NCT02393118

A Study to Evaluate the BrainPort Vision Device in Individuals Blinded by Traumatic Injury

Safety and Efficacy of the BrainPort V200 Device in Individuals Blinded by Traumatic Injury

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Wicab · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The BrainPort V200 Device is a wearable, non-surgical, prosthetic device intended for people who are profoundly blind. The BrainPort V200 translates images captured by a digital camera into electro-tactile stimulation presented on the user's tongue to perceive shape, size, location, and motion of objects within the environment. The purpose of this study is to evaluate the safety and functional performance of the BrainPort V200 device in individuals who have been medically documented as blind, light perception or worse, due to a traumatic injury (cortical or ocular).

Conditions

• Blindness

Interventions

Type	Name	Description
DEVICE	BrainPort V200 Device	Training in clinic on use of the device for 2-3 days (10 hours) followed by in-home use for a minimum of 300 minutes per month over 12 months.

Timeline

• Start date: 2014-09-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2015-03-19
• Last updated: 2016-03-02

Locations

3 sites across 1 country: United States