NCT05520476

Neuroliten MVP System Clinical Observation Study

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Enliten AI · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DEVICE	Neuroliten MVP system	The Neuroliten MVP system will be an App that gets uploaded to the patients iPhone from the App Store.

Timeline

• Start date: 2022-10-31
• Primary completion: 2024-11-01
• Completion: 2024-12-01
• First posted: 2022-08-30
• Last updated: 2024-08-27

Locations

1 site across 1 country: United States