Does Use of Rapid Response EEG Impact Clinical Decision Making (DECIDE)

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.

Study Overview

• Status: Completed
• Conditions: Seizures; Nonconvulsive Status Epilepticus
• Intervention / Treatment: Device: Ceribell Rapid Response EEG, Survey

• Study Type: Observational
• Enrollment (Actual): 164

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90024
      • University of California Los Angeles
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center Pob
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Health
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study will involve two groups of subjects:

1. Physicians (faculty and trainees), who will be asked to fill out a nonsensitive questionnaire. These are members of Epilepsy and Neuro-ICU team (attendings, fellows, or residents) who are actively involved in the care of patients and know the patient's history of present illness.
2. Patients undergoing clinically ordered EEGs.

Description

Inclusion Criteria:

• Patients undergoing clinically ordered EEGs.

Exclusion Criteria:

• None

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Change in physicians' treatment decision	Physician will record their treatment decision in Yes or No.	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	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Ease of use	Ease of use will be recorded with a score of 1-5	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	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Ceribell Inc.

Publications and helpful links

General Publications

• Vespa PM, Olson DM, John S, Hobbs KS, Gururangan K, Nie K, Desai MJ, Markert M, Parvizi J, Bleck TP, Hirsch LJ, Westover MB. Evaluating the Clinical Impact of Rapid Response Electroencephalography: The DECIDE Multicenter Prospective Observational Clinical Study. Crit Care Med. 2020 Sep;48(9):1249-1257. doi: 10.1097/CCM.0000000000004428.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 30, 2018
• Primary Completion (ACTUAL): April 30, 2019
• Study Completion (ACTUAL): July 31, 2019

Study Registration Dates

• First Submitted: April 19, 2018
• First Submitted That Met QC Criteria: May 11, 2018
• First Posted (ACTUAL): May 23, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 20, 2019
• Last Update Submitted That Met QC Criteria: August 16, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Seizures; Status Epilepticus
• Other Study ID Numbers: 1825

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes