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ClinicalTrials.gov ID

NCT04725760

Lead Sponsor

WicabINDUSTRY

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

125Estimated

Last Update Posted

Nov 10, 2021Actual

Start Date

Oct 1, 2020Actual

Primary Completion Date

Sep 30, 2022Estimated

Completion Date

Sep 30, 2022Estimated

Official Title

Evaluation of the Efficacy of the BrainPort Vision Pro on the Performance of Daily Activities in the Profoundly Blind French Population

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.

• Blindness

• BrainPort Vision Pro

Ages Eligible for Study

Child (0-17)Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Yes

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 Purpose

Supportive Care

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

WicabINDUSTRY

Luc.Jeanjean@chu-nimes.fr04 66 23 48 55