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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A - Blind | Experimental | 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. |
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| Group C - Control | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BrainPort | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Average Time to completion of obstacle path (over 25 trials) in seconds | To evaluate the usefulness of an artificial vision system called BrainPort® system in blind patients | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Average Number of errors during each trial (over 25 trials) | 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 | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Hertle, MD | Akron Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Akron Children's Hospital | Akron | Ohio | 44308 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10396626 | Background | Normann RA, Maynard EM, Rousche PJ, Warren DJ. A neural interface for a cortical vision prosthesis. Vision Res. 1999 Jul;39(15):2577-87. doi: 10.1016/s0042-6989(99)00040-1. | |
| 15337140 | Background | Chowdhury V, Morley JW, Coroneo MT. Surface stimulation of the brain with a prototype array for a visual cortex prosthesis. J Clin Neurosci. 2004 Sep;11(7):750-5. doi: 10.1016/j.jocn.2003.12.010. |
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| ID | Term |
|---|---|
| D001766 | Blindness |
| ID | Term |
|---|---|
| D014786 | Vision Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| 16076336 | Background | Chowdhury V, Morley JW, Coroneo MT. Stimulation of the retina with a multielectrode extraocular visual prosthesis. ANZ J Surg. 2005 Aug;75(8):697-704. doi: 10.1111/j.1445-2197.2005.03498.x. |
| Background | World Health Organization. Preventing blindness in children: report of WHO/IAPB scientific meeting. Geneva: WHO, 2000. (WHO/PBL/00.77.) |
| 15578200 | Background | Sachs HG, Schanze T, Wilms M, Rentzos A, Brunner U, Gekeler F, Hesse L. Subretinal implantation and testing of polyimide film electrodes in cats. Graefes Arch Clin Exp Ophthalmol. 2005 May;243(5):464-8. doi: 10.1007/s00417-004-1049-x. Epub 2004 Dec 1. |
| 16385646 | Background | Danilov Y, Tyler M. Brainport: an alternative input to the brain. J Integr Neurosci. 2005 Dec;4(4):537-50. doi: 10.1142/s0219635205000914. |
| 15634727 | Background | Ptito M, Moesgaard SM, Gjedde A, Kupers R. Cross-modal plasticity revealed by electrotactile stimulation of the tongue in the congenitally blind. Brain. 2005 Mar;128(Pt 3):606-14. doi: 10.1093/brain/awh380. Epub 2005 Jan 5. |
| Background | O'Shea, R. P., Roeber, U., & Bach, M. (2010). Evoked potentials: Vision. In E. B. Goldstein (Ed.), Encyclopedia of Perception (Vol. 1, pp. 399-400, xli). Los Angeles: Sage. ISBN 9781412940818 |
| D005128 |
| Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |