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

Akron Children's Hospital

Status: Completed

Conditions: Blindness

Treatments: Device: BrainPort

Study type: Interventional

Funder types: Other

Identifiers

NCT02643238

111009

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 7 patients

Sex: All

Ages: 10 to 24 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Less than 25 years of age and be able to cooperate for full study protocol
• Have a clinical diagnosis of blindness (light perception or worse), or 20/20 vision corrected or otherwise.
• Have completed a complete ophthalmic evaluation.
• Patients recruited must be able to undergo the training to use the BrainPort® system.
• Sign informed consent (family) or assent (patient).

Exclusion criteria

• Have any neurologic disease, developmental delay, congenital genetic syndromes, congenital organ malformation, malformation syndromes or metabolic disease.
• Be on any medications known to affect the visual system

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7 participants in 2 patient groups

Group A - Blind

Experimental group

Description:

Subjects will be trained to ambulate through a 40-foot obstacle course by the occupational therapy colleagues at Akron Children's Hospital after which they will be scored on their performance while using the BrainPort® system.

Treatment:

Device: BrainPort

Group C - Control

Active Comparator group

Description:

Subjects will be trained to ambulate through a 40-foot obstacle course by the occupational therapy colleagues at Akron Children's Hospital after which they will be scored on their performance while using the BrainPort® system.

Treatment:

Device: BrainPort