BlindnessNCT04725760
Evaluation of the Efficacy of the BrainPort Vision Pro on the Performance of Daily Activities in the Profoundly Blind French Population
A study testing BrainPort Vision Pro in people with Blindness, run by Wicab at 7 sites in France.
Trial summary
The purpose of the study is to evaluate the effectiveness and safety of the BrainPort® Vision Pro, an electronic oral assistive device, in the performance of daily tasks by French persons who have residual vision limited to light perception or less in both eyes. Read more about this study
- Who is it for?
- Ages 8 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blindness
- What is being tested?
- BrainPort Vision Pro
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 7 sitesFrance
- Study dates
- 1 Oct 2020to 30 Sep 2022
- 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 8 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 8 years of age or older
- Diagnosis of profound blindness with residual vision limited to a perception of light or lower in both eyes.
- Minimum post 12 months diagnosis of blindness
- Previously completed conventional rehabilitation such as orientation and mobility training with a cane or guide dog.
- Ability to be read and to understand the documentation and procedures of the study.
- Ability to provide feedback on the use of the BrainPort Vision Pro device.
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- Ability to use basic computer and/or other technologies.
- Willing and able to answer all questionnaires, carry out telephone follow-ups, undergo device training and carry out all study procedures, after having passed the orientation phase with the device.
- Participant or his legal representative willing and able to sign informed consent.
Who cannot join
- Ongoing oral disorders determined on the basis of the participant's medical history and/or by an examination of the oral cavity by a dental specialist.
- History of tongue damage resulting in sensitivity problems or impaired language.
- Visible open sores, herpes, abrasions, blisters or rashes on the tongue or numbness of the tongue.
- Piercings on the tongue.
- Planned or recent oral surgery (in the last 3 months) and/or dental care (excluding oral check-ups or routine scaling).
- Known neuropathy of the language or sensory system.
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- History of seizures or epilepsy.
- Pregnant woman, willing to be pregnant or lactating. Women of childbearing age should consent to the use of appropriate contraception to avoid pregnancy during the study period.
- Implanted medical devices (e.g., pacemaker, deep brain stimulation device, cochlear implant).
- Any hearing impairment that prevents you from hearing the device's announcements.
- Cognitive impairment detected on the basis of medical history and/or during a cognitive impairment telephone interview.
- Expected or ongoing participation in another clinical trial or any research that may interfere with this study.
- Known allergy to nickel, gold or a stainless-steel component.
- Any health condition that may interfere with the study's evaluations.
- A person unable to assemble the device and/or interpret the device's signals or who refuses to continue to participate in the study after passing the initial training phase with the device.
- Person deemed unfit to participate in the study by the lead investigator for any other previously cited reason.
- Adults who do not have the ability to provide valid informed consent (under legal protection)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites, 7 recruiting
- Not yet recruiting
University Hospital La Timone
Marseille
Danièle Denis, M.D., 04 91 38 54 68, daniele.denis@ap-hm.fr
Danièle Denis, M.D.
- Not yet recruiting
CHU de Montpellier
Montpellier
Isabelle Meunier, M.D., 04 67 33 02 78, msg@chu-montpellier.fr
Isabelle Meunier, M.D.
- Not yet recruiting
University Hospital of Nantes
Nantes
Michel Weber, M.D., 02 40 08 36 56, miweber@chu-nantes.fr
Michel Weber, M.D.
- Recruiting
Institut Aramav
Nîmes
Luc Jeanjean, M.D., 04 66 23 48 55, Luc.Jeanjean@chu-nimes.fr
Luc Jeanjean, M.D.
- Recruiting
Fondation hospitalière Sainte-Marie
Paris
Pierre, M.D., 06 83 85 57 63
M.D.
- Recruiting
Necker-Enfants Malades Hospital
Paris
Dominique Bremond-Gignac, M.D., 01 44 49 54 43, dominique.bremond@aphp.fr
Dominique Bremond-Gignac, M.D.
- Recruiting
Hôpitaux Universitaires de Strasbourg, Reference Center for Rare Disorders in Ophthalmic Genetics
Strasbourg
Hélène Dollfus, M.D., Ph.D., 03 88 12 81 20, helene.dollfus@chru-strasbourg.fr
Hélène Dollfus, M.D., Ph.D.
About this study
The purpose of the study is to evaluate the effectiveness and safety of the BrainPort® Vision Pro, an electronic oral assistive device, in the performance of daily tasks by French persons who have residual vision limited to light perception or less in both eyes.
- Conditions
- Blindness
- Being tested
- BrainPort Vision Pro
- Keywords
- blindness, brainport, brainport vision pro, assistive device, assistive technology, visual impairment
- Medical subject headings
- Blindness, Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrainPort Vision ProDevice
Ten hours of training over 3 to 5 days, followed by autonomous use of the device.
It will be recommended that the subject use the BrainPort® Vision Pro device for at least 5 hours per month for a period of 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Single Group Assisgnment | Experimental | Not described Receives: Device: BrainPort Vision Pro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Function
Ultra Low Vision - Visual Function Questionnaire - 50 (ULV-VFQ-50), Aa validated self-assessment scale to measure functional vision in people with ultra low vision. 50 items on a Likert scale, ranging from 1-4, higher scores indicated more difficult (lower visual ability)
Measured: Baseline
Visual Function
Ultra Low Vision - Visual Function Questionnaire - 50 (ULV-VFQ-50), Aa validated self-assessment scale to measure functional vision in people with ultra low vision 50 items on a Likert scale, ranging from 1-4, higher scores indicated more difficult (lower visual ability)
Measured: 3 months
Visual Function
Ultra Low Vision - Visual Function Questionnaire - 50 (ULV-VFQ-50), Aa validated self-assessment scale to measure functional vision in people with ultra low vision 50 items on a Likert scale, ranging from 1-4, higher scores indicated more difficult (lower visual ability)
Measured: 6 months
Visual Function
Ultra Low Vision - Visual Function Questionnaire - 50 (ULV-VFQ-50), Aa validated self-assessment scale to measure functional vision in people with ultra low vision 50 items on a Likert scale, ranging from 1-4, higher scores indicated more difficult (lower visual ability)
Measured: 12 months
Secondary outcomes (17)
Object recognition
Subjects will be asked to reach and grasp one of four objects requested by the examiner, without touching any other object. A total of 10 tests will be conducted. If the test is not answered after two minutes, the test will be considered incorrect. The number of correctly identified objects will be recorded.
Measured: Baseline
Character identification
High contrast letters and numbers will be presented. Subjects will be required to orally identify each letter or number presented. The total number of correct answers will be recorded. Ten individual letters/numbers will be presented.
Measured: Baseline
Orientation and mobility tasks
This task will measure participants' ability to navigate a room and identify distinct objects and features in their environment, such as windows and doorways.
Measured: Baseline
Object recognition
Subjects will be asked to reach and grasp one of four objects requested by the examiner, without touching any other object. A total of 10 tests will be conducted. If the test is not answered after two minutes, the test will be considered incorrect. The number of correctly identified objects will be recorded.
Measured: 3 months
Character identification
High contrast letters and numbers will be presented. Subjects will be required to orally identify each letter or number presented. The total number of correct answers will be recorded. Ten individual letters/numbers will be presented.
Measured: 3 months
Orientation and mobility tasks
This task will measure participants' ability to navigate a room and identify distinct objects and features in their environment, such as windows and doorways.
Measured: 3 months
Object recognition
Subjects will be asked to reach and grasp one of four objects requested by the examiner, without touching any other object. A total of 10 tests will be conducted. If the test is not answered after two minutes, the test will be considered incorrect. The number of correctly identified objects will be recorded.
Measured: 6 months
Character identification
High contrast letters and numbers will be presented. Subjects will be required to orally identify each letter or number presented. The total number of correct answers will be recorded. Ten individual letters/numbers will be presented.
Measured: 6 months
Orientation and mobility tasks
This task will measure participants' ability to navigate a room and identify distinct objects and features in their environment, such as windows and doorways.
Measured: 6 months
Object recognition
Subjects will be asked to reach and grasp one of four objects requested by the examiner, without touching any other object. A total of 10 tests will be conducted. If the test is not answered after two minutes, the test will be considered incorrect. The number of correctly identified objects will be recorded.
Measured: 12 months
Character identification
High contrast letters and numbers will be presented. Subjects will be required to orally identify each letter or number presented. The total number of correct answers will be recorded. Ten individual letters/numbers will be presented.
Measured: 12 months
Orientation and mobility tasks
This task will measure participants' ability to navigate a room and identify distinct objects and features in their environment, such as windows and doorways.
Measured: 12 months
Impact of Vision Impairment-Very Low Vision Quality of Life Scale
A vision-related quality of life scale for participants with very low vision 28 items on a Likert scale, ranging from 1-3 with higher scores indicating better vision-related quality of life.
Measured: Baseline
Impact of Vision Impairment-Very Low Vision Quality of Life Scale,
A vision-related quality of life scale for participants with very low vision 28 items on a Likert scale, ranging from 1-3 with higher scores indicating better vision-related quality of life.
Measured: 3 months
Impact of Vision Impairment-Very Low Vision Quality of Life Scale,
A vision-related quality of life scale for participants with very low vision 28 items on a Likert scale, ranging from 1-3 with higher scores indicating better vision-related quality of life.
Measured: 6 months
Impact of Vision Impairment-Very Low Vision Quality of Life Scale,
A vision-related quality of life scale for participants with very low vision 28 items on a Likert scale, ranging from 1-3 with higher scores indicating better vision-related quality of life.
Measured: 12 months
Adverse events related to device or study procedures
Safety
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 posted27 Jan 2021
- Study start1 Oct 2020
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
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
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wicab
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patricia Grant, Ph.D., Study director, Wicab, Inc.Isabelle Audo, Ph.D., Principal investigator, National Hospital for Ophthalmology of the Fifteen-Vingts
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04725760
- Sponsor's protocol ID
- 2020-WIFR-8313
- Status last verified
- Jan 2021
- First submitted
- 15 Jan 2021
- Last updated
- 10 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of the BrainPort Vision Pro on the Performance of Daily Activities in the Profoundly Blind French Population
- ClinicalTrials.gov ID
- NCT04725760
- Acronym / sponsor ID
- 2020-WIFR-8313
- Conditions
- Blindness
- Keywords
- blindness, brainport, brainport vision pro, assistive device, assistive technology, visual impairment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- WicabIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 27 Jan 2021 (actual)
- 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 the study is to evaluate the effectiveness and safety of the BrainPort® Vision Pro, an electronic oral assistive device, in the performance of daily tasks by French persons who have residual vision limited to light perception or less in both eyes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group Assisgnment | Experimental | Device: BrainPort Vision Pro |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 8 years of age or older
- Diagnosis of profound blindness with residual vision limited to a perception of light or lower in both eyes.
- Minimum post 12 months diagnosis of blindness
- Previously completed conventional rehabilitation such as orientation and mobility training with a cane or guide dog.
- Ability to be read and to understand the documentation and procedures of the study.
Key exclusion criteria (17 listed)
- Ongoing oral disorders determined on the basis of the participant's medical history and/or by an examination of the oral cavity by a dental specialist.
- History of tongue damage resulting in sensitivity problems or impaired language.
- Visible open sores, herpes, abrasions, blisters or rashes on the tongue or numbness of the tongue.
- Piercings on the tongue.
- Planned or recent oral surgery (in the last 3 months) and/or dental care (excluding oral check-ups or routine scaling).
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 ProTen hours of training over 3 to 5 days, followed by autonomous use of the device. It will be recommended that the subject use the BrainPort® Vision Pro device for at least 5 hours per month for a period of 12 months. | Device | Single Group Assisgnment |
Primary outcome
Visual Function
Time frame: Baseline
Ultra Low Vision - Visual Function Questionnaire - 50 (ULV-VFQ-50), Aa validated self-assessment scale to measure functional vision in people with ultra low vision. 50 items on a Likert scale, ranging from 1-4, higher scores indicated more difficult (lower visual ability)
Visual Function
Time frame: 3 months
Ultra Low Vision - Visual Function Questionnaire - 50 (ULV-VFQ-50), Aa validated self-assessment scale to measure functional vision in people with ultra low vision 50 items on a Likert scale, ranging from 1-4, higher scores indicated more difficult (lower visual ability)
Visual Function
Time frame: 6 months
Ultra Low Vision - Visual Function Questionnaire - 50 (ULV-VFQ-50), Aa validated self-assessment scale to measure functional vision in people with ultra low vision 50 items on a Likert scale, ranging from 1-4, higher scores indicated more difficult (lower visual ability)
Visual Function
Time frame: 12 months
Ultra Low Vision - Visual Function Questionnaire - 50 (ULV-VFQ-50), Aa validated self-assessment scale to measure functional vision in people with ultra low vision 50 items on a Likert scale, ranging from 1-4, higher scores indicated more difficult (lower visual ability)
17 secondary outcomes
Object recognition
Time frame: Baseline
Character identification
Time frame: Baseline
Orientation and mobility tasks
Time frame: Baseline
Object recognition
Time frame: 3 months
Character identification
Time frame: 3 months
Orientation and mobility tasks
Time frame: 3 months
Object recognition
Time frame: 6 months
Character identification
Time frame: 6 months
Orientation and mobility tasks
Time frame: 6 months
Object recognition
Time frame: 12 months
Character identification
Time frame: 12 months
Orientation and mobility tasks
Time frame: 12 months
Impact of Vision Impairment-Very Low Vision Quality of Life Scale
Time frame: Baseline
Impact of Vision Impairment-Very Low Vision Quality of Life Scale,
Time frame: 3 months
Impact of Vision Impairment-Very Low Vision Quality of Life Scale,
Time frame: 6 months
Impact of Vision Impairment-Very Low Vision Quality of Life Scale,
Time frame: 12 months
Adverse events related to device or study procedures
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2021.
- Sponsor website, description of BrainPort Vision ProLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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, Ph.D. study director
Wicab, Inc.
Isabelle Audo, Ph.D. principal investigator
National Hospital for Ophthalmology of the Fifteen-Vingts
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BrainPort Vision Pro in people with Blindness, run by Wicab at 7 sites in France.
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 9 inclusion and 17 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 10 Nov 2021. 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 France. 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?
Contact Patricia Grant, Ph.D. (312-447-3234, pgrant@wicab.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Function (time frame: Baseline). The study lists 4 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 10 Nov 2021.