Clinical trial NCT05635396: Seizures Detection in Real Life Setting
Official title: A Prospective, Multicenter, Exploratory Study for Epileptic Seizures Detection Through Multimodal Analysis of Cardiorespiratory and Actimetry Parameters
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Epilepsy; Seizure
Focal Epilepsy
Lead sponsor: Reliev Technologies
Sponsor class: INDUSTRY
First posted: 2022-12-02
Enrollment: 12
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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).


Eligibility criteria: 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

Primary outcomes:
measure: Number of true positive seizures.
timeFrame: From baseline up to 4 weeks.
measure: Number of false positive seizures.
timeFrame: From baseline up to 4 weeks.
measure: Number of false negative seizures.
timeFrame: From baseline up to 4 weeks.
Secondary outcomes:
measure: Changes in Number of true positive, true negative and false negative seizures throughout the study duration.
timeFrame: From baseline up to 4 weeks.
measure: Changes in number of true positive, true negative and false negative seizures depending on patients' characteristics.
timeFrame: From baseline up to 4 weeks.
measure: Sensor tolerability from patients' perspective.
timeFrame: At 4 weeks after baseline.
measure: Sensor tolerability from care givers' perspective.
timeFrame: At 4 weeks after baseline.
measure: Electrocardiogram signal quality in real life setting.
timeFrame: From baseline up to 4 weeks.
measure: ECG data impact (ECG characteristics) on seizures detection.
timeFrame: From baseline up to 4 weeks.
measure: Heart rate impact on seizures detection.
timeFrame: From baseline up to 4 weeks.
measure: Respiration rate impact on seizures detection.
timeFrame: From baseline up to 4 weeks.
measure: Body orientation impact on seizures detection.
timeFrame: From baseline up to 4 weeks.
measure: Activity impact on seizures detection.
timeFrame: From baseline up to 4 weeks.
Other outcomes:
Locations:
Study officials:
affiliation: CHU Rennes
name: Silvia NAPURI, MD
role: PRINCIPAL_INVESTIGATOR
References: