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

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ClinicalTrials.gov Identifier: NCT02643238
Recruitment Status : Unknown
Verified December 2015 by Akron Children's Hospital.
Recruitment status was:  Recruiting
First Posted : December 31, 2015
Last Update Posted : December 31, 2015
Sponsor:
Information provided by (Responsible Party):
Akron Children's Hospital

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.

Condition or disease Intervention/treatment Phase
Blindness Device: BrainPort Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Continued Study of Artificial Vision: Evaluation of the BrainPort® System and Investigation of Visual Ambulation
Study Start Date : October 2011
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : September 2017

Arm Intervention/treatment
Experimental: 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.
Device: 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

Active Comparator: 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.
Device: 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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02643238


Contacts
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Contact: Maryan Mathis, MS, BSN 330-543-8272 MMathis@chmca.org
Contact: Aris Eliades, PhD, RN 330-543-3193 aeliades@chmca.org

Locations
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United States, Ohio
Akron Children's Hospital Recruiting
Akron, Ohio, United States, 44308
Contact: Richard M Hertle, M.D.    330-543-5290    RHertle@chmca.org   
Contact: Maryan Mathis, MS, BSN    330-543-8272    MMathis@chmca.org   
Principal Investigator: Richard M Hertle, M.D.         
Sponsors and Collaborators
Akron Children's Hospital
Investigators
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Principal Investigator: Richard Hertle, MD Akron Children's Hospital

Additional Information:
Publications:
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Responsible Party: Akron Children's Hospital
ClinicalTrials.gov Identifier: NCT02643238     History of Changes
Other Study ID Numbers: 111009
First Posted: December 31, 2015    Key Record Dates
Last Update Posted: December 31, 2015
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Blindness
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Eye Diseases
Signs and Symptoms