Status:
UNKNOWN
Evaluation of the Efficacy of the BrainPort Vision Pro on the Performance of Daily Activities in the Profoundly Blind French Population
Lead Sponsor:
Wicab
Conditions:
Blindness
Eligibility:
All Genders
8+ years
Phase:
NA
Brief 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 res...
Eligibility Criteria
Inclusion
- 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.
- 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.
Exclusion
- 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.
- 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)
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2022
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT04725760
Start Date
October 1 2020
End Date
September 30 2022
Last Update
November 10 2021
Active Locations (7)
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1
University Hospital La Timone
Marseille, France
2
CHU de Montpellier
Montpellier, France
3
University Hospital of Nantes
Nantes, France
4
Institut Aramav
Nîmes, France