Nonconvulsive Status Epilepticus, Seizures
Conditions
Brief summary
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.
Interventions
DEVICECeribell 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.
Sponsors
Ceribell Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing clinically ordered EEGs.
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in physicians' treatment confidence | through study completion, an average of 1 year | Physician will rate their treatment confidence with a score between 1 to 5 |
| Change in physicians' diagnosis decision | through study completion, an average of 1 year | Physician will record their diagnostic assessment of seizure in Yes or No. |
| Change in physicians' diagnosis confidence | through study completion, an average of 1 year | Physician will rate their diagnosis confidence with a score between 1 to 5 |
| Change in physicians' treatment decision | through study completion, an average of 1 year | Physician will record their treatment decision in Yes or No. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time from order to EEG arrival | through study completion, an average of 1 year | Time from EEG order to EEG arrival will be recorded for both Ceribell EEG and conventional EEG |
| Set up time | through study completion, an average of 1 year | Time from EEG arrival to the first EEG recording will be recorded for both Ceribell EEG and conventional EEG |
| Ease of use | through study completion, an average of 1 year | Ease of use will be recorded with a score of 1-5 |
| Signal Quality of EEG | through study completion, an average of 1 year | 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 |
Countries
United States
Outcome results
None listed