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

NCT ID: NCT02643238

Last Updated: 2022-11-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2022-05-31

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 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.

Conditions

Blindness

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Group A - Blind

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.

Group Type: EXPERIMENTAL

BrainPort

Intervention Type: 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

Group C - Control

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.

Group Type: ACTIVE_COMPARATOR

BrainPort

Intervention Type: 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

Interventions

BrainPort

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Akron Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Hertle, MD

Role: PRINCIPAL_INVESTIGATOR

Akron Children's Hospital

Locations

Akron Children's Hospital

Akron, Ohio, United States

Countries

United States

References

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Reference Type: BACKGROUND

PMID: 10396626 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 15337140 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16076336 (View on PubMed)

World Health Organization. Preventing blindness in children: report of WHO/IAPB scientific meeting. Geneva: WHO, 2000. (WHO/PBL/00.77.)

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 15578200 (View on PubMed)

Danilov Y, Tyler M. Brainport: an alternative input to the brain. J Integr Neurosci. 2005 Dec;4(4):537-50. doi: 10.1142/s0219635205000914.

Reference Type: BACKGROUND

PMID: 16385646 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15634727 (View on PubMed)

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

Reference Type: BACKGROUND

Other Identifiers

111009

Identifier Type: -

Identifier Source: org_study_id