StrokeVIVIDNCT01959256
Visual Perceptual Learning for the Treatment of Visual Field Defect
A study testing Visual perceptual learning in people with Stroke and Visual Field Defect, run by Asan Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Stroke, Visual Field Defect
- What is being tested?
- Visual perceptual learning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2013to Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient has chronic stroke more than 6 months after onset.
- The patient has visual field defect (Quadrantanopia or Hemianopia).
- The patient has corrected eyesight 0.7 or above.
Who cannot join
- The patient has contraindication to MRI scan.
- The patient has cognitive impairment (Mini-Mental Status Exam score <24).
- The patient has ophthalmologic diseases (e.g., glaucoma, cataract).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Study design: A PROBE (Prospective, Randomized, Open-label, Blinded-endpoint) design
Methods:
- Visual perceptual learning (VPL) group
- Visual perceptual learning (24 times for 2 months, 3 times per week) in visual field defect areas
- 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
- Control group
- At baseline and 2-months later: No VPL, Structural \& Functional MRIs, Visual field tests, Visual evoked potential, Visual cognitive tests, Subjective visual function questionnaires
- 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.)
- Investigations
- Improvement of visual field test scores between VPL group and control group
- Analysis of brain network changes in MRI data
- Correlation analysis of improvement of visual field defect and MRI data
- Correlation analysis of improvement of visual field defect and visual evoked potential (VEP) data
- Correlation analysis of improvement of visual field defect and neuropsychological data
- Conditions
- Stroke, Visual Field Defect
- Being tested
- Visual perceptual learning
- Keywords
- Stroke, Visual Field Defect, Visual perceptual learning, Brain connectivity
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual perceptual learningBehavioural
24 times of training for visual perceptual learning
| Study group | Role | What they receive |
|---|---|---|
| Learning | Experimental | Visual perceptual learning (VPL) group Receives: Behavioral: Visual perceptual learning |
| Control | No intervention | Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of visual field scores in visual field defect areas
Improvement of mean deviation scores in defected areas by Humphrey 750i Field test
Measured: At 2 months (plus or minus 7 days) after baseline evaluation
Secondary outcomes (5)
Performance of visual perceptual learning
Performance (scores) of visual perceptual learning
Measured: At 2 months (plus or minus 7 days) after baseline evaulation
Connectivity changes in MRI
- Functional connectivity changes in resting-state functional MRI
- Structural connectivity changes in diffusion tensor imaging
Measured: Between baseline and 2 months (plus or minus 7 days) after
Improvement of visual field score in whole visual field area
Improvement of mean deviation scores in whole visual field by Humphrey 750i Field test
Measured: At 2 months (plus or minus 7days) after baseline evaluation
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
Measured: At 2 months (plus or minus 7days) after baseline evaluation
Changes of visual evoked potential
Changes between baseline and 2 months after in half-field visual evoked potential (VEP) data
Measured: Between baseline and 2 months (plus or minus 7 days) after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong-Wha Kang, Asan Medical Center
- Investigators
- Dong-Wha Kang, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01959256
- Sponsor's protocol ID
- VIVID
- Acronym
- VIVID
- Status last verified
- Jan 2019
- First submitted
- 7 Oct 2013
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Perceptual Learning for the Treatment of Visual Field Defect
- ClinicalTrials.gov ID
- NCT01959256
- Acronym / sponsor ID
- VIVID / VIVID
- Conditions
- Stroke, Visual Field Defect
- Keywords
- Stroke, Visual Field Defect, Visual perceptual learning, Brain connectivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Oct 2013 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 9 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Visual perceptual learning (VPL) group
- Visual perceptual learning (24 times for 2 months, 3 times per week) in visual field defect areas
- 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
- Control group
- At baseline and 2-months later: No VPL, Structural \& Functional MRIs, Visual field tests, Visual evoked potential, Visual cognitive tests, Subjective visual function questionnaires
- 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.)
- Investigations
- Improvement of visual field test scores between VPL group and control group
- Analysis of brain network changes in MRI data
- Correlation analysis of improvement of visual field defect and MRI data
- Correlation analysis of improvement of visual field defect and visual evoked potential (VEP) data
- Correlation analysis of improvement of visual field defect and neuropsychological data
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Learning | Experimental | Behavioral: Visual perceptual learningVisual perceptual learning (VPL) group |
| Control | No intervention | –Control group |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The patient has chronic stroke more than 6 months after onset.
- The patient has visual field defect (Quadrantanopia or Hemianopia).
- The patient has corrected eyesight 0.7 or above.
Key exclusion criteria (3 listed)
- The patient has contraindication to MRI scan.
- The patient has cognitive impairment (Mini-Mental Status Exam score <24).
- The patient has ophthalmologic diseases (e.g., glaucoma, cataract).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visual perceptual learning24 times of training for visual perceptual learning | Behavioural | Learning |
Primary outcome
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
5 secondary outcomes
Performance of visual perceptual learning
Time frame: 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
Improvement of visual field score in whole visual field area
Time frame: 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
Changes of visual evoked potential
Time frame: Between baseline and 2 months (plus or minus 7 days) after
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dong-Wha Kang, MD, PhD principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual perceptual learning in people with Stroke and Visual Field Defect, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of visual field scores in visual field defect areas (time frame: At 2 months (plus or minus 7 days) after baseline evaluation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2019.