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:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-24 @ 11:54 PM
NCT ID:
NCT03438851
Eligibility Criteria:
Inclusion Criteria:
1. Enrolled in but not initiated the ABI Wellness program
2. Male or female, 19-65 years old inclusively
3. Normal hearing capabilities
4. Able to understand the informed consent form, study procedures and willing to participate in study
5. Able to keep eyes still for 6 minutes
Exclusion Criteria:
1. Clinically documented hearing issues (e.g. in-ear hearing problems, punctured ear drum, etc.)
2. Score of 7 or lower on the Mini Mental State Exam (MMSE) - Orientation subscale
3. Implanted pacemaker
4. Metal or plastic implants in skull
5. In-ear hearing aid or cochlear implant, hearing device
6. Recent (within last 6 months) acquired brain injury
7. History of other neurological disorder (e.g. brain cancer, dementia, multiple sclerosis, stroke, etc.)
8. Exposed to investigational drug or device 30 days prior to start in this study, or concurrent use of investigational drug or device while enrolled in this study
9. Not fluent in English language
10. Unable to provide informed consent
11. Previous participation in studies using the NeuroCatch Platform™
12. If female and of child-bearing potential: pregnant, suspected or planning to become pregnant or breast-feeding
13. History of seizures
14. Allergy to rubbing alcohol or EEG gel
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
65 Years
Study:
NCT03438851
Study Brief:
Protocol Section:
NCT03438851