Evaluation of the Efficacy of the BrainPort Vision Pro on the Performance of Daily Activities in the Profoundly Blind French Population
NCT ID: NCT04725760
Last Updated: 2021-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
125 participants
INTERVENTIONAL
2020-10-01
2022-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Single Group Assisgnment
BrainPort Vision Pro
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.
Interventions
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BrainPort Vision Pro
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.
Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of profound blindness with residual vision limited to a perception of light or lower in both eyes.
3. Minimum post 12 months diagnosis of blindness
4. Previously completed conventional rehabilitation such as orientation and mobility training with a cane or guide dog.
5. Ability to be read and to understand the documentation and procedures of the study.
6. Ability to provide feedback on the use of the BrainPort Vision Pro device.
7. Ability to use basic computer and/or other technologies.
8. 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.
9. Participant or his legal representative willing and able to sign informed consent.
Exclusion Criteria
2. History of tongue damage resulting in sensitivity problems or impaired language.
3. Visible open sores, herpes, abrasions, blisters or rashes on the tongue or numbness of the tongue.
4. Piercings on the tongue.
5. Planned or recent oral surgery (in the last 3 months) and/or dental care (excluding oral check-ups or routine scaling).
6. Known neuropathy of the language or sensory system.
7. History of seizures or epilepsy.
8. 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.
9. Implanted medical devices (e.g., pacemaker, deep brain stimulation device, cochlear implant).
10. Any hearing impairment that prevents you from hearing the device's announcements.
11. Cognitive impairment detected on the basis of medical history and/or during a cognitive impairment telephone interview.
12. Expected or ongoing participation in another clinical trial or any research that may interfere with this study.
13. Known allergy to nickel, gold or a stainless-steel component.
14. Any health condition that may interfere with the study's evaluations.
15. 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.
16. Person deemed unfit to participate in the study by the lead investigator for any other previously cited reason.
17. Adults who do not have the ability to provide valid informed consent (under legal protection)
8 Years
ALL
Yes
Sponsors
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Wicab
INDUSTRY
Responsible Party
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Principal Investigators
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Patricia Grant, Ph.D.
Role: STUDY_DIRECTOR
Wicab, Inc.
Isabelle Audo, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
National Hospital for Ophthalmology of the Fifteen-Vingts
Locations
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University Hospital La Timone
Marseille, , France
CHU de Montpellier
Montpellier, , France
University Hospital of Nantes
Nantes, , France
Institut Aramav
Nîmes, , France
Fondation hospitalière Sainte-Marie
Paris, , France
Necker-Enfants Malades Hospital
Paris, , France
Hôpitaux Universitaires de Strasbourg, Reference Center for Rare Disorders in Ophthalmic Genetics
Strasbourg, , France
Countries
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Central Contacts
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Facility Contacts
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Danièle Denis, M.D.
Role: primary
Isabelle Meunier, M.D.
Role: primary
Michel Weber, M.D.
Role: primary
Luc Jeanjean, M.D.
Role: primary
Pierre, M.D.
Role: primary
M.D.
Role: backup
Dominique Bremond-Gignac, M.D.
Role: primary
Hélène Dollfus, M.D., Ph.D.
Role: primary
Related Links
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Sponsor website, description of BrainPort Vision Pro
Other Identifiers
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2020-WIFR-8313
Identifier Type: -
Identifier Source: org_study_id