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

November 22, 2024 updated by: Neuro Event Labs Inc.

Increased computational power has made it possible to implement complex image recognition tasks and machine learning to be implemented in every day usage. The computer vision and machine learning based solution used in this project (Nelli) is an automatic seizure detection and reporting method that has a CE mark for this specific use.

The present study will provide data to expand the utility and detection capability of NELLI and enhance the accuracy and clinical utility of automated computer vision and machine learning based seizure detection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, blind comparison to the clinical gold standard for seizure characterization. This study is intended to compare the Nelli Software's ability to identify seizure events to vEEG review in adults with suspected nighttime seizures. Simultaneously, Nelli will continuously record audio and video while video-electroencephalography (vEEG) is recorded per typical standard of care. Events with positive motor manifestations will be independently identified, following standard clinical practice, by three epileptologists using clinical vEEG data. Nelli Software will review the audio and video data and independently identify events with positive motor manifestations. The outcomes of event identification will be compared between Epileptologists and the Nelli Software. For each category of event captured the positive percent agreement will be calculated using the exact binomial method. The primary endpoint of this study is to demonstrate that Nelli is able to identify seizures that have a positive motor component with a sensitivity of > 70%.

Study Type

Observational

Enrollment (Actual)

233

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with suspected motor seizures that are undergoing video-EEG monitoring for routine clinical care.

Description

Inclusion Criteria:

  • All patients undergoing video-EEG monitoring for clinical purposes who are suspected of having seizures.

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of a seizure detection system
Time Frame: During routine seizure monitoring in the hospital - up to one week
The primary outcome measure will be the sensitivity of the Nelli system to detect seizrues with a positive motor component in comparison to independent Neurologist review of vEEG collected in an epilepsy monitoring unit. This is a blinded comparison to the clinical gold standard (vEEG)
During routine seizure monitoring in the hospital - up to one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neuro Event Labs Inc.

Investigators

  • Principal Investigator: Michael Sperling, MD, Jefferson University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2020

Primary Completion (Actual)

November 27, 2022

Study Completion (Actual)

November 27, 2022

Study Registration Dates

First Submitted

January 29, 2021

First Submitted That Met QC Criteria

February 3, 2021

First Posted (Actual)

February 4, 2021

Study Record Updates

Last Update Posted (Estimated)

November 25, 2024

Last Update Submitted That Met QC Criteria

November 22, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TJU-20D.009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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