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

Last updated: November 9, 2021
Sponsor: Wicab
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vision Loss

Treatment

N/A

Clinical Study ID

NCT04725760
2020-WIFR-8313
  • Ages > 8
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Inclusion Criteria:

  1. 8 years of age or older
  2. Diagnosis of profound blindness with residual vision limited to a perception of lightor lower in both eyes.
  3. Minimum post 12 months diagnosis of blindness
  4. Previously completed conventional rehabilitation such as orientation and mobilitytraining 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, undergodevice training and carry out all study procedures, after having passed theorientation phase with the device.
  9. Participant or his legal representative willing and able to sign informed consent.

Exclusion

Exclusion Criteria:

  1. 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.
  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 ofthe tongue.
  4. Piercings on the tongue.
  5. Planned or recent oral surgery (in the last 3 months) and/or dental care (excludingoral 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 shouldconsent to the use of appropriate contraception to avoid pregnancy during the studyperiod.
  9. Implanted medical devices (e.g., pacemaker, deep brain stimulation device, cochlearimplant).
  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 acognitive impairment telephone interview.
  12. Expected or ongoing participation in another clinical trial or any research that mayinterfere 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 whorefuses to continue to participate in the study after passing the initial trainingphase with the device.
  16. Person deemed unfit to participate in the study by the lead investigator for any otherpreviously cited reason.
  17. 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,
    France

    Site Not Available

  • CHU de Montpellier

    Montpellier,
    France

    Site Not Available

  • University Hospital of Nantes

    Nantes,
    France

    Site Not Available

  • Institut Aramav

    Nimes,
    France

    Active - Recruiting

  • Fondation hospitalière Sainte-Marie

    Paris,
    France

    Active - Recruiting

  • Necker-Enfants Malades Hospital

    Paris,
    France

    Active - Recruiting

  • Hôpitaux Universitaires de Strasbourg, Reference Center for Rare Disorders in Ophthalmic Genetics

    Strasbourg,
    France

    Active - Recruiting

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