Visual Perceptual Learning for the Treatment of Visual Field Defect

NCT ID: NCT01959256

Last Updated: 2019-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2018-01-31

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:

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

Stroke; Visual Field Defect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Learning

Visual perceptual learning (VPL) group

Group Type: EXPERIMENTAL

Visual perceptual learning

Intervention Type: BEHAVIORAL

24 times of training for visual perceptual learning

Control

Control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Visual perceptual learning

24 times of training for visual perceptual learning

Intervention Type: BEHAVIORAL

Eligibility 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).

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Dong-Wha Kang

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dong-Wha Kang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Asan Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

VIVID

Identifier Type: -

Identifier Source: org_study_id