Neuroliten MVP System Clinical Observation Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Neuroliten MVP System Clinical Observation Study

Conditions
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Epilepsy

Intervention / Treatment
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* Device: Neuroliten MVP system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: An Institutional Review Board (IRB) approved informed consent is signed and dated before any study-related activities. Male and female subjects ages 18 to 75, inclusive. Documented history of at least two (2) seizures per week. Seizures can be generalized and/or focal. Diagnosed with intractable or refractory epilepsy. Have a caregiver/family member who stays with the subject, has the ability to detect seizures, and is willing to provide the information needed for the study. Have implanted vagus nerve stimulation (VNS). Have the ability to understand the requirements of the study and are willing to comply with all study requirements. Must have a working Apple iPhone. Exclusion Criteria: Women who are either pregnant or breastfeeding. Subjects unable/unwilling to wear the Apple Watch and EEG Wearable for extended periods. Requires the use of a ventilator. Requires the use of supplemental oxygen. Uses a pacemaker or other electronic neurostimulator, except the VNS. Any medical or surgical condition that in the opinion of the investigator may interfere with participation in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 20 patients with at least two seizures per week.<br>The device collects vital signs and EEG data as well as caregiver information associated with seizure episodes. | Device: Neuroliten MVP system<br>* The Neuroliten MVP system will be an App that gets uploaded to the patients iPhone from the App Store.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Observations from Caregiver | Caregiver will log details of specific seizure episodes with the following measures: Date, Time and Duration of Seizure Type of seizure (if known) Caregiver's assessment of severity (1-10, 10 being very severe) Cluster of seizures (How many were observed and interval) | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Seizures