Does Use of Rapid Response EEG Impact Clinical Decision Making

Completed

• Conditions: Nonconvulsive Status Epilepticus; Seizures

• Registration Number: NCT03534258
• Lead Sponsor: Ceribell Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-19
• Study Start: 2018-04-30
• Study First Submitted QC: 2018-05-11
• Study First Posted: 2018-05-23
• Primary Completion: 2019-04-30
• Study Completion: 2019-07-31
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-16
• Last Update Posted: 2019-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164

Inclusion Criteria

• Patients undergoing clinically ordered EEGs.

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (5)

University of California Los Angeles; 🇺🇸 Los Angeles, California, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Rush University Medical Center Pob; 🇺🇸 Chicago, Illinois, United States

Wake Forest Baptist Health; 🇺🇸 Winston-Salem, North Carolina, United States

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States