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OpenTrials
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NCT Number: NCT03534258

Does Use of Rapid Response EEG Impact Clinical Decision Making

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.

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Key information

Conditions

Nonconvulsive Status Epilepticus Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms Status Epilepticus

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California Los Angeles, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing clinically ordered EEGs.

Exclusion criteria

  • None

Treatment and study plan

Ceribell Rapid Response EEG, Survey

Device

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.

Primary outcomes

  1. Change in physicians' diagnosis decision

    Time frame: through study completion, an average of 1 year

    Physician will record their diagnostic assessment of seizure in Yes or No.

  2. Change in physicians' diagnosis confidence

    Time frame: through study completion, an average of 1 year

    Physician will rate their diagnosis confidence with a score between 1 to 5

  3. Change in physicians' treatment decision

    Time frame: through study completion, an average of 1 year

    Physician will record their treatment decision in Yes or No.

  4. Change in physicians' treatment confidence

    Time frame: through study completion, an average of 1 year

    Physician will rate their treatment confidence with a score between 1 to 5

Secondary outcomes

  1. Time from order to EEG arrival

    Time frame: 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

  2. Set up time

    Time frame: 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

  3. Ease of use

    Time frame: through study completion, an average of 1 year

    Ease of use will be recorded with a score of 1-5

  4. Signal Quality of EEG

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Ceribell Inc.

Industry

Registry information

Acronym: DECIDE

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 23, 2018
Registry last updated
Aug 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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