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

Primary Purpose

Blindness

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BrainPort
Sponsored by
Akron Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Blindness

Eligibility Criteria

10 Years - 24 Years (Child, Adult)All SexesAccepts 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

Sites / Locations

  • Akron Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A - Blind

Group C - Control

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 23, 2015
Last Updated
November 14, 2022
Sponsor
Akron Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02643238
Brief Title
Continued Study of Artificial Vision: Evaluation of the BrainPort® System and Investigation of Visual Ambulation
Acronym
BrainPort
Official Title
Continued Study of Artificial Vision: Evaluation of the BrainPort® System and Investigation of Visual Ambulation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
October 2011 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
May 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Akron Children's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blindness

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A - Blind
Arm Type
Experimental
Arm 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.
Arm Title
Group C - Control
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
BrainPort
Intervention Description
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
Primary Outcome Measure Information:
Title
Average Time to completion of obstacle path (over 25 trials) in seconds
Description
To evaluate the usefulness of an artificial vision system called BrainPort® system in blind patients
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Average Number of errors during each trial (over 25 trials)
Description
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
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Hertle, MD
Organizational Affiliation
Akron Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Akron Children's Hospital
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
10396626
Citation
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.
Results Reference
background
PubMed Identifier
15337140
Citation
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.
Results Reference
background
PubMed Identifier
16076336
Citation
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.
Results Reference
background
Citation
World Health Organization. Preventing blindness in children: report of WHO/IAPB scientific meeting. Geneva: WHO, 2000. (WHO/PBL/00.77.)
Results Reference
background
PubMed Identifier
15578200
Citation
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.
Results Reference
background
PubMed Identifier
16385646
Citation
Danilov Y, Tyler M. Brainport: an alternative input to the brain. J Integr Neurosci. 2005 Dec;4(4):537-50. doi: 10.1142/s0219635205000914.
Results Reference
background
PubMed Identifier
15634727
Citation
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.
Results Reference
background
Citation
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
Results Reference
background
Links:
URL
http://www.nei.nih.gov/eyedata/pbd_tables.asp
Description
Prevalence of blindness

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

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