In 2013, Epi-Care free was clinically tested in a study where participants with epilepsy wore the alarm while they were hospitalised for observation. The participants lived in specially designed rooms while wearing EEG measuring equipment and being video-monitored for an average of three days. The data from the EEGs and the video monitoring could then be compared with the results collected from the Epi-Care free alarms. The study showed that Epi-Care free detected nine out of ten seizures. But, will Epi-Care free be as effective when the people with epilepsy move out of the observation room and out into the real world?

That is what Senior Physician Pirgit Meritam and Professors Sándor Beniczky and Philippe Ryvlin have investigated. In 2018, the answer was published in the article “User-based evaluation of applicability and usability of a wearable accelerometer device for detecting bilateral tonic-clonic seizures: A field study”.

Epi-Care technology keeps its promises

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. Hence, the study is based on the users’ personal assessments of Epi-Care free and Epi-Care mobile. The researchers used the questionnaire to verify whether the results gathered in 2013 are still valid when the epilepsy alarm is used in real life.The participants in the 2018 study have all used the epilepsy alarm for an extended period of time. From 24 days to more than six years.

The study shows that Epi-Care free and Epi-Care mobile detects 90 % of all seizures with 0,1 false alarms per day. The results prove that the data from 2013 are still valid. The technology is trustworthy, even in a busy life.

The vast majority of the respondents did either ‘Agree’ or ‘Strongly agree’ that Epi-Care effectively detects seizures.

For a small group of 8 %, the epilepsy alarms are not effective. Thus, there is no guarantee, but for nine out of ten, the Epi-Care technology have kept the users safe from undetected tonic-clonic seizures.

Patients and carers were generally satisfied with Epi-Care mobile, which they consider a comfortable and effective alarm.

It is an alarm that 85 % of the respondents think is easy to learn to use.

Epi-Care gives positive behavioural change

If you have a pulse watch, you are suddenly able to see your pulse in rise and fall in real-time. This may motivate you to train more. Thus, the pulse watch can change your behaviour. Researchers wanted to investigate whether epilepsy alarms also instigate behavioural change. It is not true for everyone, but a majority of the respondents have changed their behaviour due to Epi-Care mobile.

For 55 % of the respondents, their seizures were better recorded and documented. The epilepsy alarms automatically saves the time of the seizures they detect. This is advantageous, as the data can be used to see any connections between behaviour and seizures, e.g. whether lack of sleep, stress or alcohol consumption increases the number of seizures.

For 40 %, the alarm contributed to a reduction in seizure related injuries. This probably happens because relatives or carers can be alerted faster in case of seizures, which can help prevent the person from hitting sharp edges or injuring themself needlessly during the seizures.

Methods

Questionnaires were sent to 112 people, of which, 71 replied. Most were health professionals, carers and relatives, but about a quarter of the respondents were people with epilepsy.

The questionnaire consisted of 10 background questions and 15 questions about the epilepsy alarm itself. The respondents used either Epi-Care free or Epi-Care mobile.

The questions regarding Epi-Care presented the respondents with statements such as: “It is easy to use Epi-Care”. They were asked to answer on a scale from 1 to 7, where 1 was ‘Strongly disagree’ and 7 was ‘Strongly agree’.

The respondents were also able to write their own answers to two questions.

See the original data from the study here.

Epi-Care free and Epi-Care mobile tops the scale

Professor Sándor Beniczky and Assistant Professor Philippe Ryvlin have created a scale for clinical trials of epilepsy alarms. It goes from phase 0 to phase 4.

The clinical trial of Epi-Care free is in phase 3, the scientific field study of Epi-Care free and Epi-Care mobile is in phase 4. These are the only epilepsy alarms investigated in phase 4.

Epi-Care free and Epi-Care mobile have been tested by a total of 117 people. This is the largest clinical trial of an epilepsy alarm that exists.

The researchers behind the study:

Pirgit Meritam - Department of Clinical Neurophysiology, Danish Epilepsy Center, Dianalund, Denmark

Philippe Ryvlin - University Hospital of Lausanne, European Epilepsy Monitoring Association, Lyon, France

Sándor Beniczky - Department of Clinical Neurophysiology, Aarhus University Hospital & Danish Epilepsy Center, Dianalund, Denmark

References:

Beniczky, S., Polster, T., Kjaer, T. W., & Hjalgrim, H. (2013). Detection of generalized tonic–clonic seizures by a wireless wrist accelerometer: A prospective, multicenter study. Epilepsia, 54(4), e58-e61. doi:10.1111/epi.12120

Beniczky, S., & Ryvlin, P. (2018). Standards for testing and clinical validation of seizure detection devices. Epilepsia, 59(S1), 9-13. doi:10.1111/epi.14049

Meritam, P., Ryvlin, P., & Beniczky, S. (2018). User‐based evaluation of applicability and usability of a wearable accelerometer device for detecting bilateral tonic–clonic seizures: A field study. Epilepsia, 59(S1), 48-52. doi:10.1111/epi.14051