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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.
We describe the longest period of subcutaneous EEG (sqEEG) monitoring to date, in a 35‐year‐old female with refractory epilepsy. Over 230 days, 4791/5520 h of sqEEG were recorded (86%, mean 20.8 [IQR 3.9] hours/day). Using an electronic diary, the patient reported 22 seizures, while automatically‐assisted visual sqEEG review detected 32 seizures. There was substantial agreement between days of reported and recorded seizures (Cohen’s kappa 0.664), although multiple clustered seizures remained undocumented. Circular statistics identified significant sqEEG seizure cycles at circadian (24‐hour) and multidien (5‐day) timescales. Electrographic seizure monitoring and analysis of long‐term seizure cycles are possible with this neurophysiological tool.
Absence seizures are associated with generalized 2.5–5 Hz spike-wave
discharges in the electroencephalogram (EEG). Rarely are patients, parents, or
physicians aware of the duration or incidence of seizures. Six patients were
monitored with a portable EEG-device over four times 24 h to evaluate how easily
outpatients are monitored and how well an automatic seizure detection algorithm
can identify the absences. Based on patient-specific modeling, we achieved a
sensitivity of 98.4% with only 0.23 false detections per hour. This
yields a clinically satisfying performance with a positive predictive value of
87.1%. Portable EEG-recorders identifying paroxystic events in epilepsy
outpatients are a promising tool for patients and physicians dealing with
absence epilepsy. Albeit the small size of the EEG-device, some children still
complained about the obtrusive nature of the device. We aim at developing less
obtrusive though still very efficient devices, e.g., hidden in the ear canal or
below the skin.
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