Seizures Detection in Real Life Setting (ECEME)

Reliev Technologies

Status: Not yet enrolling

Conditions: Focal Epilepsy; Epilepsy; Seizure

Treatments: Device: Wearable, non invasive sensor for seizure detection

Study type: Interventional

Funder types: Industry

Identifiers

NCT05635396

2022-A01565-38 (Other Identifier)

ECEME

Details and patient eligibility

About

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).

Enrollment: 12 estimated patients

Sex: All

Ages: 7+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Wearable, non invasive sensor for vital signs recording.

Experimental group

Description:

All included patients will be provided with a wearable, non invasive sensor for vital signs recording.

Treatment:

Device: Wearable, non invasive sensor for seizure detection