Evaluation of the Efficacy of the BrainPort Vision Pro on... | NCT04725760

NCT04725760

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Label	Type	Description	Intervention Names
Single Group Assisgnment	Experimental		Device: BrainPort Vision Pro

Name	Type	Description	Arm Group Labels	Other Names
BrainPort Vision Pro	Device	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)	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)	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)	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)	12 months

Secondary Outcomes

Measure	Description	Time Frame
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.	Baseline

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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)

Name	Affiliation	Role
Patricia Grant, Ph.D.	Wicab, Inc.	Study Director
Isabelle Audo, Ph.D.	National Hospital for Ophthalmology of the Fifteen-Vingts	Principal Investigator

ID	Term
D001766	Blindness
D014786	Vision Disorders

ID	Term
D012678	Sensation Disorders
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D005128	Eye Diseases