BrainPort V200 Device for Blindness

N/A

Waitlist Available

Led By Patricia Grant, M.S.

Research Sponsored by Wicab

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 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the BrainPort V200, a wearable device for people who are completely blind. It uses a camera to capture images and sends signals to the user's tongue, helping them feel visual information about their surroundings. The study aims to evaluate its safety and effectiveness in people who lost their vision due to injury. The BrainPort device enables blind people to perceive light, identify simple objects, recognize short words, localize simple objects, and detect motion and orientation of objects.

Eligible Conditions

Blindness

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To assess the efficacy of the BrainPort device as measured by an object recognition task (to demonstrate at least 35% of subjects achieve a success rate in object recognition exceeding that expected by chance alone)

To assess the safety of electrical stimulation on the tongue (to demonstrate no occurrence of a clinically significant device-related adverse event)

Other study objectives

Navigation task

Text identification task