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

Wicab125 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

125

Conditions

Blindness

Interventions

BrainPort Vision ProDEVICE

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.

Eligibility

Sex: ALLMin age: 8 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (7)

University Hospital La Timone

Marseille, France

NOT_YET_RECRUITING

CHU de Montpellier

Montpellier, France

NOT_YET_RECRUITING

University Hospital of Nantes

Nantes, France

Outcomes

Primary Outcomes

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)

Time frame: 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)

Time frame: 3 months

Visual Function

Time frame: 6 months

Visual Function

Time frame: 12 months

Secondary Outcomes

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.

Time frame: Baseline

Character identification

Central Contacts

Patricia Grant, Ph.D.

CONTACT

312-447-3234 pgrant@wicab.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Institut Aramav

Nîmes, France

RECRUITING

Fondation hospitalière Sainte-Marie

Paris, France

RECRUITING

Necker-Enfants Malades Hospital

Paris, France

RECRUITING

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

Strasbourg, France

RECRUITING

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.

Time frame: 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.

Time frame: Baseline

Object recognition

Time frame: 3 months

Character identification

Time frame: 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.

Time frame: 3 months

Object recognition

Time frame: 6 months

Character identification

Time frame: 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.

Time frame: 6 months

Object recognition

Time frame: 12 months

Character identification

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 12 months

Adverse events related to device or study procedures

Safety

Time frame: 12 months