Neuroliten MVP System Clinical Observation Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Epilepsy
• Intervention / Treatment: Device: Neuroliten MVP system

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.

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Loveland, Colorado, United States, 80538
      • University Of Colorado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with a documented history of at least 2 seizures per week.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: Neuroliten MVP system; The Neuroliten MVP system will be an App that gets uploaded to the patients iPhone from the App Store.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Enliten AI
• Collaborators: CSSi Life Sciences
• Investigators: Principal Investigator: Barbara Hager, MD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2022
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: August 23, 2022
• First Submitted That Met QC Criteria: August 25, 2022
• First Posted (Actual): August 30, 2022

Study Record Updates

• Last Update Posted (Actual): August 27, 2024
• Last Update Submitted That Met QC Criteria: August 26, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Seizures
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: EL-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No