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| ID | Type | Description | Link |
|---|---|---|---|
| CDMRP-DM130076 | Other Grant/Funding Number | U.S. Department of Defense |
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| Name | Class |
|---|---|
| The Chicago Lighthouse | OTHER |
| Lighthouse Guild | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BrainPort V200 Device | Experimental | Single Arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BrainPort V200 Device | Device | Training in clinic on use of the device for 2-3 days (10 hours) followed by in-home use for a minimum of 300 minutes per month over 12 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety of electrical stimulation on the tongue (to demonstrate no occurrence of a clinically significant device-related adverse event) | The primary safety objective is to demonstrate no occurrence of a clinically significant device-related adverse event. | 12 months |
| To assess the efficacy of the BrainPort device as measured by an object recognition task (to demonstrate at least 35% of subjects achieve a success rate in object recognition exceeding that expected by chance alone) | The primary efficacy objective is to demonstrate that at least 35% of subjects achieve a success rate in object recognition exceeding that expected by chance alone. | 12 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Text identification task | Words or sequence of numbers will be presented on flashcards and a mobile tablet, subjects will be asked to verbally identify which word or number is presented. | 12 months |
| Navigation task |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patricia Grant, M.S. | Wicab, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Chicago Lighthouse for People Who Are Blind or Visually Impaired | Chicago | Illinois | 60608 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30169354 | Derived | Grant P, Maeng M, Arango T, Hogle R, Szlyk J, Seiple W. Performance of Real-world Functional Tasks Using an Updated Oral Electronic Vision Device in Persons Blinded by Trauma. Optom Vis Sci. 2018 Sep;95(9):766-773. doi: 10.1097/OPX.0000000000001273. |
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| ID | Term |
|---|---|
| D001766 | Blindness |
| ID | Term |
|---|---|
| D014786 | Vision Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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Subjects will be required to identify key characteristics of a room, such as the number of windows and doorways and complete navigation tasks such as following a line, avoiding obstacles, and walking through a doorway without touching any walls.
| 12 months |
| Change in the effect of assistive technology on perceived quality of life after using the device for one year as measured by the Psychosocial Impact of Assistive Devices Scale (PIADS). | Baseline, 12 months after device training. |
| Change in self-efficacy after using the device for one year as measured by the General Self-Efficacy Scale (GSES) | Basline, 12 months after device training. |
| Change in perceived general pain after using the device for one year as measured by the Universal Pain Assessment Tool | Baseline,12 months after device training |
| Change in satisfaction of the device after using the device for one year, as measured by the Device Satisfaction Survey | One month after start of home use, 12 months after device training |
| Optional focus group to assess year long experience with the device. | 12 months after device training |
| Lighthouse Guild |
| New York |
| New York |
| 10022 |
| United States |
| Wicab, Inc. | Middleton | Wisconsin | 53562 | United States |
| D005128 |
| Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |