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

Blindness Clinical Trial

Official title:

Safety and Efficacy of the BrainPort V200 Device in Individuals Blinded by Traumatic Injury

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02393118
• Other study ID #: WCB14-492
• Secondary ID: CDMRP-DM130076
• Status: Active, not recruiting
• Phase: N/A
• First received: March 2, 2015
• Last updated: March 1, 2016
• Start date: September 2014
• Est. completion date: September 2016

Study information

• Verified date: March 2016
• Source: Wicab
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Blindness
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	The Chicago Lighthouse for People Who Are Blind or Visually Impaired	Chicago	Illinois
United States	Wicab, Inc.	Middleton	Wisconsin
United States	Lighthouse Guild	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Wicab	Lighthouse Guild, The Chicago Lighthouse for People Who Are Blind or Visually Impaired

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	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	No
Other	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.	No
Other	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.	No
Other	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	No
Other	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	No
Other	Optional focus group to assess year long experience with the device.		12 months after device training	No
Primary	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	Yes
Primary	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	No