A Study to Evaluate the BrainPort Vision Device in Individuals Blinded by Traumatic Injury

Not Applicable

• Conditions: Blindness
• Interventions: Device: BrainPort V200 Device

• Registration Number: NCT02393118
• Lead Sponsor: Wicab

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2015-03-02
• Study First Submitted QC: 2015-03-13
• Study First Posted: 2015-03-19
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-01
• Last Update Posted: 2016-03-02
• Primary Completion: 2016-09
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BrainPort V200 Device	BrainPort V200 Device	Single Arm

Primary Outcome Measures

Name	Time	Method
To assess the safety of electrical stimulation on the tongue (to demonstrate no occurrence of a clinically significant device-related adverse event)	12 months	The primary safety objective is to demonstrate no occurrence of a clinically significant device-related adverse event.
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)	12 months	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.

Trial Locations

Locations (3)

Lighthouse Guild; 🇺🇸 New York, New York, United States

The Chicago Lighthouse for People Who Are Blind or Visually Impaired; 🇺🇸 Chicago, Illinois, United States

Wicab, Inc.; 🇺🇸 Middleton, Wisconsin, United States