Neuroliten MVP System Clinical Observation Study
1 other identifier
observational
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2022
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 23, 2022
CompletedFirst Posted
Study publicly available on registry
August 30, 2022
CompletedStudy Start
First participant enrolled
October 31, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedAugust 27, 2024
August 1, 2024
2 years
August 23, 2022
August 26, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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 Outcomes (1)
Clinical Observations from Caregiver
90 days
Study Arms (1)
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.
Interventions
The Neuroliten MVP system will be an App that gets uploaded to the patients iPhone from the App Store.
Eligibility Criteria
Patients with a documented history of at least 2 seizures per week.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Enliten AIlead
- CSSi Life Sciencescollaborator
Study Sites (1)
University of Colorado
Loveland, Colorado, 80538, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Barbara Hager, MD
University of Colorado, Denver
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 23, 2022
First Posted
August 30, 2022
Study Start
October 31, 2022
Primary Completion
November 1, 2024
Study Completion
December 1, 2024
Last Updated
August 27, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share