Nonconvulsive Status EpilepticusDECIDENCT03534258
Does Use of Rapid Response EEG Impact Clinical Decision Making
An observational study of Nonconvulsive Status Epilepticus and Seizures, run by Ceribell Inc. at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nonconvulsive Status Epilepticus, Seizures
- What is being tested?
- Ceribell Rapid Response EEG, Survey
- Type of treatment
- Medical device
- How many people
- 164 participants
- Where
- 5 sitesUnited States
- Study dates
- 30 Apr 2018to 31 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients undergoing clinically ordered EEGs.
Who cannot join
- None
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Rush University Medical Center Pob
Chicago, Illinois, 60612
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
University of California Los Angeles
Los Angeles, California, 90024
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
About this study
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.
- Conditions
- Nonconvulsive Status Epilepticus, Seizures
- Being tested
- Ceribell Rapid Response EEG, Survey
- Medical subject headings
- Status Epilepticus, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ceribell Rapid Response EEG, SurveyDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physicians' diagnosis decision
Physician will record their diagnostic assessment of seizure in Yes or No.
Measured: 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
Measured: through study completion, an average of 1 year
Change in physicians' treatment decision
Physician will record their treatment decision in Yes or No.
Measured: 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
Measured: through study completion, an average of 1 year
Secondary outcomes (4)
Time from order to EEG arrival
Time from EEG order to EEG arrival will be recorded for both Ceribell EEG and conventional EEG
Measured: 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
Measured: through study completion, an average of 1 year
Ease of use
Ease of use will be recorded with a score of 1-5
Measured: 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
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start30 Apr 2018
- Primary completion30 Apr 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nonconvulsive Status EpilepticusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ceribell Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03534258
- Sponsor's protocol ID
- 1825
- Acronym
- DECIDE
- Status last verified
- Aug 2019
- First submitted
- 19 Apr 2018
- Last updated
- 20 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 32618687
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Use of Rapid Response EEG Impact Clinical Decision Making
- ClinicalTrials.gov ID
- NCT03534258
- Acronym / sponsor ID
- DECIDE / 1825
- Conditions
- Nonconvulsive Status Epilepticus, Seizures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Ceribell Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Apr 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 23 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients undergoing clinically ordered EEGs.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ceribell Rapid Response EEG, SurveyThis 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. | Device | – |
Primary outcome
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.
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
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.
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
4 secondary outcomes
Time from order to EEG arrival
Time frame: through study completion, an average of 1 year
Set up time
Time frame: through study completion, an average of 1 year
Ease of use
Time frame: through study completion, an average of 1 year
Signal Quality of EEG
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
- Derived from this study: PubMed 32618687Vespa 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nonconvulsive Status Epilepticus and Seizures, run by Ceribell Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in physicians' diagnosis decision (time frame: through study completion, an average of 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03534258, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2019.