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

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).

Study Overview

• Status: Unknown
• Conditions: Blindness
• Intervention / Treatment: Device: BrainPort V200 Device

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60608
      • The Chicago Lighthouse for People Who Are Blind or Visually Impaired
  • New York
    • New York, New York, United States, 10022
      • Lighthouse Guild
  • Wisconsin
    • Middleton, Wisconsin, United States, 53562
      • Wicab, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Wicab
• Collaborators: The Chicago Lighthouse; Lighthouse Guild
• Investigators: Principal Investigator: Patricia Grant, M.S., Wicab, Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (ANTICIPATED): September 1, 2016
• Study Completion (ANTICIPATED): September 1, 2016

Study Registration Dates

• First Submitted: March 2, 2015
• First Submitted That Met QC Criteria: March 13, 2015
• First Posted (ESTIMATE): March 19, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): March 2, 2016
• Last Update Submitted That Met QC Criteria: March 1, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Assistive technology; Blindness; sensory substitution; Assistive device; BrainPort; Non-surgical visual prosthetic
• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Sensation Disorders; Vision Disorders; Wounds and Injuries; Blindness
• Other Study ID Numbers: WCB14-492; CDMRP-DM130076 (OTHER_GRANT: U.S. Department of Defense)