A Study to Evaluate the BrainPort Vision Device in Individuals Blinded by Traumatic Injury
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Hospital, Ocular |
| Therapuetic Areas: | Ophthalmology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | September 2014 |
| End Date: | September 2016 |
Safety and Efficacy of the BrainPort V200 Device in Individuals Blinded by Traumatic Injury
The BrainPort V200 Device is a wearable, non-surgical, prosthetic device intended for people
who are profoundly blind. The BrainPort V200 translates images captured by a digital camera
into electro-tactile stimulation presented on the user's tongue to perceive shape, size,
location, and motion of objects within the environment. The purpose of this study is to
evaluate the safety and functional performance of the BrainPort V200 device in individuals
who have been medically documented as blind, light perception or worse, due to a traumatic
injury (cortical or ocular).
who are profoundly blind. The BrainPort V200 translates images captured by a digital camera
into electro-tactile stimulation presented on the user's tongue to perceive shape, size,
location, and motion of objects within the environment. The purpose of this study is to
evaluate the safety and functional performance of the BrainPort V200 device in individuals
who have been medically documented as blind, light perception or worse, due to a traumatic
injury (cortical or ocular).
Inclusion Criteria:
1. A minimum age of 18 years at enrollment.
2. A documented vision diagnosis of light perception or worse bilaterally.
3. Blinded by traumatic injury (i.e., ocular or cortical trauma).
4. Minimum post 12 months diagnosis of blindness.
5. Previous completion of conventional rehabilitation such as orientation and mobility
training with a cane or guide dog.
6. Ability to read (or have read to them) and understand study documents and procedures.
7. Ability to provide valid feedback regarding use of the BrainPort device.
8. Access to an accessible computer and internet connection.
9. Willing and able to complete all questionnaires, telephone conferences, device
training, and study procedures required by the protocol, after completing an
orientation period with the device.
10. Ability to operate a tablet computer.
Exclusion Criteria:
1. Current oral health problems determined by the participant's medical history and an
examination of the oral cavity performed by study personnel.
2. History of injury to the tongue resulting in impaired sensation of use of the tongue.
3. Visible open lesions, cold sores, abrasions, blisters, or rash on the tongue,
numbness or lack of feeling of the tongue.
4. Piercings on the tongue.
5. Recent or planned oral surgery and/or dental work in the past three months (does not
include routine dental health exams/cleanings).
6. Known neuropathies of the tongue or tactile system.
7. History of seizures or epilepsy.
8. If female, pregnant or breast feeding by self-report. Women of child bearing
potential must agree to use appropriate birth control to prevent pregnancy for the
duration of the study.
9. People with implanted medical devices (i.e., pacemaker, deep brain stimulator,
cochlear implant).
10. Any hearing impairments which prevents hearing the device announcements.
11. Any cognitive disabilities (such as Alzheimer's disease), as determined by medical
history and/or the Telephone Inventory Cognitive Screening (TICS).
12. Participation in any other clinical trial or research while my confound results in
either study.
13. Known allergy to nickel, gold, or any component of stainless steel.
14. Any medical condition that would interfere with performance on the assessments.
15. The Site Principal Investigator does not deem the candidate to be suitable for the
study for other reasons not listed above.
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3
sites
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