Continued Study of Artificial Vision: Evaluation of the BrainPort® System and Investigation of Visual Ambulation
BrainPort
1 other identifier
interventional
7
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 23, 2015
CompletedFirst Posted
Study publicly available on registry
December 31, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2022
CompletedNovember 16, 2022
November 1, 2022
5.2 years
December 23, 2015
November 14, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Average Number of errors during each trial (over 25 trials)
1 month
Study Arms (2)
Group A - Blind
EXPERIMENTALSubjects 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 C - Control
ACTIVE COMPARATORSubjects 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.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Akron Children's Hospital
Akron, Ohio, 44308, United States
Related Publications (8)
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.
PMID: 10396626BACKGROUNDChowdhury 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.
PMID: 15337140BACKGROUNDChowdhury 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.
PMID: 16076336BACKGROUNDWorld Health Organization. Preventing blindness in children: report of WHO/IAPB scientific meeting. Geneva: WHO, 2000. (WHO/PBL/00.77.)
BACKGROUNDSachs 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.
PMID: 15578200BACKGROUNDDanilov Y, Tyler M. Brainport: an alternative input to the brain. J Integr Neurosci. 2005 Dec;4(4):537-50. doi: 10.1142/s0219635205000914.
PMID: 16385646BACKGROUNDPtito 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.
PMID: 15634727BACKGROUNDO'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
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Hertle, MD
Akron Children's Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 23, 2015
First Posted
December 31, 2015
Study Start
October 1, 2011
Primary Completion
December 1, 2016
Study Completion
May 1, 2022
Last Updated
November 16, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share