Epilepsy; SeizureNelliNCT04171934
Clinical Validation of a Video-based Epilepsy Examination Service
An observational study of Epilepsy; Seizure, run by Tampere University at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Epilepsy; Seizure
- How many people
- 182 participants
- Where
- 1 siteDenmark
- Study dates
- 17 Jun 2019to 15 Dec 2021
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Patients with epilepsy undergoing a standard VEEG examination for clinical evaluation consenting to participate in the present study
Who cannot join
- Patients not consenting to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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:
- Epileptic motor seizures appearing from rest while patients are in supine position in their monitoring bed.
- The seizures are determined to be epileptic based on electroclinical characteristics by the responsible neurophysiologist / epileptologist.
- The seizures can be classified into motor seizure types (both focal and generalized) using the 2017 International League Against Epilepsy (ILAE) seizure classification.
- The registrations are analyzed by the Nelli system blinded to any clinical information. Nelli system consists of two evaluation components:
- Algorithmic component (pre-trained machine learning model based on video and audio signals)
- Supervisory component (performed by experienced VEEG technicians)
- 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.
- 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:
- To assess the latency from the onset of the seizure detection by the Nelli system in comparison to VEEG registration.
- To determine an inter-rater agreement for the supervisory component of the Nelli system.
- To investigate the performance of the algorithmic component of the Nelli system alone.
- Conditions
- Epilepsy; Seizure
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adults | Subjects 22+ years of age | |
| Pediatric | Subjects less than 22 years of age |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Examination period specific to the patient (1-4 days)
Secondary outcomes (3)
Latency (seconds)
Latency from the seizure onset (according to the ground truth) and the seizure detection by the Nelli system.
Measured: Examination period specific to the patient (1-4 days)
Inter-rater agreement (Cohen's kappa coefficient)
Inter-rater agreement for the supervisory component of the Nelli system
Measured: 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).
Measured: Examination period specific to the patient (1-4 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start17 Jun 2019
- Primary completion2 Jul 2021
- Study completion15 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy; SeizureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 182 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Tampere University
- Sponsor type
- University, hospital or other
- Collaborators
- Filadelfia Epilepsy Hospital, Aarhus University Hospital, Neuro Event Labs Oy
- Responsible party
- Principal investigator, Jukka Peltola, Tampere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04171934
- Sponsor's protocol ID
- CS001
- Acronym
- Nelli
- Status last verified
- Oct 2022
- First submitted
- 12 Nov 2019
- Last updated
- 13 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of a Video-based Epilepsy Examination Service
- ClinicalTrials.gov ID
- NCT04171934
- Acronym / sponsor ID
- Nelli / CS001
- Conditions
- Epilepsy; Seizure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Tampere UniversityUniversity, hospital or other
- Collaborators
- Filadelfia Epilepsy Hospital, Aarhus University Hospital, Neuro Event Labs Oy
- Study start
- 17 Jun 2019 (actual)
- Primary completion
- 2 Jul 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 21 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Epileptic motor seizures appearing from rest while patients are in supine position in their monitoring bed.
- The seizures are determined to be epileptic based on electroclinical characteristics by the responsible neurophysiologist / epileptologist.
- The seizures can be classified into motor seizure types (both focal and generalized) using the 2017 International League Against Epilepsy (ILAE) seizure classification.
- The registrations are analyzed by the Nelli system blinded to any clinical information. Nelli system consists of two evaluation components:
- Algorithmic component (pre-trained machine learning model based on video and audio signals)
- Supervisory component (performed by experienced VEEG technicians)
- 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.
- 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:
- To assess the latency from the onset of the seizure detection by the Nelli system in comparison to VEEG registration.
- To determine an inter-rater agreement for the supervisory component of the Nelli system.
- To investigate the performance of the algorithmic component of the Nelli system alone.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adults | – | –Subjects 22+ years of age |
| Pediatric | – | –Subjects less than 22 years of age |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients with epilepsy undergoing a standard VEEG examination for clinical evaluation consenting to participate in the present study
Key exclusion criteria (1 listed)
- Patients not consenting to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
FDR (per hour) and TPR
Time frame: Examination period specific to the patient (1-4 days)
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.
3 secondary outcomes
Latency (seconds)
Time frame: Examination period specific to the patient (1-4 days)
Inter-rater agreement (Cohen's kappa coefficient)
Time frame: Examination period specific to the patient (1-4 days)
Performance of the algorithmic component
Time frame: Examination period specific to the patient (1-4 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy; Seizure, run by Tampere University at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FDR (per hour) and TPR (time frame: Examination period specific to the patient (1-4 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2022.