BlindnessNCT02393118
A Study to Evaluate the BrainPort Vision Device in Individuals Blinded by Traumatic Injury
A study testing BrainPort V200 Device in people with Blindness, run by Wicab at 3 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blindness
- What is being tested?
- BrainPort V200 Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2014to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
The Chicago Lighthouse for People Who Are Blind or Visually Impaired
Chicago, Illinois, 60608
Wicab, Inc.
Middleton, Wisconsin, 53562
Lighthouse Guild
New York, New York, 10022
About this study
Official title: 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).
- Conditions
- Blindness
- Being tested
- BrainPort V200 Device
- Keywords
- Assistive technology, Non-surgical visual prosthetic, sensory substitution, BrainPort, Blindness, Assistive device
- Medical subject headings
- Blindness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| BrainPort V200 Device | Experimental | Single Arm Receives: Device: BrainPort V200 Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study startSep 2014
- Primary completionSep 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BlindnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wicab
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Chicago Lighthouse, Lighthouse Guild
- Responsible party
- Sponsor
- Investigators
- Patricia Grant, M.S., Principal investigator, Wicab, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02393118
- Sponsor's protocol ID
- WCB14-492
- Other IDs
- CDMRP-DM130076
- Status last verified
- Mar 2016
- First submitted
- 2 Mar 2015
- Last updated
- 2 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of the BrainPort V200 Device in Individuals Blinded by Traumatic Injury
- ClinicalTrials.gov ID
- NCT02393118
- Acronym / sponsor ID
- WCB14-492
- Conditions
- Blindness
- Keywords
- Assistive technology, Non-surgical visual prosthetic, sensory substitution, BrainPort, Blindness, Assistive device
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- WicabIndustry (pharma, biotech, devices)
- Collaborators
- The Chicago Lighthouse, Lighthouse Guild
- Study start
- Sep 2014
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 19 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BrainPort V200 Device | Experimental | Device: BrainPort V200 DeviceSingle Arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (15 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrainPort V200 DeviceTraining 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. | Device | BrainPort V200 Device |
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2016.
- Derived from this study: PubMed 30169354Grant 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Grant, M.S. principal investigator
Wicab, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BrainPort V200 Device in people with Blindness, run by Wicab at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02393118, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2016; AzTrials last refreshed its copy on 2 Nov 2026.