Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-25 @ 2:08 AM
NCT ID:
NCT04725760
Eligibility Criteria:
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)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
8 Years
Study:
NCT04725760
Study Brief:
Protocol Section:
NCT04725760