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Assistive Communication Devices for Visual Impairment (VIS4ION Trial)
N/A
Waitlist Available
Led By John R Rizzo, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 6
Awards & highlights
VIS4ION Trial Summary
This trial will use software to combine information from newly embedded infrared, ultrasound, and stereo-camera-based sensors in a wearable vest with the aim of helping people who are blind or have low vision to navigate independently.
Who is the study for?
This trial is for individuals with varying levels of visual impairment. Participants should be able to perform tasks without significant cognitive dysfunction (scoring at least 24 on a mental status exam), have no major neurological illnesses or complicated medical conditions, and not have severe mobility restrictions such as needing walkers or wheelchairs.Check my eligibility
What is being tested?
The study tests the VIS4ION System, which includes a sensor-embedded vest, a haptic feedback belt, smartphone connectivity, and bone conduction headset. It aims to improve navigation for visually impaired people by providing real-time spatial information through tactile and auditory means.See study design
What are the potential side effects?
Since this trial involves assistive devices rather than medications, traditional side effects are not expected. However, participants may experience discomfort from wearing the equipment or challenges in adapting to the sensory feedback provided.
VIS4ION Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 6
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Path Length
Percentage of Correct Responses by Feedback Devices
Success Rate
+1 moreSecondary outcome measures
Change in International Physical Activity Questionnaire (IPAQ) Score
Change in Visual Functioning Questionnaire - 25 (VFQ-25) Score
Change in World Health Organization Quality of Life (WHOQOL)-BREF Score
VIS4ION Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Visually impairedExperimental Treatment1 Intervention
Visually impaired subjects will provide continuity across iterations of the testing, allowing for direct comparisons of responses within an individual for a single behavioral measure across different iterations of the device architecture and output configuration.
Group II: Thailand Site - Group A: Assistive Mode then Passive ModeExperimental Treatment1 Intervention
During the first 15 days, group A will go through an assistive mode and then a passive mode for the next 15 days
Group III: Healthy controlsActive Control1 Intervention
Healthy (naive) subjects invaluable insights as well as a range of body types, cognitive abilities, and other idiosyncrasies that will keep our design and testing process from tailoring the device to a small set of individuals rather than the broader population.
Group IV: Thailand Site - Group B: Passive Mode then Assistive ModeActive Control1 Intervention
Group B will go through a passive mode for the first 15 days and then an assistive mode for the second half of the month
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Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,367 Previous Clinical Trials
839,601 Total Patients Enrolled
1 Trials studying Visual Impairment
98 Patients Enrolled for Visual Impairment
John R Rizzo, MDPrincipal InvestigatorNYU Langone Health
2 Previous Clinical Trials
144 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have significant problems with memory and thinking, as measured by a specific test.I have a visual impairment.I use a walker or wheelchair due to significant mobility issues.I have a history of neurological illness or complex medical conditions.
Research Study Groups:
This trial has the following groups:- Group 1: Visually impaired
- Group 2: Healthy controls
- Group 3: Thailand Site - Group A: Assistive Mode then Passive Mode
- Group 4: Thailand Site - Group B: Passive Mode then Assistive Mode
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What requirements must be met for someone to participate in this clinical study?
"This research seeks 120 individuals aged 18-80 who are diagnosed with micropsia. Furthermore, participants must have varying levels and causes of visual impairments."
Answered by AI
Are there any openings in this trial for individuals to join?
"At present, the information on clinicaltrials.gov displays that this trial is not enrolling any more individuals. The study was initially posted in July of 2017 and last updated in October of 2022. Nonetheless, there are still 52 other trials currently accepting patients into their programmes."
Answered by AI
Are participants aged over 20 being sought by this investigation?
"This trial is seeking participants that are over the age of consent and under 80 years old."
Answered by AI
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