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The study utilizes investigational software, the SPARK Test, with an FDA-cleared electroencephalography (EEG) amplifier and EEG cap to collect and patient EEG data.
The aim of this study is to collect data to support development of an algorithm to determine whether applying machine-learning techniques to eyes open/eyes closed resting-state electroencephalography (EEG) can characterize patient's cognitive status and detect the presence or absence of AD on the basis of the patient's EEG.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects - Variable Cognitive Status | Other | Subjects meeting Inclusion/Exclusion criteria with open eyes/closed eyes EEG collection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPARK Test | Device | Thirty (30) minutes of resting state EEG data collection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| EEG Data collection for AI software development | Rate of complete software collection per enrolled subjects complete a SPARK Test recording. | During the diagnostic procedure |
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Inclusion Criteria:
Exclusion Criteria:
Unable to remain still for up to 30 minutes during EEG data recording
Subjects currently on and unable to wash out concomitant medications, including: 1) opiates; 2) benzodiazepines and nonbenzodiazepine hypnotics; 3) sedative antihistamines; 4) tricyclic anti-depressants; 5) skeletal muscle relaxants; 6) antiepileptics; 7) antipsychotics; 8) antimanic agents; 9) THC; 10) anticholinergics
Previous history of craniotomy
Medical or psychiatric illness that would interfere with study participation
History of epilepsy or chronic seizure disorder
Presence of non-dental metal in head
Currently experiencing a skin disease on scalp that would affect electrode contacts
Subject meets at least one of the following criteria:
Substance Use Disorder, including Alcohol
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Island Psych | Loma Linda | California | 92318 | United States | ||
| CenExel Rocky Mountain |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Englewood |
| Colorado |
| 80110 |
| United States |
| Renstar Medical | Ocala | Florida | 34470 | United States |
| Arcturus Healthcare PLC, Troy - Internal Medicine Division | Troy | Michigan | 48083 | United States |
| Alivation Health | Lincoln | Nebraska | 68501 | United States |
| Advanced Neuro | El Paso | Texas | 79835 | United States |
| Integrated Neurology | Falls Church | Virginia | 22040 | United States |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |