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

NCT04725760 | Unknown DMC FDA Device

• 1 other identifier: 2020-WIFR-8313
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 7

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.

Conditions

Blindness

Keywords

blindness; brainport; brainport vision pro; assistive device; assistive technology; visual impairment

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (17)

• Object recognition

  Baseline

• Character identification

  Baseline

• Orientation and mobility tasks

  Baseline

• Object recognition

  3 months

• Character identification

  3 months

Study Arms (1)

Single Group Assisgnment

EXPERIMENTAL

Device: BrainPort Vision Pro

Interventions

BrainPort Vision Pro DEVICE

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.

Single Group Assisgnment

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Diagnosis of profound blindness with residual vision limited to a perception of light or lower in both eyes.
• Minimum post 12 months diagnosis of blindness
• Previously completed conventional rehabilitation such as orientation and mobility training with a cane or guide dog.
• Ability to be read and to understand the documentation and procedures of the study.
• Ability to provide feedback on the use of the BrainPort Vision Pro device.
• Ability to use basic computer and/or other technologies.
• 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.
• Participant or his legal representative willing and able to sign informed consent.

You may not qualify if:

• 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.
• History of tongue damage resulting in sensitivity problems or impaired language.
• Visible open sores, herpes, abrasions, blisters or rashes on the tongue or numbness of the tongue.
• Piercings on the tongue.
• Planned or recent oral surgery (in the last 3 months) and/or dental care (excluding oral check-ups or routine scaling).
• Known neuropathy of the language or sensory system.
• History of seizures or epilepsy.
• 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.
• Implanted medical devices (e.g., pacemaker, deep brain stimulation device, cochlear implant).
• Any hearing impairment that prevents you from hearing the device's announcements.
• Cognitive impairment detected on the basis of medical history and/or during a cognitive impairment telephone interview.
• Expected or ongoing participation in another clinical trial or any research that may interfere with this study.
• Known allergy to nickel, gold or a stainless-steel component.
• Any health condition that may interfere with the study's evaluations.
• 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.

Sponsors & Collaborators

• Wicab: lead

Study Sites (7)

University Hospital La Timone

Marseille, France

NOT YET RECRUITING

CHU de Montpellier

Montpellier, France

NOT YET RECRUITING

University Hospital of Nantes

Nantes, France

NOT YET RECRUITING

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

Related Links

• Sponsor website, description of BrainPort Vision Pro

MeSH Terms

Conditions

Blindness; Vision Disorders

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Patricia Grant, Ph.D.

  Wicab, Inc.

  STUDY DIRECTOR

• Isabelle Audo, Ph.D.

  National Hospital for Ophthalmology of the Fifteen-Vingts

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia Grant, Ph.D.

CONTACT

312-447-3234; pgrant@wicab.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: January 27, 2021
• Study Start: October 1, 2020
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: November 10, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (7)