Visual Fields HemianopsiaNCT05525949
Visual Perceptual Learning Based Digital Therapeutics for Visual Field Defect After Stroke
A study testing VIVID Brain in people with Visual Fields Hemianopsia and Hemianopsia, Homonymous, run by Nunaps Inc at 12 sites in South Korea.
Trial summary
This study evaluates the efficacy of visual perceptual learning for the treatment of visual field defect caused by brain disease. Half of participants will receive visual perceptual training using the VIVID Brain. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Visual Fields Hemianopsia, Hemianopsia, Homonymous
- What is being tested?
- VIVID Brain
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 12 sitesSouth Korea
- Study dates
- 19 Oct 2022to 8 Nov 2023
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 19 years and older
- At least 3 months after brain disease related to visual field defect
- Verified brain disease in visual pathway related to occipital lobe, parietal lobe, temporal lobe or etc. using CT or MRI
- Brain disease induced visual field defect
- Able to use the VR(Virtual Reality) device
- Able to use the app with a smart phone
- Patient/legally authorized representative has signed the informed consent form
Who cannot join
- Complete hemianopsia
- Epilepsy, photosensitivity, Parkinson's disease
- Bilateral visual field defect
- Hemispatial neglect
- Ophthalmologic disorder that may interfere the trial. (Ptosis of Eyelid, Corneal Opacity, Diabetic Retinopathy, Glaucoma, Macular Degeneration etc.)
- Inability to discontinue psychostimulants such as methylphenidate, modafinil, and amphetamine.
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- Candidate for carotid endarterectomy or stenting
- Received ophthalmologic surgery or laser surgery within 3 months, except for the cataract surgery
- Pregnant or breast feeding
- Participating in other clinical trial
- Any other condition that, in the opinion of the investigator, precludes participation in the trial
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
South Korea12 sites
Korea University Ansan Hospital
Ansan
Hallym University Sacred Heart Hospital
Anyang
Daejeon Eulji University Medical Center
Daejeon
Inje University Ilsan Paik Hospital
Goyang
Seoul National University Bundang Hospital
Seongnam
Asan Medical Center
Seoul
Chung-Ang University Hospital
Seoul
Konkuk University Hospital
Seoul
Samsung Medical Center
Seoul
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul
The Catholic University of Korea Yeouido St. Mary's Hospital
Seoul
Ulsan University Hospital
Ulsan
About this study
Official title: Treatment of Homonymous Visual Loss With Digital Therapeutics, VIVID Brain, Visual Perceptual Learning Device (HOGWAND Trial) : Multi Center, Randomized, Single-blind (Evaluator), Superiority Prove, Prospective Confirmatory Trial
This study evaluates the efficacy of visual perceptual learning for the treatment of visual field defect caused by brain disease. Half of participants will receive visual perceptual training using the VIVID Brain. The other half will not receive any training because there is no standard treatment for visual field defect caused by brain disease.
- Conditions
- Visual Fields Hemianopsia, Hemianopsia, Homonymous
- Being tested
- VIVID Brain, No-treatment Control
- Keywords
- Visual field defect, Visual perceptual learning, Humphrey visual field
- Medical subject headings
- Hemianopsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIVID BrainDevice
Participants receive visual perceptual training using the VIVID Brain software.
No-treatment ControlOther
No-treatment is administered during control period.
| Study group | Role | What they receive |
|---|---|---|
| VIVID Brain | Experimental | VIVID Brain, 5 times a week for 12 weeks Receives: Device: VIVID Brain |
| No-treatment Control | Other | No-treatment is administered during control period. Receives: Other: No-treatment Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
The sum of improved areas compared to baseline in the whole field
The sum of areas where sensitivity increased by more than 6 dB compared to baseline in the whole field measured by Humphrey visual field test.
The improved area ranges between 0 and 2,736 degree^2, of which larger area indicates better outcome.
Measured: 12 weeks
Secondary outcomes (3)
The sum of improved areas compared to baseline in the affected hemi-field
The sum of areas where sensitivity increased by more than 6 dB compared to baseline in the affected hemi-field measured by Humphrey visual field test.
Measured: 12 weeks
Changes in perimetric mean deviation relative to baseline in the whole field
Changes in perimetric mean deviation relative to baseline in the whole field measured by Humphrey visual field test.
Measured: 12 weeks
Changes in mean total deviation relative to baseline in the affected hemi-field
Changes in mean total deviation relative to baseline in the affected hemi-field measured by Humphrey visual field test.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start19 Oct 2022
- Primary completion11 Aug 2023
- Study completion8 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Visual Fields HemianopsiaStudies of the same condition, open and under way.
- 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
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nunaps Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gyeong-Moon Kim, MD, PhD, Study chair, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05525949
- Sponsor's protocol ID
- NNS-VB-02
- Status last verified
- Dec 2022
- First submitted
- 31 Aug 2022
- Last updated
- 13 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Namgung E, Kim BJ, Kwon JH, Han MK, Kim HY, Jung JM, Kim JG, Park KY, Koo J, Hong KS, Yu KH, Cho AH, Chang JY, Kwon SU, Lee BJ, Choi HG, Cho M, Kim GM, Kang DW. Personalized Visual Perceptual Learning Digital Therapy for Visual Field Defects Following Stroke: A Randomized Clinical Trial. JAMA Netw Open. 2025 May 1;8(5):e2511068. doi: 10.1001/jamanetworkopen.2025.11068.
PubMed 40388168
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Homonymous Visual Loss With Digital Therapeutics, VIVID Brain, Visual Perceptual Learning Device (HOGWAND Trial) : Multi Center, Randomized, Single-blind (Evaluator), Superiority Prove, Prospective Confirmatory Trial
- ClinicalTrials.gov ID
- NCT05525949
- Acronym / sponsor ID
- NNS-VB-02
- Conditions
- Visual Fields Hemianopsia, Hemianopsia, Homonymous
- Keywords
- Visual field defect, Visual perceptual learning, Humphrey visual field
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Nunaps IncIndustry (pharma, biotech, devices)
- Study start
- 19 Oct 2022 (actual)
- Primary completion
- 11 Aug 2023 (actual)
- Study completion
- 8 Nov 2023 (actual)
- First posted
- 2 Sep 2022 (actual)
- 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 evaluates the efficacy of visual perceptual learning for the treatment of visual field defect caused by brain disease. Half of participants will receive visual perceptual training using the VIVID Brain. The other half will not receive any training because there is no standard treatment for visual field defect caused by brain disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VIVID Brain | Experimental | Device: VIVID BrainVIVID Brain, 5 times a week for 12 weeks |
| No-treatment Control | Other | Other: No-treatment ControlNo-treatment is administered during control period. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 19 years and older
- At least 3 months after brain disease related to visual field defect
- Verified brain disease in visual pathway related to occipital lobe, parietal lobe, temporal lobe or etc. using CT or MRI
- Brain disease induced visual field defect
- Able to use the VR(Virtual Reality) device
Key exclusion criteria (11 listed)
- Complete hemianopsia
- Epilepsy, photosensitivity, Parkinson's disease
- Bilateral visual field defect
- Hemispatial neglect
- Ophthalmologic disorder that may interfere the trial. (Ptosis of Eyelid, Corneal Opacity, Diabetic Retinopathy, Glaucoma, Macular Degeneration etc.)
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 |
|---|---|---|
| VIVID BrainParticipants receive visual perceptual training using the VIVID Brain software. | Device | VIVID Brain |
| No-treatment ControlNo-treatment is administered during control period. | Other | No-treatment Control |
Primary outcome
The sum of improved areas compared to baseline in the whole field
Time frame: 12 weeks
The sum of areas where sensitivity increased by more than 6 dB compared to baseline in the whole field measured by Humphrey visual field test. The improved area ranges between 0 and 2,736 degree^2, of which larger area indicates better outcome.
3 secondary outcomes
The sum of improved areas compared to baseline in the affected hemi-field
Time frame: 12 weeks
Changes in perimetric mean deviation relative to baseline in the whole field
Time frame: 12 weeks
Changes in mean total deviation relative to baseline in the affected hemi-field
Time frame: 12 weeks
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 13 Nov 2023.
- Derived from this study: PubMed 40388168Namgung E, Kim BJ, Kwon JH, Han MK, Kim HY, Jung JM, Kim JG, Park KY, Koo J, Hong KS, Yu KH, Cho AH, Chang JY, Kwon SU, Lee BJ, Choi HG, Cho M, Kim GM, Kang DW. Personalized Visual Perceptual Learning Digital Therapy for Visual Field Defects Following Stroke: A Randomized Clinical Trial. JAMA Netw Open. 2025 May 1;8(5):e2511068. doi: 10.1001/jamanetworkopen.2025.11068.
Related trials for Visual Fields Hemianopsia
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Statistical Learning as a Novel Intervention for Cortical Blindness
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Anatomical and Functional Predictions of Blindsight Capabilities in Patients With Lateral Hemianopsia
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Effects of Optokinetic Stimulation Without a Reading Task in Patients With Hemianopic Alexia
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Effectiveness of a Visual Telerehabilitation Program on Visual Perception in Children, Adolescents and Young Adults With Hemianopsia Consecutive to a Brain Tumour
Hemianopsia, Virtual Reality
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.
Gyeong-Moon Kim, MD, PhD study chair
Samsung Medical Center
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VIVID Brain in people with Visual Fields Hemianopsia and Hemianopsia, Homonymous, run by Nunaps Inc at 12 sites 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 7 inclusion and 11 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 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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?
The sum of improved areas compared to baseline in the whole field (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05525949, which also lists 1 linked publication.
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 13 Nov 2023.