Seizures Detection in Real Life Setting

Focal Epilepsy Clinical Trial

— ECEME  

Official title:

A Prospective, Multicenter, Exploratory Study for Epileptic Seizures Detection Through Multimodal Analysis of Cardiorespiratory and Actimetry Parameters

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05635396
• Other study ID #: ECEME
• Secondary ID: 2022-A01565-38
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 15, 2022
• Est. completion date: March 15, 2023

Study information

• Verified date: November 2022
• Source: Reliev Technologies
• Contact: Laurent RIBIERE
• Phone: (0)6 52 27 52 02
• Email: l.ribiere[@]reliev.io
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Epilepsy is a disabling neurological disease that affects tens of millions of people worldwide. Despite therapeutic advances, about a third of these patients suffer from treatment-resistant forms of epilepsy and still experience regular seizures.All seizures can last and lead to status epilepticus, which is a major neurological emergency. Epilepsy can also be accompanied with cognitive or psychiatric comorbidities.

Reliable seizures count is an essential indicator for estimating the care quality and for optimizing treatment. Several studies have highlighted the difficulty for patients to keep a reliable seizure diary due for example to memory loss or perception alterations during crisis. Whatever the reasons, it has been observed that at least 50% of seizures are on average missed by patients.

Seizure detection has been widely developed in recent decades and are generally based on physiological signs monitoring associated with biomarkers search and coupled with detection algorithms. Multimodal approaches, i.e. combining several sensors at the same time, are considered the most promising.

Mobile or wearable non invasive devices, allowing an objective seizures documentation in daily life activities, appear to be of major interest for patients and care givers, in detecting and anticipating seizures occurence.

This single-arm exploratory, multicenter study aims at assessing whether the use of such a non-invasive, wearable device can be useful in a real life setting in detecting seizures occurence through multimodal analysis of various parameters (heart rate, respiratory and accelerometry).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: March 15, 2023
• Est. primary completion date: March 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years and older

Eligibility

Inclusion Criteria:

• Patients aged 7 years old or more

• Patients with drug-resistant focal epilepsy

• Patients with high frequency seizures according to investigator's judgement

• Patients that can be followed 4 weeks after inclusion

• Informed consent form signed.

Exclusion Criteria:

• Generalised tonic-clonic seizures

• Frequent psychogenic non-epileptic seizures

• Pregnant or breastfeeding patients

• Patients displaying sensor contraindications

Related Conditions & MeSH terms

• Epilepsies, Partial
• Epilepsy
• Epilepsy; Seizure
• Focal Epilepsy
• Seizures

Intervention

Device:
• Wearable, non invasive sensor for seizure detection
The device consists of a chest strap and an electronics module that attaches to the strap. The device stores and transmits vital sign data including ECG, heart rate, respiration rate, body orientation and activity. This sensor will be worn every day (on a 24 hours basis) excepted during weekends for up to 4 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Reliev Technologies

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of true positive seizures.	The number of true positive seizures will be measured, ie. seizures detected through the sensor and reported in a seizures diary completed in real time by care giver.	From baseline up to 4 weeks.
Primary	Number of false positive seizures.	The number of false positive seizures will be measured, ie. seizures detected through the sensor but not reported in the seizures diary completed in real time by care giver.	From baseline up to 4 weeks.
Primary	Number of false negative seizures.	The number of false negative seizures will be measured, ie. seizures not detected through the sensor but reported in the seizures diary completed in real time by care giver.	From baseline up to 4 weeks.
Secondary	Changes in Number of true positive, true negative and false negative seizures throughout the study duration.	Data from sensor will be analysed and compared to seizures diary.	From baseline up to 4 weeks.
Secondary	Changes in number of true positive, true negative and false negative seizures depending on patients' characteristics.	Number of true positive, true negative and false negative seizures will be analysed and compared between patients based on patients' clinical characteristics.	From baseline up to 4 weeks.
Secondary	Sensor tolerability from patients' perspective.	The French Version of the System Usability Scale (F-SUS) will be used. It is a self-questionnaire including 10 questions, ranging from 0 "I do not agree at all" up to 10 "I completely agree".	At 4 weeks after baseline.
Secondary	Sensor tolerability from care givers' perspective.	A self-questionnaire including 5 questions will be used, ranging from 0 "I do not agree at all" up to 10 "I completely agree".	At 4 weeks after baseline.
Secondary	Electrocardiogram signal quality in real life setting.	Electrocardiogram signal quality will be compared between data obtained from sensor (real life setting) and data obtained from video-EEG monitoring (hospital setting).	From baseline up to 4 weeks.
Secondary	ECG data impact (ECG characteristics) on seizures detection.	Contribution from ECG data will be analysed as stand-alone parameter and as associated parameter in multimodal monitoring.	From baseline up to 4 weeks.
Secondary	Heart rate impact on seizures detection.	Contribution of data from heart rate will be analysed as stand-alone parameter and as associated parameter in multimodal monitoring.	From baseline up to 4 weeks.
Secondary	Respiration rate impact on seizures detection.	Contribution of data from respiration rate will be analysed as stand-alone parameter and as associated parameter in multimodal monitoring.	From baseline up to 4 weeks.
Secondary	Body orientation impact on seizures detection.	Contribution from body orientation data will be analysed as stand-alone parameter and as associated parameter in multimodal monitoring.	From baseline up to 4 weeks.
Secondary	Activity impact on seizures detection.	Contribution of activity data will be analysed as stand-alone parameter and as associated parameter in multimodal monitoring.	From baseline up to 4 weeks.