An observational study in Nonconvulsive Status Epilepticus and Seizures, sponsored by Ceribell Inc.. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-20.
Sponsored by Ceribell Inc. · Observational
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.
124 studies on the registry are indexed under Status Epilepticus; 37 are open to participants now.
This study's enrollment of 164 is close to the median of 156 across 42 observational studies indexed under Status Epilepticus.
Browse Status Epilepticus studies →Ceribell Inc. is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study will involve two groups of subjects:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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
Plan to share: No
Ran from Apr 2018 to primary completion in Apr 2019, 12 months.
Of 20 observational studies under Status Epilepticus, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 14. This study's 12 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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