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Status unknownNCT02393118Updated Mar 2, 2016

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

An interventional study of BrainPort V200 Device in Blindness, sponsored by Wicab. Status unknown at 3 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-03-02.

Sponsored by Wicab · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Mar 2016), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Blindness

Keywords

  • Assistive technology
  • Non-surgical visual prosthetic
  • sensory substitution
  • BrainPort
  • Blindness
  • Assistive device
03

In context

Blindness

161 studies on the registry are indexed under Blindness; 33 are open to participants now.

This study's enrollment of 20 is below the median of 30 across 105 interventional studies indexed under Blindness.

Browse Blindness studies →

Lead sponsor

Wicab is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    BrainPort V200 Device

    Single Arm

    Device: BrainPort V200 Device

Interventions

  • DeviceBrainPort 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 months

  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)

    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.

    Time frame: 12 months

Other outcomes

  1. 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.

    Time frame: 12 months

  2. 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.

    Time frame: 12 months

  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

07

Study locations

3 sites
  • The Chicago Lighthouse for People Who Are Blind or Visually Impaired
    Chicago, Illinois 60608, United States
  • Lighthouse Guild
    New York, New York 10022, United States
  • Wicab, Inc.
    Middleton, Wisconsin 53562, United States
08

References and documents

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. PubMed 30169354 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02393118
Lead sponsor
Wicab
Collaborators
The Chicago Lighthouse, Lighthouse Guild
Responsible party
Sponsor
First posted
Mar 19, 2015
Start date
Sep 2014
Primary completion
Sep 2016 (estimated)
Completion
Sep 2016 (estimated)
Last update
Mar 2, 2016

Study contacts

Patricia Grant, M.S.
principal investigator · Wicab, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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