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

January 14, 2019 updated by: Dong-Wha Kang, Asan Medical Center
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control
Control group
EXPERIMENTAL: Learning
Visual perceptual learning (VPL) group
Behavioral: Visual perceptual learning
24 times of training for visual perceptual learning

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: At 2 months (plus or minus 7 days) after baseline evaulation
Performance (scores) of visual perceptual learning
At 2 months (plus or minus 7 days) after baseline evaulation
Connectivity changes in MRI
Time Frame: Between baseline and 2 months (plus or minus 7 days) after
  1. Functional connectivity changes in resting-state functional MRI
  2. 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
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
At 2 months (plus or minus 7days) after baseline evaluation
Change of subjective visual function
Time Frame: At 2 months (plus or minus 7days) after baseline evaluation
  1. Change in Korean version of National Eye institute Visual Functioning Questionnaire-25 (NEI-VFQ-25)
  2. Change of subjective visual field area
At 2 months (plus or minus 7days) after baseline evaluation
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
Between baseline and 2 months (plus or minus 7 days) after

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2013

Primary Completion (ACTUAL)

January 1, 2018

Study Completion (ACTUAL)

January 1, 2018

Study Registration Dates

First Submitted

October 7, 2013

First Submitted That Met QC Criteria

October 8, 2013

First Posted (ESTIMATE)

October 9, 2013

Study Record Updates

Last Update Posted (ACTUAL)

January 16, 2019

Last Update Submitted That Met QC Criteria

January 14, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VIVID

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on Visual perceptual learning

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bulgaria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe