Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| CSSi Life Sciences | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
This is an observational study for data collection from subjects diagnosed with Epilepsy/intractable seizures. The Neuroliten MVP System will not be used for patient management or treatment decisions.
Neuroliten MVP system stores the data obtained from wearables, caregivers, and all audio/video recording of seizure activity that the caregiver captures associated with a seizure episode.
The primary objective of this study is to obtain vital signs and neurological indicators via the Neuroliten MVP System to correlate to the onset of seizures that are detected by the observations of family/caregivers.
The secondary objective is to identify the vital signs and/or neurological indicators that are associated with seizure onset.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 20 patients with at least two seizures per week. | The device collects vital signs and EEG data as well as caregiver information associated with seizure episodes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuroliten MVP system | Device | The Neuroliten MVP system will be an App that gets uploaded to the patients iPhone from the App Store. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate | Heart Rate (beats per minute) | 90 days |
| Oxygen Saturation | Oxygen Saturation (SpO2 %) | 90 days |
| Respiratory Rate | Respiratory Rate (breaths per minute) | 90 days |
| Blood Pressure | Blood Pressure (mmHg) | 90 days |
| Temperature | Temperature (Fahrenheit) | 90 days |
| Brain Signals | Brain signals obtained using a 14-channel EEG Wearable | 90 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Observations from Caregiver | Caregiver will log details of specific seizure episodes with the following measures:
| 90 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Patients with a documented history of at least 2 seizures per week.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Barbara Hager, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado | Loveland | Colorado | 80538 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
Not provided
Not provided
Not provided
Not provided
Not provided
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |