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.
Study Type
OBSERVATIONAL
Enrollment
164
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.
University of California Los Angeles
Los Angeles, California, United States
Rush University Medical Center Pob
Chicago, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Change in physicians' diagnosis decision
Physician will record their diagnostic assessment of seizure in Yes or No.
Time frame: 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
Time frame: through study completion, an average of 1 year
Change in physicians' treatment decision
Physician will record their treatment decision in Yes or No.
Time frame: 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
Time frame: through study completion, an average of 1 year
Time from order to EEG arrival
Time from EEG order to EEG arrival will be recorded for both Ceribell EEG and conventional EEG
Time frame: 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
Time frame: through study completion, an average of 1 year
Ease of use
Ease of use will be recorded with a score of 1-5
Time frame: 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
Time frame: through study completion, an average of 1 year
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