Ceribell Point-of-Care EEG Platform Outperforms Conventional EEG Across Various Outcomes in Mutlicenter Study

Masoom J. Desai, MD, FACNS

In a recently published multicenter, retrospective study, early use of Ceribell’s point-of-care electroencephalography (POC-EEG) system led to greater detection nonconvulsive seizures and decreased intensive care unit (ICU) length of stay (LOS) than conventional EEG. In addition, the POC-EEG system differed from conventional EEG on functional outcomes and further emphasized the benefit of early diagnosis of nonconvulsive seizures.^1,2

Published in Neurocritical Care, investigators performed a retrospective subanalysis of the recently completed SAFER-EEG trial that included 283 ICU patients, 221 who received Ceribell’s system and 62 on conventional EEG. Between the 2 groups, those who received POC-EEG had an average 3.9 (IQR, 1.9-8.8) days in ICU vs 8.0 (IQR, 3.0-16.0) for conventional EEG (P = .003). In addition, the study revealed an 18% difference in modified Rankin scale functional outcomes between the 2 EEG cohorts (P = .047), favoring POC-EEG.

"Ceribell use is associated with shorter stays in the ICU and better functional outcomes, which are extremely impactful benefits to patients and their families," principal investigator Masoom J. Desai, MD, FACNS, an assistant professor in the department of neurology at the University of New Mexico School of Medicine, said in a statement.¹

The Ceribell POC-EEG system delivers real-time seizure monitoring with around-the-clock alerts, enabling more precise treatment of patients with suspected nonconvulsive seizures. In Ceribell’s new software, ClarityPro, was granted 510(k) clearance for the diagnosis of electrographic status epilepticus in adults over the age of 18, becoming the first such tool available. Subsequently, the US Centers for Medicare and Medicaid Services (CMS) gave new technology add-on payment (NTAP) for ClarityPro for up to $913.90 per eligible Medicare patient case.³

The subanalysis featured patient records from January 2018 to June 2022 at 3 different academic centers, focused on EEG timing and clinical outcomes. Propensity score matching was applied using key clinical covariates to control for confounders. In addition to showing short median ICU LOS and decreased mRS scores, use of the POC-EEG system resulted in 19 hours faster median time to EEG acquisition. In comparison, investigators reported median times of 5.9 hours with Ceribell vs 25.3 hours with conventional EEG.²

Jane Chao, PhD

"These study results underscore the critical need for early assessment with point-of-care EEG, and the ability for providers to improve patient care while reducing length of stay and strain on hospital personnel through use of the Ceribell system," Jane Chao, PhD, cho-founder and chief executive officer at Ceribell, said in a statement.¹ "The meaningful association between frontline access to Ceribell's point-of-care EEG and improved patient outcomes will continue to drive our commitment to revolutionizing neurodiagnostics."

The original SAFER-EEG study, published in Neurology, showed that use with the POC-EEG system is comparable in performance to conventional EEG in predicting seizure risk for acutely ill patients using the 2HELPS2B score. Overall, 2HELPS2B on a 1-hour rapid-response EEG met noninferiority to conventional EEG (area under the curve [AUC], 0.85; 95% CI, 0.78-0.90; P = .001).⁴

Additional data on secondary end points comparing a matched contemporaneous cEEG showed no significant difference in AUC (0.89, 95% CI 0.83–0.94, p = 0.31); in false negative rate for the 2HELPS2B = 0 group (p = 1.0) rrEEG (0.021, 95% CI 0–0.062), cEEG (0.016, 95% CI 0–0.048); nor in survival analyses. Study investigators concluded that those with low-risk (2HELPS2B = 0) may be able to forgo prolonged conventional EEG, allowing for increased monitoring of at-risk patients.

Ceribell’s ClarityPro was previously assessed in a retrospective study called CLARITY, published in Neurocritical Care in 2021, that spanned 6 hospitals with 1052 hours of EEG examined. A majority of the neurologists labeled the EEGs as normal or slow activity (n = 249), highly epileptiform patterns (HEP; n = 87) or seizures (n = 17; 9 longer than 5 minutes and 8 shorter than 5 minutes). Findings showed that ClarityPro detected more than 90% of seizure burden, thereby triggering an alert for impending status epilepticus, in 9 out of 9 cases, equating to a 100% sensitivity. Of the 179 EEG recordings in which Clarity detected no seizures, seizures were identified by the expert reviewers in only 2 cases. In both cases, the seizures were less than 30 seconds in duration, indicating a negative predictive value of 99%.⁵

REFERENCES
1. Ceribell Announces Publication of Study Demonstrating Significant Reduction in Length of ICU Stays and Better Patient Outcomes with Ceribell Point-of-Care EEG Compared to Conventional EEG. News release. Ceribell. July 23, 2024. Accessed August 8, 2024. https://www.prnewswire.com/news-releases/ceribell-announces-publication-of-study-demonstrating-significant-reduction-in-length-of-icu-stays-and-better-patient-outcomes-with-ceribell-point-of-care-eeg-compared-to-conventional-eeg-302203966.html
2. Desai M, Kalkach-Aparicio M, Sheikh IS, et al. Evaluating the Impact of Point-of-Care Electroencephalography on Length of Stay in the Intensive Care Unit: Subanalysis of the SAFER-EEG Trial. Neurocritical Care. Published online July 9, 2024. doi: 10.1007/s12028-024-02039-6
3. Ceribell recieves FDA 510(k) clearance and CMS NTAP reimbursement for New ClarityPro Software with electrographic status epilepticus diagnostic indication. Ceribell. August 3, 2023. Accessed August 8, 2024. https://www.prnewswire.com/news-releases/ceribell-receives-fda-510k-clearance-and-cms-ntap-reimbursement-for-new-claritypro-software-with-electrographic-status-epilepticus-diagnostic-indication-301892676.html
4. Kalkach-Aparicio M, Fatima S, Selte A, et al. Seizure Assessment and Forecasting With Efficient Rapid-EEG: A Retrospective Multicenter Comparative Effectiveness Study. Neurology. 2024;103(2). doi:10.1212/WNL.0000000000209621
5. Kamousi B, Karunakaran S, Gururangan K, et al. Monitoring the burden of seizures and highly epileptiform patterns in critical care with a novel machine learning method. Neurocritical Care. 2021;34:908-917. doi:10.1007/s12028-020-01120-0