Neuroliten MVP System Clinical Observation Study

Active, not recruiting

• Conditions: Epilepsy

• Registration Number: NCT05520476
• Lead Sponsor: Enliten AI

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.

Study Timeline

• Study First Submitted: 2022-08-23
• Study First Submitted QC: 2022-08-25
• Study First Posted: 2022-08-30
• Study Start: 2022-10-31
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-26
• Last Update Posted: 2024-08-27
• Primary Completion: 2024-11
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Respiratory Rate	90 days	Respiratory Rate (breaths per minute)
Heart Rate	90 days	Heart Rate (beats per minute)
Oxygen Saturation	90 days	Oxygen Saturation (SpO2 %)
Blood Pressure	90 days	Blood Pressure (mmHg)
Temperature	90 days	Temperature (Fahrenheit)
Brain Signals	90 Days	Brain signals obtained using a 14-channel EEG Wearable

Secondary Outcome Measures

Name	Time	Method
Clinical Observations from Caregiver	90 days	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)

Trial Locations

Locations (1)

University of Colorado; 🇺🇸 Loveland, Colorado, United States