A Study to Evaluate the BrainPort® Vision Device in Subjects Who Are Blind

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety of the BrainPort vision device and to demonstrate improved object recognition and word identification and ambulation with use of the BrainPort vision device in subjects who are medically documented as blind, with acuity of 20/ 5000 or worse.

Official Title
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A Study to Evaluate the Safety and Efficacy of the BrainPort® Vision Device in Subjects Who Are Blind

Conditions
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Blindness

Intervention / Treatment
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* Device: BrainPort Vision Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed written medical or low vision diagnosis of No Light Perception or Light Perception Performance on the FrACT acuity test of worse than 20/5000 or impossible to measure. Minimum post 6 months diagnosis blindness. Previously completed conventional rehabilitation such as orientation and mobility training with a cane or guide dog. Able to have read to him or her, understand, and sign the informed consent form. Daily access to an accessible computer with email for study communication, device- use logging and access to device user manual preferred. Willing and able to complete all testing, training, and follow- up evaluations required by the study protocol, after receiving a short orientation on the use of the device. Exclusion Criteria: Current oral health problems as determined from the oral health exam which preclude enrollment in the study in the judgment of the Principal Investigator. Any medical condition that would interfere with performance on the assessments. Prior use of the BrainPort vision device. Known neuropathies of tongue or skin tactile system. Smoke or chew tobacco products less than 12 months prior to study enrollment Any allergies to nickel or stainless steel History of seizures or epilepsy. If female, pregnant. Women of child bearing potential must agree to use appropriate birth control to prevent pregnancy for the duration of the study. People with implanted electrical medical devices (i.e. pacemaker, deep brain stimulator, cochlear implant). Psychiatric disease including anxiety disorders and forms of depression (using provided Beck Anxiety Inventory (BAI) and Beck Depression Inventory (BDI- II) as screening tools). Any disease or condition that prevents understanding or communication of informed consent, study demands and testing protocols including the following: Cognitive decline including forms of dementia and/or progressive neurological disease Deafness or selective frequency hearing loss that prevents hearing device alarms and alerts. Does not speak English Blindness occurring due to cortical injury (i.e. stroke, traumatic brain injury, etc) Principal Investigator, in his or her judgment, does not believe the subject is a good candidate for the trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BrainPort Vision Device<br>Single Arm | Device: BrainPort Vision Device<br>* 2-3 days of training (10 hours) followed by minimum in-home use 300 minutes per month for 12 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | The primary safety objective is to demonstrate that the rate of clinically significant device-related adverse events is less than 10%. This will require an observed event-free rate of approximately 97%. | 1 year | 
| Object Recognition | The primary efficacy objective is to demonstrate that at least 50% of subjects achieve a success rate in object recognition exceeding that expected by chance alone. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Word Identification | A secondary efficacy objective is to demonstrate that at least 50% of subjects correctly identify at least 50% of a series of three- to five-letter words. | 1 year | 
| Ambulation/Mobility | Another secondary efficacy objective is to demonstrate at least 35% of subjects demonstrate sign recognition in a mobility task. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Assistive Technology, Non-Surgical Visual Prosthetic, Sensory Substitution