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

Hemianopsia, Homonymous Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05525949
• Other study ID #: NNS-VB-02
• Status: Completed
• Phase: N/A
• Start date: October 19, 2022
• Est. completion date: November 8, 2023

Study information

• Verified date: December 2022
• Source: Nunaps Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The other half will not receive any training because there is no standard treatment for visual field defect caused by brain disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: November 8, 2023
• Est. primary completion date: August 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemianopsia
• Hemianopsia, Homonymous
• Visual Fields Hemianopsia

Intervention

Device:
• VIVID Brain
Participants receive visual perceptual training using the VIVID Brain software.

Other:
• No-treatment Control
No-treatment is administered during control period.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Nunaps Inc

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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