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

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ClinicalTrials.gov Identifier: NCT04725760
Recruitment Status : Recruiting
First Posted : January 27, 2021
Last Update Posted : November 10, 2021
Sponsor:
Information provided by (Responsible Party):
Wicab

Study Description
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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.

Condition or disease Intervention/treatment Phase
Blindness Device: BrainPort Vision Pro Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluation of the Efficacy of the BrainPort Vision Pro on the Performance of Daily Activities in the Profoundly Blind French Population
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : September 30, 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: Single Group Assisgnment Device: BrainPort Vision Pro

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.


Outcome Measures
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Primary Outcome Measures :
  1. Visual Function [ Time Frame: Baseline ]
    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)

  2. Visual Function [ Time Frame: 3 months ]
    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. Visual Function [ Time Frame: 6 months ]
    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)

  4. Visual Function [ Time Frame: 12 months ]
    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)


Secondary Outcome Measures :
  1. Object recognition [ Time Frame: Baseline ]
    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.

  2. Character identification [ Time Frame: Baseline ]
    High contrast letters and numbers will be presented. Subjects will be required to orally identify each letter or number presented. The total number of correct answers will be recorded. Ten individual letters/numbers will be presented.

  3. Orientation and mobility tasks [ Time Frame: Baseline ]
    This task will measure participants' ability to navigate a room and identify distinct objects and features in their environment, such as windows and doorways.

  4. Object recognition [ Time Frame: 3 months ]
    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.

  5. Character identification [ Time Frame: 3 months ]
    High contrast letters and numbers will be presented. Subjects will be required to orally identify each letter or number presented. The total number of correct answers will be recorded. Ten individual letters/numbers will be presented.

  6. Orientation and mobility tasks [ Time Frame: 3 months ]
    This task will measure participants' ability to navigate a room and identify distinct objects and features in their environment, such as windows and doorways.

  7. Object recognition [ Time Frame: 6 months ]
    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.

  8. Character identification [ Time Frame: 6 months ]
    High contrast letters and numbers will be presented. Subjects will be required to orally identify each letter or number presented. The total number of correct answers will be recorded. Ten individual letters/numbers will be presented.

  9. Orientation and mobility tasks [ Time Frame: 6 months ]
    This task will measure participants' ability to navigate a room and identify distinct objects and features in their environment, such as windows and doorways.

  10. Object recognition [ Time Frame: 12 months ]
    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.

  11. Character identification [ Time Frame: 12 months ]
    High contrast letters and numbers will be presented. Subjects will be required to orally identify each letter or number presented. The total number of correct answers will be recorded. Ten individual letters/numbers will be presented.

  12. Orientation and mobility tasks [ Time Frame: 12 months ]
    This task will measure participants' ability to navigate a room and identify distinct objects and features in their environment, such as windows and doorways.

  13. Impact of Vision Impairment-Very Low Vision Quality of Life Scale [ Time Frame: Baseline ]
    A vision-related quality of life scale for participants with very low vision 28 items on a Likert scale, ranging from 1-3 with higher scores indicating better vision-related quality of life.

  14. Impact of Vision Impairment-Very Low Vision Quality of Life Scale, [ Time Frame: 3 months ]
    A vision-related quality of life scale for participants with very low vision 28 items on a Likert scale, ranging from 1-3 with higher scores indicating better vision-related quality of life.

  15. Impact of Vision Impairment-Very Low Vision Quality of Life Scale, [ Time Frame: 6 months ]
    A vision-related quality of life scale for participants with very low vision 28 items on a Likert scale, ranging from 1-3 with higher scores indicating better vision-related quality of life.

  16. Impact of Vision Impairment-Very Low Vision Quality of Life Scale, [ Time Frame: 12 months ]
    A vision-related quality of life scale for participants with very low vision 28 items on a Likert scale, ranging from 1-3 with higher scores indicating better vision-related quality of life.

  17. Adverse events related to device or study procedures [ Time Frame: 12 months ]
    Safety


Eligibility Criteria
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Ages Eligible for Study:   8 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04725760


Contacts
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Contact: Patricia Grant, Ph.D. 312-447-3234 pgrant@wicab.com

Locations
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France
University Hospital La Timone Not yet recruiting
Marseille, France
Contact: Danièle Denis, M.D.    04 91 38 54 68    daniele.denis@ap-hm.fr   
Principal Investigator: Danièle Denis, M.D.         
CHU de Montpellier Not yet recruiting
Montpellier, France
Contact: Isabelle Meunier, M.D.    04 67 33 02 78    msg@chu-montpellier.fr   
Principal Investigator: Isabelle Meunier, M.D.         
University Hospital of Nantes Not yet recruiting
Nantes, France
Contact: Michel Weber, M.D.    02 40 08 36 56    miweber@chu-nantes.fr   
Principal Investigator: Michel Weber, M.D.         
Institut Aramav Recruiting
Nimes, France
Contact: Luc Jeanjean, M.D.    04 66 23 48 55    Luc.Jeanjean@chu-nimes.fr   
Principal Investigator: Luc Jeanjean, M.D.         
Fondation hospitalière Sainte-Marie Recruiting
Paris, France
Contact: Pierre, M.D.    06 83 85 57 63      
Contact: M.D.         
Principal Investigator: Pierre Safar, M.D.         
Necker-Enfants Malades Hospital Recruiting
Paris, France
Contact: Dominique Bremond-Gignac, M.D.    01 44 49 54 43    dominique.bremond@aphp.fr   
Principal Investigator: Dominique Bremond-Gignac, M.D.         
Hôpitaux Universitaires de Strasbourg, Reference Center for Rare Disorders in Ophthalmic Genetics Recruiting
Strasbourg, France
Contact: Hélène Dollfus, M.D., Ph.D.    03 88 12 81 20    helene.dollfus@chru-strasbourg.fr   
Principal Investigator: Hélène Dollfus, M.D., Ph.D.         
Sponsors and Collaborators
Wicab
Investigators
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Study Director: Patricia Grant, Ph.D. Wicab, Inc.
Principal Investigator: Isabelle Audo, Ph.D. National Hospital for Ophthalmology of the Fifteen-Vingts
More Information
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Additional Information:

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Responsible Party: Wicab
ClinicalTrials.gov Identifier: NCT04725760    
Other Study ID Numbers: 2020-WIFR-8313
First Posted: January 27, 2021    Key Record Dates
Last Update Posted: November 10, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Wicab:
blindness
brainport
brainport vision pro
 assistive device
assistive technology
visual impairment
Additional relevant MeSH terms:
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Blindness
Vision Disorders
Sensation Disorders
 Neurologic Manifestations
Nervous System Diseases
Eye Diseases