Visual Perceptual Learning Based Digital Therapeutics for Visual Field Defect After Stroke
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
1 other identifier
interventional
93
1 country
12
Brief 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. The other half will not receive any training because there is no standard treatment for visual field defect caused by brain disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2022
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2022
CompletedFirst Posted
Study publicly available on registry
September 2, 2022
CompletedStudy Start
First participant enrolled
October 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 11, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 8, 2023
CompletedNovember 13, 2023
December 1, 2022
10 months
August 31, 2022
November 9, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
12 weeks
Secondary Outcomes (3)
The sum of improved areas compared to baseline in the affected hemi-field
12 weeks
Changes in perimetric mean deviation relative to baseline in the whole field
12 weeks
Changes in mean total deviation relative to baseline in the affected hemi-field
12 weeks
Study Arms (2)
VIVID Brain
EXPERIMENTALVIVID Brain, 5 times a week for 12 weeks
No-treatment Control
OTHERNo-treatment is administered during control period.
Interventions
Participants receive visual perceptual training using the VIVID Brain software.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nunaps Inclead
Study Sites (12)
Korea University Ansan Hospital
Ansan, South Korea
Hallym University Sacred Heart Hospital
Anyang, South Korea
Daejeon Eulji University Medical Center
Daejeon, South Korea
Inje University Ilsan Paik Hospital
Goyang, South Korea
Seoul National University Bundang Hospital
Seongnam, South Korea
Asan Medical Center
Seoul, South Korea
Chung-Ang University Hospital
Seoul, South Korea
Konkuk University Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, South Korea
The Catholic University of Korea Yeouido St. Mary's Hospital
Seoul, South Korea
Ulsan University Hospital
Ulsan, South Korea
Related Publications (1)
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.
PMID: 40388168DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Gyeong-Moon Kim, MD, PhD
Samsung Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2022
First Posted
September 2, 2022
Study Start
October 19, 2022
Primary Completion
August 11, 2023
Study Completion
November 8, 2023
Last Updated
November 13, 2023
Record last verified: 2022-12