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

• ClinicalTrials.gov Identifier: NCT02393118
• Recruitment Status: Unknown
• First Posted: March 19, 2015
• Last Update Posted: March 2, 2016
• Sponsor: Wicab
• Collaborators: The Chicago Lighthouse; Lighthouse Guild
• Information provided by (Responsible Party): Wicab

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Blindness	Device: BrainPort V200 Device	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Safety and Efficacy of the BrainPort V200 Device in Individuals Blinded by Traumatic Injury
• Study Start Date: September 2014
• Estimated Primary Completion Date: September 2016
• Estimated Study Completion Date: September 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: BrainPort V200 Device; Single Arm	Device: BrainPort V200 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.

Outcome Measures

Primary Outcome Measures :

1. To assess the safety of electrical stimulation on the tongue (to demonstrate no occurrence of a clinically significant device-related adverse event) [ Time Frame: 12 months ]
   The primary safety objective is to demonstrate no occurrence of a clinically significant device-related adverse event.
2. 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) [ Time Frame: 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.

Other Outcome Measures:

1. Text identification task [ Time Frame: 12 months ]
   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.
2. Navigation task [ Time Frame: 12 months ]
   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.
3. 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). [ Time Frame: Baseline, 12 months after device training. ]
4. Change in self-efficacy after using the device for one year as measured by the General Self-Efficacy Scale (GSES) [ Time Frame: Basline, 12 months after device training. ]
5. Change in perceived general pain after using the device for one year as measured by the Universal Pain Assessment Tool [ Time Frame: Baseline,12 months after device training ]
6. Change in satisfaction of the device after using the device for one year, as measured by the Device Satisfaction Survey [ Time Frame: One month after start of home use, 12 months after device training ]
7. Optional focus group to assess year long experience with the device. [ Time Frame: 12 months after device training ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

United States, Illinois

The Chicago Lighthouse for People Who Are Blind or Visually Impaired

Chicago, Illinois, United States, 60608

United States, New York

Lighthouse Guild

New York, New York, United States, 10022

United States, Wisconsin

Wicab, Inc.

Middleton, Wisconsin, United States, 53562

Sponsors and Collaborators

Wicab

The Chicago Lighthouse

Lighthouse Guild

Investigators

• Principal Investigator: Patricia Grant, M.S.; Wicab, Inc.

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Wicab
• ClinicalTrials.gov Identifier: NCT02393118
• Other Study ID Numbers: WCB14-492; CDMRP-DM130076 ( Other Grant/Funding Number: U.S. Department of Defense )
• First Posted: March 19, 2015
• Last Update Posted: March 2, 2016
• Last Verified: March 2016

Keywords provided by Wicab:

Assistive technology; Non-surgical visual prosthetic; sensory substitution; BrainPort; Blindness; Assistive device

Additional relevant MeSH terms:

Blindness; Wounds and Injuries; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases