Clinical trial NCT04725760: Evaluation of the Efficacy of the BrainPort Vision Pro on the Performance of Daily Activities in the Profoundly Blind French Population
Official title: Evaluation of the Efficacy of the BrainPort Vision Pro on the Performance of Daily Activities in the Profoundly Blind French Population
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Blindness
Keywords: blindness
brainport
brainport vision pro
assistive device
assistive technology
visual impairment
Lead sponsor: Wicab
Sponsor class: INDUSTRY
First posted: 2021-01-27
Enrollment: 125
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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 residual vision limited to light perception or less in both eyes.


Eligibility criteria: Inclusion Criteria:

1. 8 years of age or older
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:

1. 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.
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)

Primary outcomes:
measure: Visual Function
timeFrame: Baseline
measure: Visual Function
timeFrame: 3 months
measure: Visual Function
timeFrame: 6 months
measure: Visual Function
timeFrame: 12 months
Secondary outcomes:
measure: Object recognition
timeFrame: Baseline
measure: Character identification
timeFrame: Baseline
measure: Orientation and mobility tasks
timeFrame: Baseline
measure: Object recognition
timeFrame: 3 months
measure: Character identification
timeFrame: 3 months
measure: Orientation and mobility tasks
timeFrame: 3 months
measure: Object recognition
timeFrame: 6 months
measure: Character identification
timeFrame: 6 months
measure: Orientation and mobility tasks
timeFrame: 6 months
measure: Object recognition
timeFrame: 12 months
measure: Character identification
timeFrame: 12 months
measure: Orientation and mobility tasks
timeFrame: 12 months
measure: Impact of Vision Impairment-Very Low Vision Quality of Life Scale
timeFrame: Baseline
measure: Impact of Vision Impairment-Very Low Vision Quality of Life Scale,
timeFrame: 3 months
measure: Impact of Vision Impairment-Very Low Vision Quality of Life Scale,
timeFrame: 6 months
measure: Impact of Vision Impairment-Very Low Vision Quality of Life Scale,
timeFrame: 12 months
measure: Adverse events related to device or study procedures
timeFrame: 12 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: University Hospital La Timone
city: Montpellier
country: France
facility: CHU de Montpellier
city: Nantes
country: France
facility: University Hospital of Nantes
city: Nimes
country: France
facility: Institut Aramav
city: Paris
country: France
facility: Fondation hospitalière Sainte-Marie
city: Paris
country: France
facility: Necker-Enfants Malades Hospital
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg, Reference Center for Rare Disorders in Ophthalmic Genetics
Study officials:
affiliation: Wicab, Inc.
name: Patricia Grant, Ph.D.
role: STUDY_DIRECTOR
affiliation: National Hospital for Ophthalmology of the Fifteen-Vingts
name: Isabelle Audo, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: