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 @ 4:32 AM
Ignite Modification Date:
2025-12-25 @ 4:32 AM
NCT ID:
NCT02393118
Eligibility Criteria:
Inclusion Criteria:
1. A minimum age of 18 years at enrollment.
2. A documented vision diagnosis of light perception or worse bilaterally.
3. Blinded by traumatic injury (i.e., ocular or cortical trauma).
4. Minimum post 12 months diagnosis of blindness.
5. Previous completion of conventional rehabilitation such as orientation and mobility training with a cane or guide dog.
6. Ability to read (or have read to them) and understand study documents and procedures.
7. Ability to provide valid feedback regarding use of the BrainPort device.
8. Access to an accessible computer and internet connection.
9. Willing and able to complete all questionnaires, telephone conferences, device training, and study procedures required by the protocol, after completing an orientation period with the device.
10. Ability to operate a tablet computer.
Exclusion Criteria:
1. Current oral health problems determined by the participant's medical history and an examination of the oral cavity performed by study personnel.
2. History of injury to the tongue resulting in impaired sensation of use of the tongue.
3. Visible open lesions, cold sores, abrasions, blisters, or rash on the tongue, numbness or lack of feeling of the tongue.
4. Piercings on the tongue.
5. Recent or planned oral surgery and/or dental work in the past three months (does not include routine dental health exams/cleanings).
6. Known neuropathies of the tongue or tactile system.
7. History of seizures or epilepsy.
8. If female, pregnant or breast feeding by self-report. Women of child bearing potential must agree to use appropriate birth control to prevent pregnancy for the duration of the study.
9. People with implanted medical devices (i.e., pacemaker, deep brain stimulator, cochlear implant).
10. Any hearing impairments which prevents hearing the device announcements.
11. Any cognitive disabilities (such as Alzheimer's disease), as determined by medical history and/or the Telephone Inventory Cognitive Screening (TICS).
12. Participation in any other clinical trial or research while my confound results in either study.
13. Known allergy to nickel, gold, or any component of stainless steel.
14. Any medical condition that would interfere with performance on the assessments.
15. The Site Principal Investigator does not deem the candidate to be suitable for the study for other reasons not listed above.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02393118
Study Brief:
Protocol Section:
NCT02393118