Visual Perceptual Learning Based Digital Therapeutics for Visual Field Defect After Stroke

NCT ID: NCT05525949

Last Updated: 2023-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-19

Study Completion Date

2023-11-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Visual Fields Hemianopsia Hemianopsia, Homonymous

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

VIVID Brain

VIVID Brain, 5 times a week for 12 weeks

Group Type EXPERIMENTAL

VIVID Brain

Intervention Type DEVICE

Participants receive visual perceptual training using the VIVID Brain software.

No-treatment Control

No-treatment is administered during control period.

Group Type OTHER

No-treatment Control

Intervention Type OTHER

No-treatment is administered during control period.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

VIVID Brain

Participants receive visual perceptual training using the VIVID Brain software.

Intervention Type DEVICE

No-treatment Control

No-treatment is administered during control period.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Nunaps Inc

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gyeong-Moon Kim, MD, PhD

Role: STUDY_CHAIR

Samsung Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Korea University Ansan Hospital

Ansan, , South Korea

Site Status

Hallym University Sacred Heart Hospital

Anyang, , South Korea

Site Status

Daejeon Eulji University Medical Center

Daejeon, , South Korea

Site Status

Inje University Ilsan Paik Hospital

Goyang, , South Korea

Site Status

Seoul National University Bundang Hospital

Seongnam, , South Korea

Site Status

Asan Medical Center

Seoul, , South Korea

Site Status

Chung-Ang University Hospital

Seoul, , South Korea

Site Status

Konkuk University Hospital

Seoul, , South Korea

Site Status

Samsung Medical Center

Seoul, , South Korea

Site Status

The Catholic University of Korea Seoul St. Mary's Hospital

Seoul, , South Korea

Site Status

The Catholic University of Korea Yeouido St. Mary's Hospital

Seoul, , South Korea

Site Status

Ulsan University Hospital

Ulsan, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 40388168 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NNS-VB-02

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

VIM+PTT MRgFUS for PD
NCT07044973 RECRUITING NA