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CompletedNCT01355211Updated Mar 2, 2012

Putting Electroencephalography (EEG) in the Emergency Department

An observational study in Altered Mental Status, Generalized Nonconvulsive Seizure Disorder and Status-epilepticus, sponsored by Bio-Signal Group Corp.. Completed at 1 site in United States. Open to participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2012-03-02.

Sponsored by Bio-Signal Group Corp. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
261
Ages
13 Years and older
Sex
All
01

Study 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 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):

  1. AMS alone
  2. AMS with non-specific motor activity (subtle motor movement such as eye blinking, nystagmus, focal motor movements, or myoclonus)
  3. 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.

02

Conditions studied

  • Altered Mental Status
  • Generalized Nonconvulsive Seizure Disorder
  • Status-epilepticus

Keywords

  • Altered Mental Status
  • non-convulsive seizure
  • status epilepticus
  • electroencephalography
03

In context

Epilepsy, Generalized

39 studies on the registry are indexed under Epilepsy, Generalized; 4 are open to participants now.

This study's enrollment of 261 is above the median of 80 across 13 observational studies indexed under Epilepsy, Generalized.

Browse Epilepsy, Generalized studies →

Lead sponsor

Bio-Signal Group Corp. is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

ED patients ≥ 13 year-old with AMS on arrival to ED

Exclusion criteria

Exclusion Criteria:

  1. 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
  2. Patients who cannot undergo EEG recordings because of severe head and injury, hemodynamic instability, transfer to operating room, etc.)
  3. Hemodynamically unstable patients (SBP \< 90 mmHg)
  4. Uncooperative or combative patients on whom the EEG simply cannot be obtained.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
261 participants (actual)
06

What researchers measure

Primary outcomes

  1. Diagnostic Utility of Emergency Electroencephalography in Identifying Non-convulsive Seizure and Subclinical Status Epilepticus in Patients with Altered Mental Status (AMS)

    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

    Time frame: 6 months

07

Study locations

1 site
  • 450 Clarkson Avenue
    Brooklyn, New York 11203, United States
08

References and documents

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 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2011, a primary completion of Feb 2012 and a completion of Feb 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 16, 2011
First posted
May 18, 2011
Start
Apr 2011
Primary completionActual
Feb 2012
CompletionActual
Feb 2012
Last update
Mar 2, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 2, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01355211
Lead sponsor
Bio-Signal Group Corp.
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
First posted
May 18, 2011
Start date
Apr 2011
Primary completion
Feb 2012
Completion
Feb 2012
Last update
Mar 2, 2012

Study contacts

Shahriar Zehtabchi, MD
principal investigator · Recruiting

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.

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Discussion

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Bio-Signal Group Corp.

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