Seizures Clinical Trial
— DECIDEOfficial title:
Does Use of Rapid Response EEG Impact Clinical Decision Making
NCT number | NCT03534258 |
Other study ID # | 1825 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 30, 2018 |
Est. completion date | July 31, 2019 |
Verified date | August 2019 |
Source | Ceribell Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | 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.
Status | Completed |
Enrollment | 164 |
Est. completion date | July 31, 2019 |
Est. primary completion date | April 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients undergoing clinically ordered EEGs. Exclusion Criteria: - None |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | Rush University Medical Center Pob | Chicago | Illinois |
United States | University of Texas Southwestern Medical Center | Dallas | Texas |
United States | University of California Los Angeles | Los Angeles | California |
United States | Wake Forest Baptist Health | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Ceribell Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | Change in physicians' treatment decision | Physician will record their treatment decision in Yes or No. | through study completion, an average of 1 year | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | Ease of use | Ease of use will be recorded with a score of 1-5 | through study completion, an average of 1 year | |
Secondary | 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 |
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