Neuroliten MVP System Clinical Observation Study

Epilepsy Clinical Trial

Official title:

Neuroliten MVP System Clinical Observation Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05520476
• Other study ID #: EL-001
• Status: Recruiting
• Start date: October 31, 2022
• Est. completion date: April 2024

Study information

• Verified date: September 2023
• Source: Enliten AI
• Contact: Himanshu Misra, PhD
• Phone: 408-483-1742
• Email: himanshu[@]enlitenai.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy

Intervention

Device:
• Neuroliten MVP system
The Neuroliten MVP system will be an App that gets uploaded to the patients iPhone from the App Store.

Locations

Country	Name	City	State
United States	University of Colorado	Loveland	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Enliten AI	CSSi Life Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart Rate	Heart Rate (beats per minute)	90 days
Primary	Oxygen Saturation	Oxygen Saturation (SpO2 %)	90 days
Primary	Respiratory Rate	Respiratory Rate (breaths per minute)	90 days
Primary	Blood Pressure	Blood Pressure (mmHg)	90 days
Primary	Temperature	Temperature (Fahrenheit)	90 days
Primary	Brain Signals	Brain signals obtained using a 14-channel EEG Wearable	90 Days
Secondary	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