Behind the clinical trials

The technology behind the portable Epi-Care alarms is clinically tested.

This means that Danish and German doctors have systematically and scientifically studied the alarm.

The doctors are impartial, and their research and methodology are approved by other doctors and scientists through the scientific process of peer review.

The results are published in the scientific journal Epilepsia. The Journal publishes original articles on all aspects of epilepsy, clinical and experimental.

• In 2013, the first clinical trial "Detection of generalized tonic–clonic seizures by a wireless wrist accelerometer: A prospective, multicenter study" was published.

• In 2018, the second clinical trial “User‐based evaluation of applicability and usability of a wearable accelerometer device for detecting bilateral tonic–clonic seizures: A field study” was published.

Scientific articles are not easy readings. The articles are written using passive wording, as is expected in scientific articles. Moreover, the second article is hidden behind a paywall. To make the content more accessible, we have translated and abridged both articles.

The results from the first clinical trial

73 people participated in the trial. The participants all suspected that they had epilepsy, so they were admitted for ‘Long-term video-EEG monitoring’ at either Filadelfia Epilepsy Hospital, Copenhagen University Hospital or Epilepsie-Zentrum Bethel in Germany.

Throughout the trial, the participants were constantly monitored, and their brains’ electrical signals were measured. On average, each person was monitored for about 3 days. Then, scientists were able to compare the results from the Epi-Care free with the results from the video-EEG trial.

The Epi-Care technology can only measure tonic-clonic seizures. For this reason, participants with other types of epilepsy had to be disqualified from the trial.

Doctors compared the data from the video-EEG with data gathered from the Epi-Care free. These data showed that 20 participants had 39 generalised tonic-clonic epileptic seizures during the trial.

• Epi-Care free discovered 35 out of 39 seizures.

• In two cases, the carers discovered the seizures and held the participant to minimise injuries. This prevented Epi-Care from working properly. These two cases do not count towards the 35 discovered seizures.

• Epi-Care did not detect the last two seizures.

Conclusion

Epi-Care technology discovered nine out of ten tonic-clonic seizures. This was the world’s first clinical trial for a wearable accelerometer-based epilepsy alarm.

The results from the second clinical trial

In the latest trial from 2017, Danish researchers asked people with epilepsy and their carers about their experiences with the alarms.

This makes the Epi-Care series the only one that has been tested using video-EEG monitoring and through long-term everyday use.

The researchers used a questionnaire to ask 71 users of Epi-Care free and Epi-Care mobile about their experiences with the epilepsy alarm.

The questions were answered on a scale from 1 to 7, where 1 was ‘Strongly disagree’ and 7 was ‘Strongly agree’.

The questions were mostly answered by relatives and carers. The trial is built on the users’ personal assessments of Epi-Care free and Epi-Care mobile.

According to this trial, Epi-Care free and Epi-Care mobile discovers nine out of ten seizures. Thus, it confirms the findings of the 2013 trial.

“The large proportion of patients who kept using the device further demonstrated its usability. Patients stopped using the device for reasons related to it in only 10% of cases” the researchers wrote in their scientific article.

For 40 % of the participants who had previously suffered injuries due to seizures, patients and carers agreed that the use of the Epi-Care alarm would have prevented some of the injuries.

Is Epi-Care the best epilepsy alarm?

Many epilepsy alarms have been clinically tested, so how do you know which one is the best?

Unfortunately, it is not a simple question to answer. It is difficult to compare the various trials. Researchers around the world have used many different methods to test epilepsy alarms.

Not before 2017 have there been proposals for a standardisation of clinical trials of epilepsy alarms.

But, there are great arguments for choosing an Epi-Care alarm.

• Epi-Care free and Epi-Care mobile have been tested by a total of 144 people. A far higher number than other epilepsy alarms.

• The Epi-Care series is the only epilepsy alarm that has been tested by both video-EEG monitoring and through long-term everyday use.

• The Epi-Care series was tested by independent researchers with no financial interests in the alarms.

• All Epi-Care alarms are CE marked and fulfil all requirements of the European Medical Device Directive, class I.

Video-EEG is a unique tool for measurement

Long-term video-EEG monitoring

EEG combined with video is used to diagnose the patient’s type of epilepsy.

During video-EEG monitoring, the patient walks around with electrodes on the head while waiting for a seizure to occur. The patient is continuously video monitored. The process can take several days. The participants in the trial waited almost three days on average.

The hospitals try to make the surroundings a little homelier to ease the participants’ time there. The participants were free to move around their room, the living room and the communal kitchen etc. They were also able to watch TV, play video games and the like.

This was a unique setup, as it allowed for precise measurements of brain activity while the participants lived a fairly regular everyday life over several days.

Because there are very few places that perform long-term video-EEG, very few epilepsy alarms have been tested under such precise conditions. So far (2018), just five published scientific articles use long-term video-EEG to test their alarms.