Clinical Data and Supporting Evidence: ClarityTM Study

Fast. Accurate. Informed. Clear.

CERIBELL WITH CLARITY WAS DEMONSTRATED TO DIFFERENTIATE EEGS WITH AND WITHOUT STATUS EPILEPTICUS WITH HIGH SENSITIVITY AND SPECIFICITY.

Results from the Clarity study were published in Neurocritical Care journal.

Monitoring the Burden of Seizures and Highly Epileptiform Patterns in Critical Care with a Novel Machine Learning Method

Neurocritical Care. doi: 10.1007 s12028-020-01120-0, October 2020

Published by:
Baharan Kamousi, Suganya Karunakaran, Kapil Gururangan, Matthew Markert, Barbara Decker, Pouya Khankhanian, Laura Mainardi, James Quinn, Raymond Woo and Josef Parvizi

Retrospective assessment of 353 adult patients who underwent evaluation of possible seizures with Point-of-Care EEG system

The study assessed the performance of Ceribell
with Clarity to triage seizure activity in critical care
and emergency department settings

Expert consensus

Majority agreement EEG reading from multiple EEG experts

Clarity

Ceribell with Clarity EEG interpretation

Current standard of care

Individual epileptologist’s EEG reading

Clarity for detection of status epilepticus

Clarity detected ≥ 90% seizure
burden, thereby triggering an alert for impending status epilepticus, in 9 out of 9 cases (100% sensitivity)

Clarity for ruling out seizure

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.

  • 10% of EEGs resulted in a bedside alert (had a
    seizure burden ≥ 90%)
  • 33% of EEGs had seizure or epileptiform
    abnormalities that did not result in a bedside
    alert (seizure burden between 1%-90%)
  • 57% of EEGs were identified as normal or slow
    (0% seizure burden)

All 4 neurologists have fellowship training in epilepsy

Variability in Status Epilepticus Detection

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Caution: Federal (US) law restricts this device to sale by or on the order of a physician. The Ceribell EEG Headband and the Ceribell EEG Recorder are intended to be used by trained healthcare providers in a professional healthcare facility environment. The Ceribell EEG Recorder does not provide any diagnostic conclusion about the subject’s condition and does not provide any automated alerts of an adverse clinical event. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device.

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