MJN-SERAS

Improving quality of life for people with epilepsy

The challenge

According to World Health Organisation, around 50 million people currently live with epilepsy worldwide, with an estimated 5 million new cases diagnosed each year.[1] Epilepsy affects between 1.5 and 2% of the total world population.[2] Approximately 30% of people affected with epilepsy are drug-resistant.[3]

Epilepsy is a chronic disorder of the brain that affects people of all ages. People affected by uncontrolled epilepsy suffer from unpredictable seizures: they do not know when they could have a seizure, or if it could cause a serious accident.

Living with epilepsy has a significant impact on those with the condition and their caregivers. The risk of premature death in people with epilepsy is up to three times higher than for the general population.[4] The unpredictability of seizures can prevent people with epilepsy from doing normal activities and may lead to depression. Seizure risk can also require those affected to be close to caregivers, which has an associated cost. Parents of children with epilepsy often cannot continue their professional career.

Currently, the only way of properly monitor epilepsy-affected people is by continuous brain signal recording, through an electroencephalography (EEG). However, this practice requires hospitalisation. The data obtained in hospital is temporary and does not demonstrate patients’ daily reality.

There are a very limited number of commercial devices to record epilepsy seizures on the market and none of them record brain signals. One solution works by recording patients’ wrist or ankle movement when convulsions start. However, the recording sensitivity rate is extremely low and offers a high number of false positives.[5] This, together with the fact that it alerts when the seizure starts (not before), does not guarantee the safety of epilepsy-affected people.

The main failures current commercial solutions are that they cannot predict a seizure but only detect it. They have a very low reliability as they do not record brain signals, which are the most direct evidence of seizure.

The solution

The MJN-SERAS project team are working to overcome the challenge of predicting epileptic seizures through new technology which aims to improve the lives of those affected by epilepsy. Their solution is a wearable, discreet, non-invasive, medical device designed to predict epileptic seizures with high reliability.

MJN-SERAS is an earpiece, shaped as a hearing aid device, which continuously records the electrical brain activity like a medical EEG, by means of an electronic component. Thanks to the team’s proprietary artificial intelligence algorithm, their device can determine if a seizure will suddenly happen.

Drug-resistant epilepsy-affected people can comfortably wear MJN-SERAS on a daily basis. Between 1 to 3 minutes before seizures, an alarm warns patients via their mobile phone which is connected via Bluetooth to the earpiece. Within this time patients can autonomously reach a safe place or position to avoid accidents and injuries, helping them become independent from caregivers.

Expected impact

The objective of this project is to broaden the potential of this solution to improve the quality of life of epilepsy-affected people across Europe and their caregivers.

By helping to predict seizures, MJN-SERAS will help those with drug-resistant epilepsy to become more independent, reduce their risk of injury, and increase their freedom to enjoy daily life. The data the device records will help neurologists to improve the monitorisation and treatment of the illness. In this way, the project promises to improve epilepsy care pathways.

The next step for the team is to get the MJN-SERAS solution (both the device and algorithm) validated by a clinical study carried out with 150 patients in Spain, Germany and UK. The improved technology will be compliant with the Medical Device Regulation and the team are also exploring reimbursement pathways in Europe for the device.

External Partners

• MJN Neuroserveis
• Goethe University Frankfurt
• Projectes Galgot SL

References

[1] World Health Organisation. (2022). Epilepsy. [online] Available at: <https://www.who.int/en/news-room/fact-sheets/detail/epilepsy> [Accessed 24 March 2022].  

[2] World Health Organisation. (2022). Epilepsy. [online] Available at: <http://www.who.int/mediacentre/factsheets/fs999/en/> [Accessed 24 March 2022].

[3] Alexopoulos, A.V. (2013). Pharmacoresistant epilepsy: Definition and explanation. Epileptology, 1(1), pp.38–42.

[4] World Health Organisation. (2022). Epilepsy. [online] Available at: <https://www.who.int/en/news-room/fact-sheets/detail/epilepsy> [Accessed 24 March 2022]. 

[5] Onorati, F., et al. (2021). Prospective Study of a Multimodal Convulsive Seizure Detection Wearable System on Pediatric and Adult Patients in the Epilepsy Monitoring Unit. Frontiers in Neurology. [online] Available at: <https://www.frontiersin.org/articles/10.3389/fneur.2021.724904/full> [Accessed 24 March 2022].