Visual Perceptual Learning for the Treatment of Visual Field Defect

Stroke Clinical Trial

— VIVID  

Official title:

Visual Perceptual Learning for the Treatment of Visual Field Defect

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01959256
• Other study ID #: VIVID
• Status: Completed
• Phase: N/A
• Start date: October 2013
• Est. completion date: January 2018

Study information

• Verified date: January 2019
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Stroke
• Visual Field Defect

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of visual field scores in visual field defect areas	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	Performance of visual perceptual learning	Performance (scores) of visual perceptual learning	At 2 months (plus or minus 7 days) after baseline evaulation
Secondary	Connectivity changes in MRI	Functional connectivity changes in resting-state functional MRI; Structural connectivity changes in diffusion tensor imaging	Between baseline and 2 months (plus or minus 7 days) after
Secondary	Improvement of visual field score in whole visual field area	Improvement of mean deviation scores in whole visual field by Humphrey 750i Field test	At 2 months (plus or minus 7days) after baseline evaluation
Secondary	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	At 2 months (plus or minus 7days) after baseline evaluation
Secondary	Changes of visual evoked potential	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