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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01959256
Other study ID # VIVID
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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).

Study Design


Related Conditions & MeSH terms


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
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