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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02393118
Recruitment Status : Unknown
Verified March 2016 by Wicab.
Recruitment status was:  Active, not recruiting
First Posted : March 19, 2015
Last Update Posted : March 2, 2016
Sponsor:
Collaborators:
The Chicago Lighthouse
Lighthouse Guild
Information provided by (Responsible Party):
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).

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

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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

Resource links provided by the National Library of Medicine


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.




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 ]


Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02393118


Locations
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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
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Principal Investigator: Patricia Grant, M.S. Wicab, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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    Key Record Dates
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:
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Blindness
Wounds and Injuries
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Eye Diseases