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

Blindness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04725760
• Other study ID #: 2020-WIFR-8313
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: September 30, 2022

Study information

• Verified date: January 2021
• Source: Wicab
• Contact: Patricia Grant, Ph.D.
• Phone: 312-447-3234
• Email: pgrant[@]wicab.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Blindness

Intervention

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.

Locations

Country	Name	City	State
France	University Hospital La Timone	Marseille
France	CHU de Montpellier	Montpellier
France	University Hospital of Nantes	Nantes
France	Institut Aramav	Nimes
France	Fondation hospitalière Sainte-Marie	Paris
France	Necker-Enfants Malades Hospital	Paris
France	Hôpitaux Universitaires de Strasbourg, Reference Center for Rare Disorders in Ophthalmic Genetics	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
Wicab

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Adverse events related to device or study procedures	Safety	12 months

External Links

•   Sponsor website, description of BrainPort Vision Pro