NCT02393118

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2014

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 19, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

March 2, 2016

Status Verified

March 1, 2016

Enrollment Period

2 years

First QC Date

March 2, 2015

Last Update Submit

March 1, 2016

Conditions

Blindness

Keywords

Assistive technologyNon-surgical visual prostheticsensory substitutionBrainPortBlindnessAssistive device

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (7)

  • Text identification task

    12 months

  • Navigation task

    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.

  • +4 more other outcomes

Study Arms (1)

BrainPort V200 Device

EXPERIMENTAL

Single Arm

Device: BrainPort V200 Device

Interventions

BrainPort V200 DeviceDEVICE

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.

BrainPort V200 Device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A minimum age of 18 years at enrollment.
  • A documented vision diagnosis of light perception or worse bilaterally.
  • Blinded by traumatic injury (i.e., ocular or cortical trauma).
  • Minimum post 12 months diagnosis of blindness.
  • Previous completion of conventional rehabilitation such as orientation and mobility training with a cane or guide dog.
  • Ability to read (or have read to them) and understand study documents and procedures.
  • Ability to provide valid feedback regarding use of the BrainPort device.
  • Access to an accessible computer and internet connection.
  • 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.
  • Ability to operate a tablet computer.

You may not qualify if:

  • Current oral health problems determined by the participant's medical history and an examination of the oral cavity performed by study personnel.
  • History of injury to the tongue resulting in impaired sensation of use of the tongue.
  • Visible open lesions, cold sores, abrasions, blisters, or rash on the tongue, numbness or lack of feeling of the tongue.
  • Piercings on the tongue.
  • Recent or planned oral surgery and/or dental work in the past three months (does not include routine dental health exams/cleanings).
  • Known neuropathies of the tongue or tactile system.
  • History of seizures or epilepsy.
  • 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.
  • People with implanted medical devices (i.e., pacemaker, deep brain stimulator, cochlear implant).
  • Any hearing impairments which prevents hearing the device announcements.
  • Any cognitive disabilities (such as Alzheimer's disease), as determined by medical history and/or the Telephone Inventory Cognitive Screening (TICS).
  • Participation in any other clinical trial or research while my confound results in either study.
  • Known allergy to nickel, gold, or any component of stainless steel.
  • Any medical condition that would interfere with performance on the assessments.
  • The Site Principal Investigator does not deem the candidate to be suitable for the study for other reasons not listed above.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

The Chicago Lighthouse for People Who Are Blind or Visually Impaired

Chicago, Illinois, 60608, United States

Location

Lighthouse Guild

New York, New York, 10022, United States

Location

Wicab, Inc.

Middleton, Wisconsin, 53562, United States

Location

Related Publications (1)

  • 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.

    PMID: 30169354DERIVED

MeSH Terms

Conditions

Blindness

Condition Hierarchy (Ancestors)

Vision DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Patricia Grant, M.S.

    Wicab, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2015

First Posted

March 19, 2015

Study Start

September 1, 2014

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

March 2, 2016

Record last verified: 2016-03

Locations

US(3)