| Literature DB >> 33025543 |
Baharan Kamousi1, Suganya Karunakaran1, Kapil Gururangan2, Matthew Markert3, Barbara Decker4, Pouya Khankhanian4, Laura Mainardi4, James Quinn5, Raymond Woo1, Josef Parvizi6.
Abstract
INTRODUCTION: Current electroencephalography (EEG) practice relies on interpretation by expert neurologists, which introduces diagnostic and therapeutic delays that can impact patients' clinical outcomes. As EEG practice expands, these experts are becoming increasingly limited resources. A highly sensitive and specific automated seizure detection system would streamline practice and expedite appropriate management for patients with possible nonconvulsive seizures. We aimed to test the performance of a recently FDA-cleared machine learning method (Claritγ, Ceribell Inc.) that measures the burden of seizure activity in real time and generates bedside alerts for possible status epilepticus (SE).Entities:
Keywords: Electroencephalography; Machine learning method; Neurology; Seizure burden; Status epilepticus
Year: 2020 PMID: 33025543 PMCID: PMC8021593 DOI: 10.1007/s12028-020-01120-0
Source DB: PubMed Journal: Neurocrit Care ISSN: 1541-6933 Impact factor: 3.210
Fig. 1Rapid Response EEG system. The Rapid Response EEG system (Rapid-EEG) consists of a portable EEG recorder and a disposable electrode headband. Recorded EEG tracings are shown on the device screen (1) and sonified when needed (2) by the bedside recorder. HIPAA-compliant secure Wi-Fi connection enables real-time transfer of the data to the cloud where the EEG tracings can be reviewed by expert neurologists using the remote portal for EEG review (3). Machine learning computations (by Claritγ algorithm) are performed on the cloud portal (4) interfacing in real time with the bedside device. As such, the system is meant to provide not only easy and fast access to EEG acquisition, but also a reliable and actionable diagnostic information for risk stratification using four different modes of triage
Fig. 2Computation of seizure burden. The output of the Claritγ algorithm was a continuous quantitative trend of seizure burden values, which represented the percentage of 10-second long bins of EEG data in a 5-min period that contained seizure activity. Seizure burden values updated every 10 s; therefore, consecutive seizure burden values (e.g., value 1 and 2, as shown, offset by 10 s) could represent the evolution of the patient’s seizure prevalence over the course of the recording. Seizure burden thresholds were adapted from American Clinical Neurophysiology Society guidelines [22], such that “frequent” seizure activity was defined as 10% seizure burden (i.e., 30 s of seizure activity within a 5-min period), “abundant” seizure activity was defined as 50% seizure burden (i.e., 2.5 min of seizure activity within a 5-min period), and “continuous” seizure activity was defined as 90% seizure burden (i.e., 4.5 min of seizure activity within a 5-min period). An alert was presented to the user when seizure burden reached a threshold of 90%, which indicated a high risk of status epilepticus and the impending need for urgent clinical intervention
Fig. 3Samples of EEG recorded with Ceribell Rapid Response EEG System. Each EEG is displayed in a ten-second epoch with filter settings of 1–30 Hz. The line plot under each EEG shows the Claritγ algorithm output. The top image shows seizure activity approaching the 90% threshold to trigger a status epilepticus alert, and the bottom image shows lateralized periodic discharges that go undetected by the algorithm
Summary of Claritγ Performance (individual patient level)
| Claritγ output, % seizure burden | Human expert rating, n | ||||
|---|---|---|---|---|---|
| SE | SZ | HEP | NL/SL | Total | |
| SZ burden ≥ 90% | 9 | 0 | 21 | 3 | 33 |
| SZ burden 50–89% | 0 | 3 | 21 | 15 | 39 |
| SZ burden 10–49% | 0 | 3 | 20 | 56 | 79 |
| SZ burden 1–9% | 0 | 0 | 5 | 18 | 23 |
| SZ burden 0% | 0 | 2 | 20 | 157 | 179 |
| Total | 9 | 8 | 87 | 249 | 353 |
HEP highly epileptiform pattern, NL normal background activity, SE status epilepticus, SL slow background activity, SZ seizure
Sensitivity and specificity of Claritγ algorithm for seizure detection
| Claritγ output | Patient level | Event level | |||||
|---|---|---|---|---|---|---|---|
| Sensitivity (95% CI) | Specificity (95% CI) | Sensitivity (95% CI) | False positives (95% CI) | FDRa | |||
| SZ burden ≥ 90% | 9 | 100.0%c | 93.0% | 13 | 92.3%b | 62 | 0.06 |
| 95% CI | [90, 95] | [60, 100] | |||||
| SZ burden ≥ 50% | 12 | 100.0%c | 82.4% | 18 | 100.0%c | 139 | 0.13 |
| 95% CI | [78, 87] | ||||||
| SZ burden ≥ 10% | 17 | 88.2% | 59.5% | 35 | 80.0% | 324 | 0.31 |
| 95% CI | [65, 100] | [54, 65] | [63, 91] | ||||
CI confidence interval, FDR false detection rate
aFalse detection rate (in events per hour of EEG) was calculated as the number of false positive events divided by the duration of recording (in hours)
bOne seizure event that did not trigger a status alarm occurred during the last 10 min of a 200-min EEG record. The algorithm correctly identified the seizure, but the threshold for 90% seizure burden (4.5 min) was not yet reached at the time the recording was discontinued
cConfidence intervals are not calculated in cases where the sampled sensitivity was 100% as estimated confidence intervals in the event of perfect sample sensitivity do not provide meaningful information
Variability in status epilepticus detection between individual experts and Claritγ status alert compared to expert consensus
| Reviewer | Sessions reviewed | Sensitivity (%) | Specificity (%) |
|---|---|---|---|
| 1 | 240 | 62.5 | 94.8 |
| 2 | 198 | 20.0 | 99.5 |
| 3 | 257 | 88.9 | 94.3 |
| 4 | 89 | 66.7 | 95.2 |
| Claritγ | 353 | 100.0 | 93.0 |
Fig. 4Summary of Claritγ Performance. Performance of Claritγ algorithm at the group level suggests that the algorithm can be seen as a reliable triage tool to help detect cases of status epilepticus with the highest sensitivity (while overcalling about one-fourth of highly epileptiform patterns as possible status epilepticus). It also performs as a reliable triage tool to help physicians avoid over-aggressive treatments in majority of EEG cases where the overwhelming pattern is either slowing or normal. HEP highly epileptiform patterns, NL normal activity, RDA rhythmic delta activity, SE status epilepticus, SL slow activity, SZ seizure
Suggested clinical implementation workflow of Claritγ algorithm
| Pretest clinical suspicion | |||
|---|---|---|---|
| High | Low | ||
| AI output | > 90% | Treat urgently → urgent review of EEGa | Review of EEG → treat if seizures confirmed on EEG or if EEG reading is not readily possible |
| 10–90% | Review of EEG → treat if seizures confirmed on EEG or if EEG reading is not readily possible | Do not treat yet → Review of EEG whenever possible | |
| < 10% | Do not treat yet→ Review of EEG whenever possible | Do not treat → nonurgent review of EEG | |
aExpedited review of EEG can be done remotely in real time by a neurologist with EEG expertise since the Rapid-EEG device sends the EEG data wirelessly to a cloud portal. EEG review can also be performed at the bedside by both expert or nonexpert users. For instance, similar to common models of electrocardiographic monitoring [40] or bedside quantitative EEG products [41, 42], critical care staff may be trained to recognize the most salient and clinically important EEG signatures associated with status epilepticus. They can rely on their own bedside visual EEG review combined with the Rapid-EEG’s Brain Stethoscope function [43]. In three clinical studies so far, staff with minimal or no EEG experience increased their accuracy of seizure diagnosis significantly by relying on either Brain Stethoscope alone [15, 16] or combined with bedside visual EEG review [17]. It is important to note that a much larger number of EEG cases often do not result in seizure output, and hence, use of the algorithm will lead to prevention of overtreatment of these cases. Given the high sensitivity of the algorithm, false negative cases would be much less frequent