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

November 9, 2021 updated by: Wicab
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
125

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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:
        • Principal Investigator:
          • Danièle Denis, M.D.
      • Montpellier, France
        • Not yet recruiting
        • CHU de Montpellier
        • Contact:
        • Principal Investigator:
          • Isabelle Meunier, M.D.
      • Nantes, France
        • Not yet recruiting
        • University Hospital of Nantes
        • Contact:
        • Principal Investigator:
          • Michel Weber, M.D.
      • Nimes, France
        • Recruiting
        • Institut Aramav
        • Contact:
        • 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:
        • Principal Investigator:
          • Dominique Bremond-Gignac, M.D.
      • Strasbourg, France
        • Recruiting
        • Hôpitaux Universitaires de Strasbourg, Reference Center for Rare Disorders in Ophthalmic Genetics
        • Contact:
        • Principal Investigator:
          • Hélène Dollfus, M.D., Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Baseline
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 months
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)
6 months
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)
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
Baseline
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.
Baseline
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.
3 months
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.
3 months
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.
3 months
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.
6 months
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.
6 months
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.
6 months
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.
12 months
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 months
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.
12 months
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.
Baseline
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.
3 months
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.
6 months
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.
12 months
Adverse events related to device or study procedures
Time Frame: 12 months
Safety
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wicab

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 15, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 27, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 10, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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