Does Use of Rapid Response EEG Impact Clinical Decision Making

Study Overview
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Brief Summary
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This study is designed as a prospective, non-randomized, observational, multicenter clinical trial. The primary aim of this study is to observe if the use of the rapid responds electroencephalography (EEG) system impacts physician decision making. Secondary aims include exploring the safety and performance information of the Ceribell EEG system compared to conventional EEG system. The study will recruit physicians (Faculty physicians and Trainees) at up to five institutions and examine the impact of rapid response EEG when providing care to patients in whom EEG recording has been ordered for clinical reasons.

Official Title
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Does Use of Rapid Response EEG Impact Clinical Decision Making

Conditions
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Nonconvulsive Status Epilepticus, Seizures

Intervention / Treatment
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* Device: Ceribell Rapid Response EEG, Survey


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing clinically ordered EEGs. Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Ceribell Rapid Response EEG, Survey|This trial will qualitatively examine how information from rapid response and conventional EEG data changes physicians' diagnostic suspicion or their treatment decisions and confidence levels. In addition, the results will examine the mean time to EEG lead placement, and ease of use.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in physicians' diagnosis decision | Physician will record their diagnostic assessment of seizure in Yes or No. | through study completion, an average of 1 year | 
| Change in physicians' diagnosis confidence | Physician will rate their diagnosis confidence with a score between 1 to 5 | through study completion, an average of 1 year | 
| Change in physicians' treatment decision | Physician will record their treatment decision in Yes or No. | through study completion, an average of 1 year | 
| Change in physicians' treatment confidence | Physician will rate their treatment confidence with a score between 1 to 5 | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from order to EEG arrival | Time from EEG order to EEG arrival will be recorded for both Ceribell EEG and conventional EEG | through study completion, an average of 1 year | 
| Set up time | Time from EEG arrival to the first EEG recording will be recorded for both Ceribell EEG and conventional EEG | through study completion, an average of 1 year | 
| Ease of use | Ease of use will be recorded with a score of 1-5 | through study completion, an average of 1 year | 
| Signal Quality of EEG | Signal Quality of Ceribell EEG as measured with Hjorth parameters (Hjorth Activity, Hjorth Mobility, Hjorth Complexity) will be compared to signal quality of conventional EEG acquired from the same patients | through study completion, an average of 1 year |