Altered Mental StatusNCT01355211
Putting Electroencephalography (EEG) in the Emergency Department
An observational study of Altered Mental Status and Generalized Nonconvulsive Seizure Disorder, run by Bio-Signal Group Corp. at 1 site in United States.
Trial summary
The aim of the proposed research is to compare the diagnostic accuracy of a portable wireless electroencephalography (EEG) device (Biosignal Micro-EEG) to standard EEG in identifying abnormal EEG patterns (mainly non-convulsive seizure and non-convulsive status epilepticus) in emergency department (ED) patients with… Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Altered Mental Status, Generalized Nonconvulsive Seizure Disorder, Status-epilepticus
- How many people
- 261 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Feb 2012
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: A total of 260 patients will be recruited for the study. Adult and pediatric patients ≥ 13 year-old with AMS on arrival to ED
Who may be able to join
- ED patients ≥ 13 year-old with AMS on arrival to ED
Who cannot join
- Patients with apparent and immediately correctable cause of AMS upon presentation (determined by ED attending physician during initial evaluation):
- Patients with finger stick or serum glucose less than 60 mg/dl
- Patients with hypothermia
- Patients with hyperthermia, heat exhaustion or heat stroke
- Patients with opioid overdose responding to Narcan
- Patients who cannot undergo EEG recordings because of severe head and injury, hemodynamic instability, transfer to operating room, etc.)
- Hemodynamically unstable patients (SBP < 90 mmHg)
- Uncooperative or combative patients on whom the EEG simply cannot be obtained.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Utility of Emergency Electroencephalography in Identifying Non-convulsive Seizure and Subclinical Status Epilepticus in Patients With Altered Mental Status
The aim of the proposed research is to compare the diagnostic accuracy of a portable wireless electroencephalography (EEG) device (Biosignal Micro-EEG) to standard EEG in identifying abnormal EEG patterns (mainly non-convulsive seizure and non-convulsive status epilepticus) in emergency department (ED) patients with altered mental status. Comparing the the accuracy of EEG recordings and interpretations of Micro-EEG to those of standard EEG will allow the investigators to assess the utility of this novel device in the ED patients with altered mental status. The unique qualities of Micro-EEG device could potentially facilitate easier access to EEG test in all ED patients.
This study will also provide valid information regarding the prevalence of non-convulsive seizure in ED patients with altered mental status.The gold standard for diagnosing non-convulsive seizure would be standard EEG.
All study participants will undergo electroencephalography using the two devices (standard EEG and micro-EEG) and a combination of standard electrodes and Electro-Cap in a randomized order: 1. Standard EEG with standard EEG electrodes, 2. Micro-EEG with standard EEG electrodes, and 3. Micro-EEG with Electro-Cap electrodes.
Read the detailed description
Formulated Research Question:
Population: ED patients with altered mental status (AMS) Intervention: Micro-EEG Comparison: Standard EEG Outcomes: 1. Sensitivity, specificity, positive/negative likelihood ratios of micro-EEG in identifying non-convulsive seizures and abnormal brain activities 2. The concordance of EEG interpretations between micro-EEG and standard EEGs recordings Design Prospective cross-sectional
Definitions:
Altered Mental Status: Any acute change in level of arousability or responsiveness (e.g. confusion, lethargy, delirium, coma, aphasia, disinhibition, labile/blunted affect or unexpected psychosis).
Types of AMS (for the purpose of the study):
- AMS alone
- AMS with non-specific motor activity (subtle motor movement such as eye blinking, nystagmus, focal motor movements, or myoclonus)
- Prolonged AMS following one or more tonic-clonic seizures suggesting status epilepticus Non-convulsive seizure (NCZ):A seizure without clonic or tonic activity or other convulsive motor activity.
Status Epilepticus (SE):SE is defined as 1. More than 30 minutes of continuous seizure activity or 2. Two or more sequential seizures without recovery of consciousness between seizures.
- Keywords
- Altered Mental Status, non-convulsive seizure, status epilepticus, electroencephalography
- Medical subject headings
- Epilepsy, Generalized, Status Epilepticus
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Utility of Emergency Electroencephalography in Identifying Non-convulsive Seizure and Subclinical Status Epilepticus in Patients with Altered Mental Status (AMS)
- Sensitivity, specificity, positive/negative likelihood ratios of micro-EEG in identifying non-convulsive seizures and abnormal brain activities
- The concordance of EEG interpretations between micro-EEG and standard EEG recordings
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2011 (estimated)
- Study startApr 2011
- Primary completionFeb 2012
- Study completionFeb 2012
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 Altered Mental StatusStudies 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
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bio-Signal Group Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), State University of New York - Downstate Medical Center, Kings County Hospital Department of Emergency Medicine
- Responsible party
- Sponsor
- Investigators
- Shahriar Zehtabchi, MD, Principal investigator, Recruiting
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01355211
- Sponsor's protocol ID
- RC3NS070658
- Other IDs
- RC3NS070658
- Status last verified
- Feb 2012
- First submitted
- 16 May 2011
- Last updated
- 2 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zehtabchi S, Abdel Baki SG, Omurtag A, Sinert R, Chari G, Malhotra S, Weedon J, Fenton AA, Grant AC. Prevalence of non-convulsive seizure and other electroencephalographic abnormalities in ED patients with altered mental status. Am J Emerg Med. 2013 Nov;31(11):1578-82. doi: 10.1016/j.ajem.2013.08.002. Epub 2013 Sep 23.
PubMed 24070982
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Utility of Emergency Electroencephalography in Identifying Non-convulsive Seizure and Subclinical Status Epilepticus in Patients With Altered Mental Status
- ClinicalTrials.gov ID
- NCT01355211
- Acronym / sponsor ID
- RC3NS070658
- Keywords
- Altered Mental Status, non-convulsive seizure, status epilepticus, electroencephalography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- Bio-Signal Group Corp.Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), State University of New York - Downstate Medical Center, Kings County Hospital Department of Emergency Medicine
- Study start
- Apr 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 18 May 2011 (estimated)
- 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.
The aim of the proposed research is to compare the diagnostic accuracy of a portable wireless electroencephalography (EEG) device (Biosignal Micro-EEG) to standard EEG in identifying abnormal EEG patterns (mainly non-convulsive seizure and non-convulsive status epilepticus) in emergency department (ED) patients with altered mental status. Comparing the the accuracy of EEG recordings and interpretations of Micro-EEG to those of standard EEG will allow the investigators to assess the utility of this novel device in the ED patients with altered mental status. The unique qualities of Micro-EEG device could potentially facilitate easier access to EEG test in all ED patients.
This study will also provide valid information regarding the prevalence of non-convulsive seizure in ED patients with altered mental status.The gold standard for diagnosing non-convulsive seizure would be standard EEG.
All study participants will undergo electroencephalography using the two devices (standard EEG and micro-EEG) and a combination of standard electrodes and Electro-Cap in a randomized order: 1. Standard EEG with standard EEG electrodes, 2. Micro-EEG with standard EEG electrodes, and 3. Micro-EEG with Electro-Cap electrodes.
Detailed description
Formulated Research Question:
Population: ED patients with altered mental status (AMS) Intervention: Micro-EEG Comparison: Standard EEG Outcomes: 1. Sensitivity, specificity, positive/negative likelihood ratios of micro-EEG in identifying non-convulsive seizures and abnormal brain activities 2. The concordance of EEG interpretations between micro-EEG and standard EEGs recordings Design Prospective cross-sectional
Definitions:
Altered Mental Status: Any acute change in level of arousability or responsiveness (e.g. confusion, lethargy, delirium, coma, aphasia, disinhibition, labile/blunted affect or unexpected psychosis).
Types of AMS (for the purpose of the study):
- AMS alone
- AMS with non-specific motor activity (subtle motor movement such as eye blinking, nystagmus, focal motor movements, or myoclonus)
- Prolonged AMS following one or more tonic-clonic seizures suggesting status epilepticus Non-convulsive seizure (NCZ):A seizure without clonic or tonic activity or other convulsive motor activity.
Status Epilepticus (SE):SE is defined as 1. More than 30 minutes of continuous seizure activity or 2. Two or more sequential seizures without recovery of consciousness between seizures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A total of 260 patients will be recruited for the study. Adult and pediatric patients ≥ 13 year-old with AMS on arrival to ED
Key inclusion criteria (1 listed)
- ED patients ≥ 13 year-old with AMS on arrival to ED
Key exclusion criteria (8 listed)
- Patients with apparent and immediately correctable cause of AMS upon presentation (determined by ED attending physician during initial evaluation):
- Patients who cannot undergo EEG recordings because of severe head and injury, hemodynamic instability, transfer to operating room, etc.)
- Hemodynamically unstable patients (SBP < 90 mmHg)
- Uncooperative or combative patients on whom the EEG simply cannot be obtained.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic Utility of Emergency Electroencephalography in Identifying Non-convulsive Seizure and Subclinical Status Epilepticus in Patients with Altered Mental Status (AMS)
Time frame: 6 months
1. Sensitivity, specificity, positive/negative likelihood ratios of micro-EEG in identifying non-convulsive seizures and abnormal brain activities 2. The concordance of EEG interpretations between micro-EEG and standard EEG recordings
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 2 Mar 2012.
- Derived from this study: PubMed 24070982Zehtabchi S, Abdel Baki SG, Omurtag A, Sinert R, Chari G, Malhotra S, Weedon J, Fenton AA, Grant AC. Prevalence of non-convulsive seizure and other electroencephalographic abnormalities in ED patients with altered mental status. Am J Emerg Med. 2013 Nov;31(11):1578-82. doi: 10.1016/j.ajem.2013.08.002. Epub 2013 Sep 23.
Related trials for Altered Mental Status
Enrolling by invitationObservational study
Pre-hospital Ventilation Clinical Study
Altered Mental Status, Sepsis
Enrolling by invitationObservational study
Relationship Between Selected Parameters and Bruxism
Sleep Bruxism, Sleep Disorder
Enrolling by invitationObservational study
Selected Disorders and Sleep Bruxism
Sleep Bruxism, Hypertension
Recruiting
Researching Efficient Approaches to Delirium Identification-Sustaining Effective Translation
Delirium, Delirium in Old Age
Enrolling by invitation
Sun-Kissed Serenity: Morning Rays for a Brighter Mind
Mental Status Change
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.
Shahriar Zehtabchi, MD principal investigator
Recruiting
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Altered Mental Status and Generalized Nonconvulsive Seizure Disorder, run by Bio-Signal Group Corp. at 1 site 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 8 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 2 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Diagnostic Utility of Emergency Electroencephalography in Identifying Non-convulsive Seizure and Subclinical Status Epilepticus in Patients with Altered Mental Status (AMS) (time frame: 6 months). 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 NCT01355211, 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 2 Mar 2012.