BlindnessNCT01488786
A Study to Evaluate the BrainPort® Vision Device in Subjects Who Are Blind
A study testing BrainPort Vision Device in people with Blindness, run by Wicab at 7 sites in 2 countries.
Trial summary
The purpose of this study is to assess the safety of the BrainPort vision device and to demonstrate improved object recognition and word identification and ambulation with use of the BrainPort vision device in subjects who are medically documented as blind, with acuity of 20/ 5000 or worse. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Blindness
- What is being tested?
- BrainPort Vision Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Oct 2011to Apr 2013
- 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 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Confirmed written medical or low vision diagnosis of No Light Perception or Light Perception
- Performance on the FrACT acuity test of worse than 20/5000 or impossible to measure.
- Minimum post 6 months diagnosis blindness.
- Previously completed conventional rehabilitation such as orientation and mobility training with a cane or guide dog.
- Able to have read to him or her, understand, and sign the informed consent form.
- Daily access to an accessible computer with email for study communication, device- use logging and access to device user manual preferred.
- Willing and able to complete all testing, training, and follow- up evaluations required by the study protocol, after receiving a short orientation on the use of the device.
Who cannot join
- Current oral health problems as determined from the oral health exam which preclude enrollment in the study in the judgment of the Principal Investigator.
- Any medical condition that would interfere with performance on the assessments.
- Prior use of the BrainPort vision device.
- Known neuropathies of tongue or skin tactile system.
- Smoke or chew tobacco products less than 12 months prior to study enrollment
- Any allergies to nickel or stainless steel
Show all 16Show fewer
- History of seizures or epilepsy.
- If female, pregnant. Women of child bearing potential must agree to use appropriate birth control to prevent pregnancy for the duration of the study.
- People with implanted electrical medical devices (i.e. pacemaker, deep brain stimulator, cochlear implant).
- Psychiatric disease including anxiety disorders and forms of depression (using provided Beck Anxiety Inventory (BAI) and Beck Depression Inventory (BDI- II) as screening tools).
- Any disease or condition that prevents understanding or communication of informed consent, study demands and testing protocols including the following:
- Cognitive decline including forms of dementia and/or progressive neurological disease
- Deafness or selective frequency hearing loss that prevents hearing device alarms and alerts.
- Does not speak English
- Blindness occurring due to cortical injury (i.e. stroke, traumatic brain injury, etc)
- Principal Investigator, in his or her judgment, does not believe the subject is a good candidate for the trial.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States6 sites
The Chicago Lighthouse for People Who Are Blind and Visually Impaired
Chicago, Illinois, 60608
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Lighthouse International
New York, New York, 10022
Independence for the Blind of West Florida Inc.
Pensacola, Florida, 32503
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Envision
Wichita, Kansas, 67203
About this study
Official title: A Study to Evaluate the Safety and Efficacy of the BrainPort® Vision Device in Subjects Who Are Blind
The purpose of this study is to assess the safety of the BrainPort vision device and to demonstrate improved object recognition and word identification and ambulation with use of the BrainPort vision device in subjects who are medically documented as blind, with acuity of 20/ 5000 or worse.
- Conditions
- Blindness
- Being tested
- BrainPort Vision Device
- Keywords
- Assistive Technology, Non-Surgical Visual Prosthetic, Sensory Substitution
- Medical subject headings
- Blindness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrainPort Vision DeviceDevice
2-3 days of training (10 hours) followed by minimum in-home use 300 minutes per month for 12 months.
| Study group | Role | What they receive |
|---|---|---|
| BrainPort Vision Device | Experimental | Single Arm Receives: Device: BrainPort Vision Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
The primary safety objective is to demonstrate that the rate of clinically significant device-related adverse events is less than 10%. This will require an observed event-free rate of approximately 97%.
Measured: 1 year
Object Recognition
The primary efficacy objective is to demonstrate that at least 50% of subjects achieve a success rate in object recognition exceeding that expected by chance alone.
Measured: 1 year
Secondary outcomes (2)
Word Identification
A secondary efficacy objective is to demonstrate that at least 50% of subjects correctly identify at least 50% of a series of three- to five-letter words.
Measured: 1 year
Ambulation/Mobility
Another secondary efficacy objective is to demonstrate at least 35% of subjects demonstrate sign recognition in a mobility task.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2011 (estimated)
- Study startOct 2011
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wicab
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aimee Arnoldussen, Study director, Wicab, Inc.William Seiple, Principal investigator, Lighthouse International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01488786
- Sponsor's protocol ID
- WCB1-010
- Status last verified
- Aug 2013
- First submitted
- 6 Dec 2011
- Last updated
- 9 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Safety and Efficacy of the BrainPort® Vision Device in Subjects Who Are Blind
- ClinicalTrials.gov ID
- NCT01488786
- Acronym / sponsor ID
- WCB1-010
- Conditions
- Blindness
- Keywords
- Assistive Technology, Non-Surgical Visual Prosthetic, Sensory Substitution
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- WicabIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 8 Dec 2011 (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 purpose of this study is to assess the safety of the BrainPort vision device and to demonstrate improved object recognition and word identification and ambulation with use of the BrainPort vision device in subjects who are medically documented as blind, with acuity of 20/ 5000 or worse.
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 Vision Device | Experimental | Device: BrainPort Vision DeviceSingle Arm |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Confirmed written medical or low vision diagnosis of No Light Perception or Light Perception
- Performance on the FrACT acuity test of worse than 20/5000 or impossible to measure.
- Minimum post 6 months diagnosis blindness.
- Previously completed conventional rehabilitation such as orientation and mobility training with a cane or guide dog.
- Able to have read to him or her, understand, and sign the informed consent form.
Key exclusion criteria (16 listed)
- Current oral health problems as determined from the oral health exam which preclude enrollment in the study in the judgment of the Principal Investigator.
- Any medical condition that would interfere with performance on the assessments.
- Prior use of the BrainPort vision device.
- Known neuropathies of tongue or skin tactile system.
- Smoke or chew tobacco products less than 12 months prior to study enrollment
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 Vision Device2-3 days of training (10 hours) followed by minimum in-home use 300 minutes per month for 12 months. | Device | BrainPort Vision Device |
Primary outcome
Safety
Time frame: 1 year
The primary safety objective is to demonstrate that the rate of clinically significant device-related adverse events is less than 10%. This will require an observed event-free rate of approximately 97%.
Object Recognition
Time frame: 1 year
The primary efficacy objective is to demonstrate that at least 50% of subjects achieve a success rate in object recognition exceeding that expected by chance alone.
2 secondary outcomes
Word Identification
Time frame: 1 year
Ambulation/Mobility
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2013.
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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.
Aimee Arnoldussen study director
Wicab, Inc.
William Seiple principal investigator
Lighthouse International
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BrainPort Vision Device in people with Blindness, run by Wicab at 7 sites in 2 countries.
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 7 inclusion and 16 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: finished, as of the sponsor's last update on 9 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety (time frame: 1 year). 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?
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 9 Aug 2013.