Putting Electroencephalography (EEG) in the Emergency Department
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Purpose
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.
| Condition |
|---|
|
Altered Mental Status Generalized Nonconvulsive Seizure Disorder Status-epilepticus |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Diagnostic Utility of Emergency Electroencephalography in Identifying Non-convulsive Seizure and Subclinical Status Epilepticus in Patients With Altered Mental Status |
- 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 ] [ Designated as safety issue: No ]
- 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
| Enrollment: | 261 |
| Study Start Date: | April 2011 |
| Study Completion Date: | February 2012 |
| Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
A total of 260 patients will be recruited for the study. Adult and pediatric patients ≥ 13 year-old with AMS on arrival to ED
Inclusion Criteria:
ED patients ≥ 13 year-old with AMS on arrival to ED
Exclusion Criteria:
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.
Contacts and Locations| United States, New York | |
| 450 Clarkson Avenue | |
| Brooklyn, New York, United States, 11203 | |
| Principal Investigator: | Shahriar Zehtabchi, MD | Recruiting |
More Information
No publications provided
| Responsible Party: | Bio-Signal Group Corp. |
| ClinicalTrials.gov Identifier: | NCT01355211 History of Changes |
| Other Study ID Numbers: | RC3NS070658, RC3NS070658 |
| Study First Received: | May 16, 2011 |
| Last Updated: | February 29, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Bio-Signal Group Corp.:
|
Altered Mental Status non-convulsive seizure status epilepticus electroencephalography |
Additional relevant MeSH terms:
|
Emergencies Epilepsy Epilepsy, Generalized Seizures Status Epilepticus Mental Disorders Disease Attributes |
Pathologic Processes Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013