Clinical trial NCT05520476: Neuroliten MVP System Clinical Observation Study
Official title: Neuroliten MVP System Clinical Observation Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Epilepsy
Keywords: Seizures
Lead sponsor: Enliten AI
Sponsor class: INDUSTRY
Collaborators: name: CSSi Life Sciences
First posted: 2022-08-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a documented history of at least 2 seizures per week.

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. An Institutional Review Board (IRB) approved informed consent is signed and dated before any study-related activities.
2. Male and female subjects ages 18 to 75, inclusive.
3. Documented history of at least two (2) seizures per week. Seizures can be generalized and/or focal.
4. Diagnosed with intractable or refractory epilepsy.
5. 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.
6. Have implanted vagus nerve stimulation (VNS).
7. Have the ability to understand the requirements of the study and are willing to comply with all study requirements.
8. Must have a working Apple iPhone.

Exclusion Criteria:

1. Women who are either pregnant or breastfeeding.
2. Subjects unable/unwilling to wear the Apple Watch and EEG Wearable for extended periods.
3. Requires the use of a ventilator.
4. Requires the use of supplemental oxygen.
5. Uses a pacemaker or other electronic neurostimulator, except the VNS.
6. Any medical or surgical condition that in the opinion of the investigator may interfere with participation in the study.

Primary outcomes:
measure: Heart Rate
timeFrame: 90 days
measure: Oxygen Saturation
timeFrame: 90 days
measure: Respiratory Rate
timeFrame: 90 days
measure: Blood Pressure
timeFrame: 90 days
measure: Temperature
timeFrame: 90 days
measure: Brain Signals
timeFrame: 90 Days
Secondary outcomes:
measure: Clinical Observations from Caregiver
timeFrame: 90 days
Other outcomes:
Locations:
city: Loveland
country: United States
facility: University of Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Barbara Hager, MD
role: PRINCIPAL_INVESTIGATOR
References: