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

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.

Study Overview

• Status: Recruiting
• Conditions: Blindness
• Intervention / Treatment: Device: BrainPort Vision Pro

• Study Type: Interventional
• Enrollment (Anticipated): 125
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patricia Grant, Ph.D.; Phone Number: 312-447-3234; Email: pgrant@wicab.com

Study Locations

• France
  • Marseille, France
    • Not yet recruiting
    • University hospital La Timone
    • Contact: Danièle Denis, M.D.; Phone Number: 04 91 38 54 68; Email: daniele.denis@ap-hm.fr
    • Principal Investigator: Danièle Denis, M.D.
  • Montpellier, France
    • Not yet recruiting
    • CHU de Montpellier
    • Contact: Isabelle Meunier, M.D.; Phone Number: 04 67 33 02 78; Email: msg@chu-montpellier.fr
    • Principal Investigator: Isabelle Meunier, M.D.
  • Nantes, France
    • Not yet recruiting
    • University Hospital of Nantes
    • Contact: Michel Weber, M.D.; Phone Number: 02 40 08 36 56; Email: miweber@chu-nantes.fr
    • Principal Investigator: Michel Weber, M.D.
  • Nimes, France
    • Recruiting
    • Institut Aramav
    • Contact: Luc Jeanjean, M.D.; Phone Number: 04 66 23 48 55; Email: Luc.Jeanjean@chu-nimes.fr
    • Principal Investigator: Luc Jeanjean, M.D.
  • Paris, France
    • Recruiting
    • Fondation Hospitalière Sainte-Marie
    • Contact: Pierre, M.D.; Phone Number: 06 83 85 57 63
    • Principal Investigator: Pierre Safar, M.D.
  • Paris, France
    • Recruiting
    • Necker-Enfants Malades Hospital
    • Contact: Dominique Bremond-Gignac, M.D.; Phone Number: 01 44 49 54 43; Email: dominique.bremond@aphp.fr
    • Principal Investigator: Dominique Bremond-Gignac, M.D.
  • Strasbourg, France
    • Recruiting
    • Hôpitaux Universitaires de Strasbourg, Reference Center for Rare Disorders in Ophthalmic Genetics
    • Contact: Hélène Dollfus, M.D., Ph.D.; Phone Number: 03 88 12 81 20; Email: helene.dollfus@chru-strasbourg.fr
    • Principal Investigator: Hélène Dollfus, M.D., Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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
Character identification	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.	Baseline
Orientation and mobility tasks	This task will measure participants' ability to navigate a room and identify distinct objects and features in their environment, such as windows and doorways.	Baseline
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.	3 months
Character identification	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 months
Orientation and mobility tasks	This task will measure participants' ability to navigate a room and identify distinct objects and features in their environment, such as windows and doorways.	3 months
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.	6 months
Character identification	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 months
Orientation and mobility tasks	This task will measure participants' ability to navigate a room and identify distinct objects and features in their environment, such as windows and doorways.	6 months
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.	12 months
Character identification	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 months
Orientation and mobility tasks	This task will measure participants' ability to navigate a room and identify distinct objects and features in their environment, such as windows and doorways.	12 months
Impact of Vision Impairment-Very Low Vision Quality of Life Scale	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.	Baseline
Impact of Vision Impairment-Very Low Vision Quality of Life Scale,	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.	3 months
Impact of Vision Impairment-Very Low Vision Quality of Life Scale,	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.	6 months
Impact of Vision Impairment-Very Low Vision Quality of Life Scale,	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.	12 months
Adverse events related to device or study procedures	Safety	12 months

Collaborators and Investigators

• Sponsor: Wicab
• Investigators: Study Director: Patricia Grant, Ph.D., Wicab, Inc.; Principal Investigator: Isabelle Audo, Ph.D., National Hospital for Ophthalmology of the Fifteen-Vingts

Publications and helpful links

Helpful Links

• Sponsor website, description of BrainPort Vision Pro

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Anticipated): September 30, 2022
• Study Completion (Anticipated): September 30, 2022

Study Registration Dates

• First Submitted: January 15, 2021
• First Submitted That Met QC Criteria: January 22, 2021
• First Posted (Actual): January 27, 2021

Study Record Updates

• Last Update Posted (Actual): November 10, 2021
• Last Update Submitted That Met QC Criteria: November 9, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: visual impairment; blindness; assistive technology; brainport; brainport vision pro; assistive device
• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Sensation Disorders; Vision Disorders; Blindness
• Other Study ID Numbers: 2020-WIFR-8313

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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