Seizures Detection in Real Life Setting

NCT05635396 | Unknown

• 2 other identifiers: ECEME2022-A01565-38
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Epilepsy; Seizure; Focal Epilepsy

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• 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 Outcomes (10)

• Changes in Number of true positive, true negative and false negative seizures throughout the study duration.

  From baseline up to 4 weeks.

• Changes in number of true positive, true negative and false negative seizures depending on patients' characteristics.

  From baseline up to 4 weeks.

• Sensor tolerability from patients' perspective.

  At 4 weeks after baseline.

• Sensor tolerability from care givers' perspective.

  At 4 weeks after baseline.

• Electrocardiogram signal quality in real life setting.

  From baseline up to 4 weeks.

Study Arms (1)

Wearable, non invasive sensor for vital signs recording.

EXPERIMENTAL

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

Device: Wearable, non invasive sensor for seizure detection

Interventions

Wearable, non invasive sensor for seizure detection DEVICE

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.

Wearable, non invasive sensor for vital signs recording.

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 7 years old or more
• Patients with drug-resistant focal epilepsy
• Patients with high frequency seizures according to investigator's judgement
• Informed consent form signed.

You may not qualify if:

• Generalised tonic-clonic seizures
• Frequent psychogenic non-epileptic seizures
• Pregnant or breastfeeding patients
• Patients displaying sensor contraindications

Sponsors & Collaborators

• Reliev Technologies: lead

MeSH Terms

Conditions

Epilepsy; Epilepsies, Partial

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Silvia NAPURI, MD

  CHU Rennes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurent RIBIERE

CONTACT

(0)6 52 27 52 02; l.ribiere@reliev.io

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: December 2, 2022
• Study Start: December 15, 2022
• Primary Completion: March 15, 2023
• Study Completion: March 15, 2023
• Last Updated: December 2, 2022

Record last verified: 2022-11