A Study of Detection of Paroxysmal Events Utilizing Computer Vision and Machine Learning - Nelli
NCT05606575 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 150
Last updated 2026-02-13
Summary
Nelli is a video-based non-EEG physiological seizure monitoring system. This study is a blinded comparison of Nelli's identified events to gold-standard video EEG review in at-rest pediatric subjects with suspected motor seizures.
Conditions
Interventions
- DEVICE
-
Nelli
Nelli is a non-EEG physiological signal-based seizure detection and quantification device that is indicated for use as an adjunct to seizure monitoring during periods of rest. The device utilizes automated analysis of audio and video (media) data collected via the personal recording unit (PRU) hardware accessory to identify epileptic and non-epileptic seizure events with a positive motor component.
Sponsors & Collaborators
-
Neuro Event Labs Inc.
lead INDUSTRY
Principal Investigators
-
James Wheless, MD · The University of Tennessee Health Science Center
Eligibility
- Min Age
- 6 Years
- Max Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-08-01
- Primary Completion
- 2025-12-31
- Completion
- 2026-01-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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