Clinical Trial: Continued Study of Artificial Vision: Evaluation of the BrainPort® System and Investigation of Visual Ambulation

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Continued Study of Artificial Vision: Evaluation of the BrainPort® System and Investigation of Visual Ambulation

Brief Summary: The purpose of this study is to evaluate the use of an artificial vision system called Brainport system in blind patients To investigate visual, and oculomotor (eye motion) mechanisms involved in the use of the Brainport system.

Detailed Summary:

The prevalence of blindness in the US adult population is 0.8% and ranges from about 3/10000 to 15/10000 in children. Data from world health organization show that about 500,000 children become blind each year. The annual cost of blindness to the federal government is $4 billion and the cost of a lifetime of support and unpaid taxes for a blind person is about $1 million.

There is a need to restore vision for blind patients. Research on vision restoration develops fast. There are multiple types of approaches toward producing useful artificial vision. One of them directly sends images from a video camera to the visual cortex via an electrode array that is intracranially placed on the visual cortex of blind patients. Another one surgically places an electrode array beneath the retina for patients whose optic nerves are still healthy. Both of them require major surgery and have high risks, and neither is available for routine clinical application.

The one that is non-invasive and easy to use is called the BrainPort® system. The BrainPort® system is manufactured by Wicab, Inc. It is commercially available and affordable to any consumer. This system is a novel, bionic, non-invasive, vision bypass system that conveys environment images from a spectacle-frame-mounted video-camera to the brain via an electro-tactile tongue array. The electro-tactile stimulation delivered by the tongue-array placed on the tongue allows users to interpret the images of objects in their camera's visual field.


Sponsor: Akron Children's Hospital

Current Primary Outcome: Average Time to completion of obstacle path (over 25 trials) in seconds [ Time Frame: 1 month ]

To evaluate the usefulness of an artificial vision system called BrainPort® system in blind patients


Original Primary Outcome: Same as current

Current Secondary Outcome: Average Number of errors during each trial (over 25 trials) [ Time Frame: 1 month ]

To investigate the visual mechanisms underlying how the visual sensory system is involved in information processing in the presence of tongue stimulation using sensory and visually evoked potentials


Original Secondary Outcome: Same as current

Information By: Akron Children's Hospital

Dates:
Date Received: December 23, 2015
Date Started: October 2011
Date Completion: September 2017
Last Updated: December 30, 2015
Last Verified: December 2015