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

Epilepsy Clinical Trial

— DetecTeppe  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05637762
• Other study ID #: PLR_2022_11
• Status: Recruiting
• Start date: June 5, 2023
• Est. completion date: February 2025

Study information

• Verified date: July 2023
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: Amelie Yavchitz, MD
• Phone: +331 48 03 64 54
• Email: ayavchitz[@]for.paris
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy
• Seizures

Intervention

Other:
• - 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.

Locations

Country	Name	City	State
France	Institut La Teppe	Tain-l'Hermitage

Sponsors (2)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild	La Teppe Institute

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To build a training database under physiological conditions allowing the development of a detection algorithm for generalized and focal epileptic seizures in adults with epilepsy.	Movements will be measured with accelerometer.	Day12