Safety and Efficacy of the BrainPort V100 Device in Individuals Blinded by Traumatic Injury

Purpose There is an immediate need for non-invasive therapy to restore functional abilities of persons blinded by traumatic injury, including Veterans injured in combat. The BrainPort registered trademark V200 enables perception of visual information using the tongue as a substitute for the eye. The purpose of this study was to investigate the impact of the BrainPort V200 on real-world functional task performance in persons who are profoundly blind no better than light perception due to traumatic injury. Methods Twenty-two subjects blinded by traumatic injury were enrolled. Subjects received ten hours of device training prior to independent home use for 12 months. Subjects were assessed at baseline, post-training and quarterly for a year on real-world functional performance in the following skill areas object recognition 10 trials, word identification 10 trials, and orientation and mobility skills passfail. Results None of the subjects could complete any of the functional tasks at baseline without the device. After using the device independently at home for one year all subjects successfully completed the object recognition tasks and could recognize a doorway in a room, 41 percent could read at least 6 out of 10 words, 71 percent could identify a window, 94 percent followed a line without veering off, 71 percent avoided obstacles, 71 percent walked through a doorway without collisions, 50 percent identified a window, and 41 percent of subjects could identify a sign in a hallway. Subjects demonstrated success immediately following training and performance rates were either consistent or improved after one year of device use in the home.