FutureNeuro, the SFI Research centre for chronic and rare neurological disease, will partner with Danish company UNEEG Medical, to trial a subcutaneous implantable monitoring device to record epileptic seizures. The study is led by Prof Norman Delanty, clinical neurologist and epilepsy lead in Beaumont Hospital and investigator with FutureNeuro.

Epilepsy is one of the most common chronic brain diseases, affecting over 65 million people worldwide. 1 in 115 people in Ireland have epilepsy. For people living with epilepsy, undetected seizures pose many challenges. They can lead to an increased risk of seizures left untreated or overtreatment with antiepileptic drugs. Epilepsy is characterized by unpredictable seizures. There are many different types of epileptic seizures, many of which are subtle and can hardly be noticed, while others are disabling.

Currently, seizures histories are captured based on patient, family member or carer seizure reporting or clinical examination. The most effective way to detect seizures is in an Epilepsy Monitoring Unit (EMU) in neurology treatment centres, such as Beaumont Hospital, using specialist video electroencephalogram (EEG) equipment. However, in-patient monitoring can create many barriers for patients and their families, particularly those with intellectual disability, as they are removed from their home environment for an average 7-day stay in the centre.  Moreover, there is limited availability of beds in monitoring units such as Beaumont, which due to the restrictions of the global Covid-19 pandemic, is currently temporarily closed.

This initial pilot study will focus on two cohorts of patients, one with poorly controlled idiopathic generalised epilepsy, and the other with difficult to control symptomatic generalised epilepsy (usually associated with a degree of intellectual disability).

The implantable device, which is about the size of a €1 coin, is inserted, using local anaesthetic, behind the patient’s ear. They return home, and for 2 weeks, their seizures are recorded while they are sleeping, walking about, or continuing activities of daily living. Patients will then spend 2-3 days in Beaumont EMU where their seizures are measured using EEG and video. This study aims to determine how well the implantable device compares to the gold standard in-patient monitoring.

 

Norman Delanty

28 August 2019: Professor Norman Delanty, Consultant Neurologist, RCSI/Beaumont Hospital. Pictured at the Royal College of Surgeons Education & Research Centre, Beaumont Hospital, Dublin. Pic credit: Ray Lohan/RCSI

According to Professor Norman Delanty, ‘The fundamental issue when recording seizures is that often records may not be accurate. This study will help us determine if the UNEEG Medical device can be used as a supplement or possible alternative to existing in-patient monitoring technology. If effective, it could lead to better diagnosis and treatment outcomes.’

Adding to the pilot study announcement, Torben Sandgren CEO of UNEEG Medical commented, ‘We are very pleased to partner with FutureNeuro and leading neurology researchers in Ireland, to evaluate how our 24/7 EEG SubQ device could be used to obtain an objective, accurate and reliable understanding of seizure events for this patient cohort.’

FutureNeuro Director Prof David Henshall added ‘The mission of FutureNeuro is to support people with neurological disease to live independently. I am pleased that we are involved in clinical-led research which could improve seizure tracking and ultimately promote better seizure management.’