Clinical trial NCT01959256: Visual Perceptual Learning for the Treatment of Visual Field Defect
Official title: Visual Perceptual Learning for the Treatment of Visual Field Defect
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Visual Field Defect
Keywords: Stroke
Visual Field Defect
Visual perceptual learning
Brain connectivity
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2013-10-09
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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).

Primary outcomes:
measure: Improvement of visual field scores in visual field defect areas
timeFrame: At 2 months (plus or minus 7 days) after baseline evaluation
Secondary outcomes:
measure: Performance of visual perceptual learning
timeFrame: At 2 months (plus or minus 7 days) after baseline evaulation
measure: Connectivity changes in MRI
timeFrame: Between baseline and 2 months (plus or minus 7 days) after
measure: Improvement of visual field score in whole visual field area
timeFrame: At 2 months (plus or minus 7days) after baseline evaluation
measure: Change of subjective visual function
timeFrame: At 2 months (plus or minus 7days) after baseline evaluation
measure: Changes of visual evoked potential
timeFrame: Between baseline and 2 months (plus or minus 7 days) after
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Dong-Wha Kang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: