Standards for testing and clinical validation of seizure detection devices

Beniczky, Sándor; Ryvlin, Philippe

doi:10.1111/epi.14049

Cited by 115 publications

(133 citation statements)

References 21 publications

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“…Several studies have shown that intracranial electrodes, if positioned correctly in relation to the seizure focus, can be used to detect more seizures than scalp EEG electrodes. 34 Such standards should guide future studies on novel seizure-detection devices to facilitate comparison between studies and meta-analyses. 33 Another way to get around this problem is to perform large-scale trials comparing clinical outcomes for groups of patients in whom decision-making was based on traditional methods to other groups in whom decision-making was informed by whatever method in question.…”

Section: Limitationsmentioning

confidence: 99%

Ultra‐long‐term subcutaneous home monitoring of epilepsy—490 days of EEG from nine patients

et al. 2019

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ObjectiveTo explore the feasibility of home monitoring of epilepsy patients with a novel subcutaneous electroencephalography (EEG) device, including clinical implications, safety, and compliance via the first real‐life test.MethodsWe implanted a beta‐version of the 24/7 EEG SubQ (UNEEG Medical A/S, Denmark) subcutaneously in nine participants with temporal lobe epilepsy. Data on seizures, adverse events, compliance in using the device, and use of antiepileptic drugs (AEDs) were collected. EEG was recorded for up to 3 months, and all EEG data were reviewed visually to identify electrographic seizures. These were descriptively compared to seizure counts and AED changes reported in diaries from the same period.ResultsFour hundred ninety days of EEG and 338 electrographic seizures were collected. Eight participants completed at least 9 weeks of home monitoring, while one cancelled participation after 4 weeks due to postimplantation soreness. In total, 13 cases of device‐related adverse events were registered, none of them serious. Recordings obtained from the device covered 73% of the time, on average (range 45%‐91%). Descriptively, electrographic seizure counts were substantially different from diary seizure counts. We uncovered several cases of underreporting and revealed important information on AED response. Electrographic seizure counts revealed circadian distributions of seizures not visible from seizure diaries.SignificanceThe study shows that home monitoring for up to 3 months with a subcutaneous EEG device is feasible and well tolerated. No serious adverse device‐related events were reported. An objective seizure count can be derived, which often differs substantially from self‐reported seizure counts. Larger clinical trials quantifying the benefits of objective seizure counting should be a priority for future research as well as development of algorithms for automated review of data.

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Section: Limitationsmentioning

confidence: 99%

Ultra‐long‐term subcutaneous home monitoring of epilepsy—490 days of EEG from nine patients

et al. 2019

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“…There is a well‐documented need for wearable seizure detection devices and a marked increase in the number of papers reporting such attempts . However, more validation studies are needed to provide proof of utility and accuracy of these tools . Only very few multicenter, prospective, blinded phase 3 studies have provided compelling evidence of effective real‐time seizure detection .…”

Section: Introductionmentioning

confidence: 99%

“…However, more validation studies are needed to provide proof of utility and accuracy of these tools . Only very few multicenter, prospective, blinded phase 3 studies have provided compelling evidence of effective real‐time seizure detection . These studies are typically conducted in epilepsy monitoring units (EMUs), which differ from the natural home environment, in particular regarding patients’ mobility .…”

Section: Introductionmentioning

confidence: 99%

“…These studies are typically conducted in epilepsy monitoring units (EMUs), which differ from the natural home environment, in particular regarding patients’ mobility . Thus, it has been proposed that phase 3 validation studies are followed by field studies (phase 4) in the patients′ home environment, addressing issues of applicability and usability from patients’ and caregivers’ perspective …”

Section: Introductionmentioning

confidence: 99%

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User‐based evaluation of applicability and usability of a wearable accelerometer device for detecting bilateral tonic–clonic seizures: A field study

Meritam¹,

Ryvlin

Beniczky

2018

Epilepsia

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Clinical validation studies of seizure detection devices conducted in epilepsy monitoring units (EMUs) can be biased by the artificial environment. We report a field (phase 4) study of a wearable accelerometer device (Epi-Care) that has previously been validated in EMUs for detecting bilateral tonic-clonic seizures (BTCS). Seventy-one patients using the device (or their caregivers) completed the modified Post-Study System Usability Questionnaire. Median time patients had been using the device was 15 months (range = 24 days-6 years). In 10% of cases, patients stopped using the device due to reasons related to the device. The median sensitivity (90%) and false alarm rate (0.1/d) were similar to what had been determined in EMUs. Patients and caregivers were overall satisfied with the device (median = 5.5 on the 7-point Likert scale), considered the technical aspects satisfactory, and considered the device comfortable and efficient. Adverse effects occurred in 11%, but were only mild: skin irritation at the wrist and interference with home electronic appliances. In 55% the device influenced the number of seizures logged into the seizure diary, and in 40% it contributed to fewer seizure-related injuries. This field study demonstrates the applicability and usability of the wearable accelerometer device for detecting BTCS.

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“…Another phase‐2 study that retrospectively analyzed EMG signals recorded with conventional amplifiers in EMU, reported a different approach . The algorithm used Hotelling's T‐squared power analysis of compound muscle action potentials, and it was patient‐tailored: MVC was initially measured in each patient to establish the baseline (physiologic) threshold .…”

Section: Emg‐based Automated Detection Of Convulsive Seizuresmentioning

confidence: 99%

Detection of convulsive seizures using surface electromyography

2018

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Bilateral (generalized) tonic-clonic seizures (TCS) increase the risk of sudden unexpected death in epilepsy (SUDEP), especially when patients are unattended. In sleep, TCS often remain unnoticed, which can result in suboptimal treatment decisions. There is a need for automated detection of these major epileptic seizures, using wearable devices. Quantitative surface electromyography (EMG) changes are specific for TCS and characterized by a dynamic evolution of low- and high-frequency signal components. Algorithms targeting increase in high-frequency EMG signals constitute biomarkers of TCS; they can be used both for seizure detection and for differentiating TCS from convulsive nonepileptic seizures. Two large-scale, blinded, prospective studies demonstrated the accuracy of wearable EMG devices for detecting TCS with high sensitivity (76%-100%). The rate of false alarms (0.7-2.5/24 h) needs further improvement. This article summarizes the pathophysiology of muscle activation during convulsive seizures and reviews the published evidence on the accuracy of EMG-based seizure detection.

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Standards for testing and clinical validation of seizure detection devices

Cited by 115 publications

References 21 publications

Ultra‐long‐term subcutaneous home monitoring of epilepsy—490 days of EEG from nine patients

Ultra‐long‐term subcutaneous home monitoring of epilepsy—490 days of EEG from nine patients

User‐based evaluation of applicability and usability of a wearable accelerometer device for detecting bilateral tonic–clonic seizures: A field study

Detection of convulsive seizures using surface electromyography

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