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The study is designed to collect data that will aid in future scientific and engineering exploration of correlations between clinical assessments and BNA scores. The results are primarily intended for scientific inquiry and engineering development purposes, and may be used in future regulatory submissions.
A multi-center study in which subjects that had completed or are completing a BNA test with the Auditory Oddball task (or other tests that will be commercially cleared at any given time), will have the option to complete additional investigational tasks and optional clinical assessments and questionnaire forms. At each site, these additional assessments will be suggested by the site's study doctor or clinician and will be collected with the site's ePRO device. The study will include up to 10,000 subjects which had completed or will complete a standard BNA test. Authorized personnel will offer the subjects to participate in the study immediately after testing or contacting subjects that had completed the test in the past. Procedure of consent will be performed by the PI or delegates.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subject who completed or will complete a BNA test |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brain Network Activation (BNAâ„¢) technology | Device | The BNAâ„¢ technology was developed and is utilized by ElMindA Ltd. The BNA Analysis System is cleared for use by qualified medical professionals for the post hoc statistical analysis of the human electroencephalogram ("EEG"), utilizing evoked response potentials ("ERP'). This device is indicated for use in individuals 14 to 24 years of age. The BNA Analysis System is to be used with the auditory oddball task only. |
| Measure | Description | Time Frame |
|---|---|---|
| Engineering development according to clinical assessments | The study is designed to collect data that will aid in future scientific and engineering exploration of correlations between clinical assessments and BNA scores. The results are primarily intended for scientific inquiry and engineering development purposes, and may be used in future regulatory submissions. | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects who completed or will complete a BNA test with the Auditory Oddball Task, from both genders, aged 8-99 years.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liran Korine | Contact | +972-9-9516476 | Liran@elminda.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kadima Neuopsychiatry Institute | Completed | La Jolla | California | 92037 | United States | |
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|
| Collaborative Behavioral Health, LLC |
| Recruiting |
| Chicago |
| Illinois |
| 60612 |
| United States |
|
| Collaborative Behavioral Health, LLC | Recruiting | Skokie | Illinois | 60076 | United States |
|
| Alivation Health, LLC | Completed | Lincoln | Nebraska | 68526 | United States |
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D009422 | Nervous System Diseases |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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