NCT04171934

Brief Summary

The main purpose of this study is to validate the ability of the Nelli system (video-based epilepsy examination system) to detect epileptic motor seizure behaviors in patients at rest.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
182

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 17, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 21, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2021

Completed
Last Updated

October 13, 2022

Status Verified

October 1, 2022

Enrollment Period

2 years

First QC Date

November 12, 2019

Last Update Submit

October 8, 2022

Conditions

Epilepsy; Seizure

Outcome Measures

Primary Outcomes (1)

  • FDR (per hour) and TPR

    False detection rate (FDR/hour) as well as true positive rate (TPR) of the Nelli service is to be evaluated. Here FDR stands for detections which do not intersect with the ground truth events, and true positive events match ground truth with the Nelli detections.

    Examination period specific to the patient (1-4 days)

Secondary Outcomes (3)

  • Latency (seconds)

    Examination period specific to the patient (1-4 days)

  • Inter-rater agreement (Cohen's kappa coefficient)

    Examination period specific to the patient (1-4 days)

  • Performance of the algorithmic component

    Examination period specific to the patient (1-4 days)

Study Arms (2)

Adults

Subjects 22+ years of age

Pediatric

Subjects less than 22 years of age

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

90 epilepsy patients of various ages undergoing a standard VEEG examination for clinical evaluation in either one of the following medical facilities: Danish Epilepsy Center (Filadelfia) or Aarhus University Hospital.

You may qualify if:

  • Patients with epilepsy undergoing a standard VEEG examination for clinical evaluation consenting to participate in the present study

You may not qualify if:

  • Patients not consenting to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Danish Epilepsy Center, Filadelfia

Dianalund, Denmark

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Week
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of Neurology

Study Record Dates

First Submitted

November 12, 2019

First Posted

November 21, 2019

Study Start

June 17, 2019

Primary Completion

July 2, 2021

Study Completion

December 15, 2021

Last Updated

October 13, 2022

Record last verified: 2022-10

Locations

DK(1)