline and 2 months after in half-field visual evoked potential (VEP) data
Time Frame
Between baseline and 2 months (plus or minus 7 days) after

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong-Wha Kang, MD, PhD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Visual Perceptual Learning for the Treatment of Visual Field Defect

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