A crucial, deeper understanding of the number of seizures has come a step closer. This is revealed in a Danish study from Zealand University Hospital, just published in the recognised, peer-reviewed Epilepsia. The study indicates that patients’ diary-based self-reporting of seizures leads to both over- and under-reporting. Both are serious, because the treating neurologist has no basis on which to choose the optimal treatment in an attempt to stop the seizures, having had little insight into the patient's everyday life.
Epilepsy is a chronic disease of the brain characterized by recurrent epileptic seizures. Therefore, seizure counting is essential in tracking disease activity and a decisive factor in choice of treatment. Traditionally, patients undertake diary-based seizure self-reporting but the method is often unreliable and can lead to the wrong treatment.
The study aimed to explore the feasibility of objective long-term monitoring of epilepsy patients using the UNEEG 24/7, a new subcutaneous EEG device. Nine patients were included in the study, which collected EEG data over 490 days. No serious device-related adverse events were reported, and no patients felt that their everyday work or leisure activities were disrupted.
Advanced implantable technology
A recently developed technology uses a small implant behind the ear to collect the brain’s electrical waves (EEG) and uses advanced algorithms to translate the waves into a count of a person’s seizures, both day and night. The technology has been more than 10 years in the making and is now both CE-approved and scientifically substantiated. The UNEEG 24/7 system from the Danish company UNEEG medical consists of three components: a small implant the size of a 1p coin, surgically inserted just below the skin behind the ear; a mobile EEG recorder that continuously logs the brain’s electrical waves (EEG); and some complex software.
Research is the first seal of approval for objective long-term home monitoring
Troels W. Kjær, Chief Physician at the Department of Zealand University Hospital’s Department of Neurology and professor at the University of Copenhagen, is behind the study. ‘Unfortunately, typical methods give no objective understanding of epileptic seizures, and the study has shown that there are significant differences between participants’ self-reporting and the objective electrographic measurements.’
An example of this is shown through one participant in the study who recorded 34 seizures in her diary – but the new technology revealed that this person actually had as many as 232 seizures in the same period.
Zealand University Hospital has just purchased and implanted the first UNEEG 24/7 system in the expectation that this will allow them to offer improved treatment to patients.
‘A lack of objective knowledge can mean that the medication is not optimally dosed, and the seizures therefore cannot be kept in check. This can lead to impaired memory and an ongoing deterioration of cognitive functions as a result of repeated seizures. And, in the worst case, the seizures can have a fatal outcome’, Professor Troels W. Kjær concludes.
International attention from epilepsy centres
In addition to the scientific work at Zealand University Hospital, the technology is attracting international interest. In collaboration with King’s College London, one of the world’s leading epilepsy research centres, the U.S. patient association, the Epilepsy Foundation, has initiated further clinical research. The centre has already purchased a number of devices, two of which have already been implanted.
Formal collaboration is being established with more epilepsy centres in Europe, as these centres also consider that the technology will be of value to their patients.
Globally, about 1% of the world’s population, or 50 million people, are estimated to have epilepsy – and more than 500,000 in UK alone. ‘In the first instance, we hope to be able to help the 30% or so of patients who cannot be made seizure-free with the technology and knowledge available until now’, says Torben Sandgren, the CEO of UNEEG medical. ‘The task now is to persuade the health authorities to accept this technology and to cover patients’ costs, something that will be done in close collaboration with the leading epilepsy centres in Europe and the USA.’
To date, the implant has been approved for adults, but UNEEG medical is also working to obtain approval for children. The primary target group for the technology is patients with temporal lobe epilepsy or generalised epilepsy where suboptimal treatment is suspected.
The full study, ‘Ultra-long-term subcutaneous home monitoring of epilepsy – 490 days of EEG from nine patients’, may be found here
Download study as pdf >
- Torben Sandgren, CEO, UNEEG medical A/S, M: 2260 1734, Email: firstname.lastname@example.org
- Professor Troels Wesenberg Kjær MD, PhD, Consultant, Department of Neurology, Zealand University Hospital, Roskilde, Tel. +45 2332 7278
Danish Press Release >