Development of a Seizure Detection Algorithm Based on Heart Rate and Movement Analysis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

13 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-05

Study Completion Date

2025-04-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Epilepsy is the 3rd neurological pathology after migraines and dementia syndromes with a high estimate of nearly 600,000 people affected in France. The disease is characterized by the repetition of epileptic seizures on the one hand, but also by the cognitive, behavioral, psychological and social consequences of this condition, especially when the epileptic disease is not stabilized. Epileptic patients feel a great deal of stress due to the unpredictability of the occurrence of seizures.

Seizure detection is of great interest to bioinformatics researchers and to people with epilepsy and their caregivers. Recent advances in physiological sensor technologies and artificial intelligence have opened the possibility of developing systems capable of closely monitoring the frequency of epileptic seizures with a direct impact on therapeutic adaptations. This may eventually allow for seizure prediction and/or "seizure weather" (i.e., seizure forecasting) if there is a particular chronotype of seizure occurrence for a given individual.

Currently, few devices have a sufficient level of evidence regarding their effectiveness to be recommended. Those that seem to be the most advanced are those that allow the identification of hypermotor seizures, including tonic-clonic generalized seizures and tonic-clonic secondary generalized focal seizures, mostly occurring at night. The latter represent only a small part of epileptic seizures.

The objective of the present study is to build a real life database in order to develop a seizure detection algorithm.

The recorded data will be heart rate via ECG and movement data via 9 variables measured on 3 axes x, y, z, with 3 sensors: accelerometer, gyroscope, magnetometer. These data will be collected using a connected patch available on the market (CE marking).

At the same time, the patients will benefit from a long term video-EEG examination which will be annotated by the doctors and will be used as a gold standard for the identification of seizures in order to train the algorithm.

This more complete base will be used to develop an algorithm previously developed from retrospective data.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Epilepsy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

- EEG video recording or extension of an EEG video recording planned as part of the care - Wearing a connected heart rate and motion recording patch

The study consists of creating a database to develop an algorithm using machine learning methods.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Person over 18 years of age - With drug-resistant epilepsy as defined by the International League Against Epilepsy
* Who has at least one recorded seizure with heart rate variation (i.e. tachycardia defined as an increase of 30 bpm or more than 50% over the interictal heart rate and/or bradycardia defined as a heart rate \< 40 bpm or ictal asystole defined as an R-R interval greater than 3 seconds and usually lasting less than 60 seconds)
* Informed about the study and signed a consent to participate in the study (and their legal representative for patients under guardianship)
* Affiliated or beneficiary of a social insurance plan

Exclusion Criteria

* Pregnant or breastfeeding woman
* Persons with psychogenic non-epileptic seizures (PNES)
* Person with a history of severe heart disease (myocardial infarction, heart failure, rhythm disorder, severe hypertension)
* Persons with an implantable cardiac device (pacemaker, implantable defibrillator)
* Documented allergy to hydrogel and/or acrylate
* Person benefiting from a legal protection measure other than guardianship or curatorship

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Institut La Teppe

Tain-l'Hermitage, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PLR_2022_11

Identifier Type: -

Identifier Source: org_study_id