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

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 Overview

• Status: Active, not recruiting
• Conditions: Visual Fields Hemianopsia; Hemianopsia, Homonymous
• Intervention / Treatment: Device: VIVID Brain; Other: No-treatment Control

• Study Type: Interventional
• Enrollment (Estimated): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Ansan, Korea, Republic of
    • Korea University Ansan Hospital
  • Anyang, Korea, Republic of
    • Hallym University Sacred Heart Hospital
  • Daejeon, Korea, Republic of
    • Daejeon Eulji University Medical Center
  • Goyang, Korea, Republic of
    • Inje University Ilsan Paik Hospital
  • Seongnam, Korea, Republic of
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • Samsung Medical Center
  • Seoul, Korea, Republic of
    • The Catholic University of Korea Seoul St. Mary'S Hospital
  • Seoul, Korea, Republic of
    • Chung-Ang University Hospital
  • Seoul, Korea, Republic of
    • Konkuk University Hospital
  • Seoul, Korea, Republic of
    • The Catholic University of Korea Yeouido St. Mary's Hospital
  • Ulsan, Korea, Republic of
    • Ulsan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VIVID Brain; VIVID Brain, 5 times a week for 12 weeks	Device: VIVID Brain; Participants receive visual perceptual training using the VIVID Brain software.
Other: No-treatment Control; No-treatment is administered during control period.	Other: No-treatment Control; No-treatment is administered during control period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	12 weeks

Collaborators and Investigators

• Sponsor: Nunaps Inc
• Investigators: Study Chair: Gyeong-Moon Kim, MD, PhD, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2022
• Primary Completion (Actual): August 11, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: August 31, 2022
• First Submitted That Met QC Criteria: August 31, 2022
• First Posted (Actual): September 2, 2022

Study Record Updates

• Last Update Posted (Actual): October 5, 2023
• Last Update Submitted That Met QC Criteria: October 4, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Visual field defect; Humphrey visual field; Visual perceptual learning
• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Sensation Disorders; Vision Disorders; Blindness; Hemianopsia
• Other Study ID Numbers: NNS-VB-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No