Last updated: November 9, 2021
Sponsor: Wicab
Overall Status: Active - Recruiting
Phase
N/A
Condition
Vision Loss
Treatment
N/AClinical Study ID
NCT04725760
2020-WIFR-8313
Ages > 8 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 8 years of age or older
- Diagnosis of profound blindness with residual vision limited to a perception of lightor lower in both eyes.
- Minimum post 12 months diagnosis of blindness
- Previously completed conventional rehabilitation such as orientation and mobilitytraining 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, undergodevice training and carry out all study procedures, after having passed theorientation phase with the device.
- Participant or his legal representative willing and able to sign informed consent.
Exclusion
Exclusion Criteria:
- Ongoing oral disorders determined on the basis of the participant's medical historyand/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 ofthe tongue.
- Piercings on the tongue.
- Planned or recent oral surgery (in the last 3 months) and/or dental care (excludingoral 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 shouldconsent to the use of appropriate contraception to avoid pregnancy during the studyperiod.
- Implanted medical devices (e.g., pacemaker, deep brain stimulation device, cochlearimplant).
- Any hearing impairment that prevents you from hearing the device's announcements.
- Cognitive impairment detected on the basis of medical history and/or during acognitive impairment telephone interview.
- Expected or ongoing participation in another clinical trial or any research that mayinterfere 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 whorefuses to continue to participate in the study after passing the initial trainingphase with the device.
- Person deemed unfit to participate in the study by the lead investigator for any otherpreviously cited reason.
- Adults who do not have the ability to provide valid informed consent (under legalprotection)
Study Design
Total Participants: 125
Study Start date:
October 01, 2020
Estimated Completion Date:
September 30, 2022
Connect with a study center
University Hospital La Timone
Marseille,
FranceSite Not Available
CHU de Montpellier
Montpellier,
FranceSite Not Available
University Hospital of Nantes
Nantes,
FranceSite Not Available
Institut Aramav
Nimes,
FranceActive - Recruiting
Fondation hospitalière Sainte-Marie
Paris,
FranceActive - Recruiting
Necker-Enfants Malades Hospital
Paris,
FranceActive - Recruiting
Hôpitaux Universitaires de Strasbourg, Reference Center for Rare Disorders in Ophthalmic Genetics
Strasbourg,
FranceActive - Recruiting
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