NCT05635396: ECEME

Seizures Detection in Real Life Setting

Status unknown NA Last updated 2 December 2022

What this trial tests

NA trial testing Wearable, non invasive sensor for seizure detection in Epilepsy; Seizure in 12 participants. Status unknown.

Timeline

15 December 2022

Primary endpoint
15 March 2023

15 March 2023

Quick facts

Lead sponsor	Reliev Technologies
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	12
Start date	15 December 2022
Primary completion	15 March 2023
Estimated completion	15 March 2023

Drugs / interventions tested

• Wearable, non invasive sensor for seizure detection

Conditions studied

• Epilepsy; Seizure — all drugs for Epilepsy; Seizure →
• Focal Epilepsy — all drugs for Focal Epilepsy →

Sponsor

Reliev Technologies

Who can join

7 and older, any sex, with Epilepsy; Seizure or Focal Epilepsy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.