A Study of Detection of Paroxysmal Events Utilizing Computer Vision and Machine Learning - Nelli

NCT05606575 | Completed FDA Device

• 1 other identifier: 21-08296-XP
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Epilepsy

Outcome Measures

Primary Outcomes (1)

• Sensitivity of a seizure detection system

  To show that Nelli is able to correctly identify each category of seizures separately (Category I, II, and III) and all seizures categories combined with a sensitivity of at least 70%. Hypotheses will be tested sequentially (all seizures combined, Category I, then Category II, then Category III), each with a significance level of 2.5%, and will continue until the first hypothesis is not rejected. For each detected abnormal event, the probability is calculated and concluded as seizure/non- seizure using predefined threshold values, pre-trained seizure detection library, and probability of that event. The time-points are reported automatically into the Dashboard of Nelli. Statistical analyses will be performed to calculate true and false positive and negative detection rates.

  During routine video-EEG monitoring, up to 14 days

Interventions

Nelli DEVICE

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.

Eligibility Criteria

• Age: 6 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients aged 6-21 with history (or suspected history) of motor seizures that are undergoing video-EEG monitoring for routine clinical care.

You may qualify if:

• Subject shall sign informed consent.
• Subject is between 6 and 21 years.
• Subjects shall be undergoing video-EEG monitoring for routine clinical purposes.
• Subjects shall have a suspected history of motor seizures.
• Subject shall be able to understand and sign written informed consent or have a legally authorized representative (LAR) who can do so, prior to the performance of any study assessments.

You may not qualify if:

• None identified.

Sponsors & Collaborators

• Neuro Event Labs Inc.: lead

Study Sites (1)

The University of Tennessee Health Science Center

Memphis, Tennessee, 38163, United States

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• James Wheless, MD

  The University of Tennessee Health Science Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: November 4, 2022
• Study Start: August 1, 2022
• Primary Completion: December 31, 2025
• Study Completion: January 31, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)