Does Use of Rapid Response EEG Impact Clinical Decision Making

Seizures Clinical Trial

— DECIDE  

Official title:

Does Use of Rapid Response EEG Impact Clinical Decision Making

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03534258
• Other study ID #: 1825
• Status: Completed
• Start date: April 30, 2018
• Est. completion date: July 31, 2019

Study information

• Verified date: August 2019
• Source: Ceribell Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Nonconvulsive Status Epilepticus
• Seizures
• Status Epilepticus

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Ceribell Inc.

Country where clinical trial is conducted

United States, 

Outcome

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