Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Filadelfia Epilepsy Hospital | OTHER |
| Aarhus University Hospital | OTHER |
| Neuro Event Labs Oy | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Proper seizure documentation is an important tool to evaluate treatment outcomes and risks associated with epileptic seizures. Apart from a costly in-hospital video electro-encephalogram (VEEG) monitoring, most patients with epilepsy log and track their seizures with the help of the seizure diaries only. However, the reliability of the diaries is heavily dependent on an accurate recognition and recording of the seizures. There is an obvious need for a more objective and reliable seizure detection method. The investigators propose a low-cost video-based examination system, designed to detect motor seizure behaviors in patients at rest.
The main aim of this study is to clinically validate the ability of the Nelli system (video-based epilepsy examination system) to detect epileptic motor seizure behaviors in patients at rest, using simultaneous VEEG as the ground truth with the reference to all motor seizures and individual motor seizure types.
Study design established as follows:
Study population is represented by 90 epilepsy patients with suspected history of motor seizures undergoing a standard VEEG examination for clinical evaluation of epilepsy.
Co-registration of standard VEEG with the Nelli video- and audio-based system is performed, duration of the registration is 1-4 days.
The inclusion criteria for seizures:
The registrations are analyzed by the Nelli system blinded to any clinical information. Nelli system consists of two evaluation components:
Reports containing the seizure type classification (time-stamped) are provided by the VEEG laboratory, the performance of the Nelli system is assessed using these reports as the ground truth.
a. Specificity and sensitivity of the Nelli system are evaluated with reference to both all motor seizures and individual motor seizure types.
The secondary outcome measures are established as follows:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adults | Subjects 22+ years of age | ||
| Pediatric | Subjects less than 22 years of age |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Latency (seconds) | Latency from the seizure onset (according to the ground truth) and the seizure detection by the Nelli system. | Examination period specific to the patient (1-4 days) |
| Inter-rater agreement (Cohen's kappa coefficient) |
Not provided
Inclusion Criteria:
Patients with epilepsy undergoing a standard VEEG examination for clinical evaluation consenting to participate in the present study
Exclusion Criteria:
Patients not consenting to participate in the study
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Danish Epilepsy Center, Filadelfia | Dianalund | Denmark |
Not provided
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Inter-rater agreement for the supervisory component of the Nelli system
| Examination period specific to the patient (1-4 days) |
| Performance of the algorithmic component | Performance of the algorithmic component evaluated using the ROC (receiver operating characteristic) curve at different operating points (thresholds). | Examination period specific to the patient (1-4 days) |