<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01671475</url>
  </required_header>
  <id_info>
    <org_study_id>EDEEG</org_study_id>
    <secondary_id>RC3NS070658</secondary_id>
    <nct_id>NCT01671475</nct_id>
  </id_info>
  <brief_title>Putting Electroencephalography (EEG) in the Emergency Department</brief_title>
  <official_title>Impact of microEEG on Clinical Management and Outcomes of Emergency Department (ED) Patients With Altered Mental Status</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bio-Signal Group Corp.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Neurological Disorders and Stroke (NINDS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>State University of New York - Downstate Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kings County Hospital Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Bio-Signal Group Corp.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The proposed study aims to test the impact of microEEG on clinical management (diagnosis and&#xD;
      treatment) of emergency department patients with Altered Mental Status (AMS). The study will&#xD;
      utilize a portable, wireless, FDA-approved device (microEEG) as the intervention. Patients&#xD;
      will be randomized to routine care plus microEEG (experimental arm) or routine care alone&#xD;
      (control arm). The investigators hypothesize that incorporating microEEG in the work up of&#xD;
      patients with AMS will impact the clinical management of these patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Approximately, 4% and 10% of emergency department (ED) patients in the United States present&#xD;
      with altered mental status (AMS). According to previous studies, close to 30% of AMS cases&#xD;
      occur due to neurological etiologies. Among these pathologies are non-convulsive seizures&#xD;
      (NCS) and non-convulsive status epilepticus (NCSE). In our previous study, the investigators&#xD;
      established that approximately 4% (95% confidence interval, 2-8%) of ED patients with AMS&#xD;
      suffer from NCS and NCSE. Our study also revealed that 78% of the ED patient with AMS have&#xD;
      some form of EEG abnormality.&#xD;
&#xD;
      NCS and NCSE are difficult to diagnose especially in AMS patients because performing a&#xD;
      thorough physical examination or obtaining medical history is often impossible in altered&#xD;
      patients. Definitive diagnosis of NCS/NCSE requires electroencephalography (EEG), a test that&#xD;
      records brain electrical activity and provides information about the brain function.&#xD;
&#xD;
      Unfortunately, obtaining an EEG in the ED can be challenging. This requires transporting an&#xD;
      EEG machine to patient's bedside, where space limitations and presence of variety of monitors&#xD;
      and devices, especially in over-crowded EDs render this practice difficult. In many&#xD;
      institutions an EEG service is not offered after work hours due to the unavailability of 24/7&#xD;
      EEG technologist coverage and real-time electroencephalographer interpretation. As a result&#xD;
      of the aforementioned limitations, ED physicians may refrain from ordering EEG.&#xD;
&#xD;
      The wireless portable EEG device (microEEG) designed by the Bio-Signal Group was designed to&#xD;
      address these limitations. With minimal training, ED personnel could use this small, microEEG&#xD;
      device to obtain an EEG. The recording then can be wirelessly transmitted to a host computer&#xD;
      via a secure network connection to the neurology experts who could interpret the EEG.&#xD;
      Incorporating microEEG in the initial workup of patients with AMS could help the ED attending&#xD;
      rule out NCS/NCSE and focus on other diagnoses. Alternatively, if the presence of NCS is&#xD;
      confirmed by EEG, the treatment could be initiated early and potentially reduce morbidity or&#xD;
      mortality.&#xD;
&#xD;
      The investigators hypothesize that incorporating EEG in the work of ED patients with AMS&#xD;
      could impact the management(diagnosis and treatment)of these patients and influence their&#xD;
      clinical outcome.&#xD;
&#xD;
      Sample size: Our sample size analysis using data one published related study reveled that the&#xD;
      study would need 65 patients in each group (total n:130). However, the investigators plan to&#xD;
      perform an interim analysis after enrolling half of this target sample and adjust the sample&#xD;
      size calculation based on the collected data if necessary.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of ED management</measure>
    <time_frame>4-6 hours of arrival</time_frame>
    <description>Primary outcome: Change in management (Diagnosis and Therapy)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Other Outcomes</measure>
    <time_frame>From date of randomization until the date of discharge from the hospital or date of in-hospital death from any cause, whichever comes first, assessed up to 90 days</time_frame>
    <description>Secondary Outcome: Length of stay in Hospital, Length of stay in ED, In-hospital mortality, Type of ED Disposition and Type of hospital disposition.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">149</enrollment>
  <condition>Altered Mental Status</condition>
  <arm_group>
    <arm_group_label>Routine care plus microEEG</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects allocated to this group will undergo an EEG using microEEG device in addition to their routine care. The microEEG device will be used with commercially available electrodes in a headpiece configuration.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Routine care only (control group)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subjects allocated to the control group will receive routine care without microEEG. The treating physician may request a standard EEG, which will be performed by the hospital EEG laboratory, if available.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>microEEG (Bio-Signal microEEG)</intervention_name>
    <description>At the core, the Bio-Signal microEEG, is an FDA approved miniature, battery-operated, multi-channel, and portable system that records wideband bioelectric signals. The microEEG combines the characteristics of low noise and small size, due to a number of fundamental design characteristics. It records, amplifies, and digitizes the signals at a point very close to the electrodes. This allows the length of the wires between electrodes and the recorder's amplifiers to be very short, keeping them out of the way. Short wires also reduce any inconvenience signal artifacts or other problems that may be associated with the length of the wires. The microEEG's dimensions are about 2&quot;x2&quot;x1&quot;.</description>
    <arm_group_label>Routine care plus microEEG</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        ED patients ≥ 18 years old with AMS.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with apparent and immediately correctable cause of AMS (determined by ED&#xD;
             attending during initial evaluation) that include:&#xD;
&#xD;
               -  Fingerstick or serum glucose less than 60mg/dl&#xD;
&#xD;
               -  Hypothermia (Hypothermia is defined as any body temperature below 35.0 C [95.0&#xD;
                  F]).&#xD;
&#xD;
               -  Hyperthermia, heat exhaustion or heat stroke&#xD;
&#xD;
               -  Opioid overdose responding to Narcan.&#xD;
&#xD;
          2. Patients who cannot undergo EEG recordings for any reason (e.g. severe scalp injury).&#xD;
&#xD;
          3. Hemodynamically unstable patients(SBP &lt;90mm Hg)&#xD;
&#xD;
          4. Patients who are uncooperative or combative.&#xD;
&#xD;
          5. Patients transferred out of ED before enrollment.&#xD;
&#xD;
          6. Patients with obvious tonic-clonic or focal seizures in the ED.&#xD;
&#xD;
        Note: Patients with hypoglycemia who do not return to their baseline level of mental status&#xD;
        within 30 minutes of correcting their blood glucose level, will be enrolled. Similarly,&#xD;
        patients who had an obvious seizure in the ED but do not return to their baseline mental&#xD;
        status within 15 minutes will also be enrolled.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shahriar Zehtabchi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Physician</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kings County Hospital Center</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SUNY Downstate Medical Center</name>
      <address>
        <city>Brookyln</city>
        <state>New York</state>
        <zip>11203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2013</verification_date>
  <study_first_submitted>August 4, 2012</study_first_submitted>
  <study_first_submitted_qc>August 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 23, 2012</study_first_posted>
  <last_update_submitted>February 13, 2013</last_update_submitted>
  <last_update_submitted_qc>February 13, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 15, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Altered Mental Status</keyword>
  <keyword>Non-convulsive seizure</keyword>
  <keyword>Electroencephalography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</mesh_term>
    <mesh_term>Mental Disorders</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>October 30, 2014</submitted>
    <returned>November 4, 2014</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01671475
org study id: EDEEG
secondary id: RC3NS070658
nct id: NCT01671475
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The proposed study aims to test the impact of microEEG on clinical management (diagnosis and
      treatment) of emergency department patients with Altered Mental Status (AMS). The study will
      utilize a portable, wireless, FDA-approved device (microEEG) as the intervention. Patients
      will be randomized to routine care plus microEEG (experimental arm) or routine care alone
      (control arm). The investigators hypothesize that incorporating microEEG in the work up of
      patients with AMS will impact the clinical management of these patients.
Approximately, 4% and 10% of emergency department (ED) patients in the United States present
      with altered mental status (AMS). According to previous studies, close to 30% of AMS cases
      occur due to neurological etiologies. Among these pathologies are non-convulsive seizures
      (NCS) and non-convulsive status epilepticus (NCSE). In our previous study, the investigators
      established that approximately 4% (95% confidence interval, 2-8%) of ED patients with AMS
      suffer from NCS and NCSE. Our study also revealed that 78% of the ED patient with AMS have
      some form of EEG abnormality.

      NCS and NCSE are difficult to diagnose especially in AMS patients because performing a
      thorough physical examination or obtaining medical history is often impossible in altered
      patients. Definitive diagnosis of NCS/NCSE requires electroencephalography (EEG), a test that
      records brain electrical activity and provides information about the brain function.

      Unfortunately, obtaining an EEG in the ED can be challenging. This requires transporting an
      EEG machine to patient's bedside, where space limitations and presence of variety of monitors
      and devices, especially in over-crowded EDs render this practice difficult. In many
      institutions an EEG service is not offered after work hours due to the unavailability of 24/7
      EEG technologist coverage and real-time electroencephalographer interpretation. As a result
      of the aforementioned limitations, ED physicians may refrain from ordering EEG.

      The wireless portable EEG device (microEEG) designed by the Bio-Signal Group was designed to
      address these limitations. With minimal training, ED personnel could use this small, microEEG
      device to obtain an EEG. The recording then can be wirelessly transmitted to a host computer
      via a secure network connection to the neurology experts who could interpret the EEG.
      Incorporating microEEG in the initial workup of patients with AMS could help the ED attending
      rule out NCS/NCSE and focus on other diagnoses. Alternatively, if the presence of NCS is
      confirmed by EEG, the treatment could be initiated early and potentially reduce morbidity or
      mortality.

      The investigators hypothesize that incorporating EEG in the work of ED patients with AMS
      could impact the management(diagnosis and treatment)of these patients and influence their
      clinical outcome.

      Sample size: Our sample size analysis using data one published related study reveled that the
      study would need 65 patients in each group (total n:130). However, the investigators plan to
      perform an interim analysis after enrolling half of this target sample and adjust the sample
      size calculation based on the collected data if necessary.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Outcomes Assessor)
measure: Change of ED management
time frame: 4-6 hours of arrival
description: Primary outcome: Change in management (Diagnosis and Therapy)
measure: Other Outcomes
time frame: From date of randomization until the date of discharge from the hospital or date of in-hospital death from any cause, whichever comes first, assessed up to 90 days
description: Secondary Outcome: Length of stay in Hospital, Length of stay in ED, In-hospital mortality, Type of ED Disposition and Type of hospital disposition.
arm group label: Routine care plus microEEG
arm group type: Experimental
description: Subjects allocated to this group will undergo an EEG using microEEG device in addition to their routine care. The microEEG device will be used with commercially available electrodes in a headpiece configuration.
arm group label: Routine care only (control group)
arm group type: No Intervention
description: Subjects allocated to the control group will receive routine care without microEEG. The treating physician may request a standard EEG, which will be performed by the hospital EEG laboratory, if available.
intervention type: Device
intervention name: microEEG (Bio-Signal microEEG)
description: At the core, the Bio-Signal microEEG, is an FDA approved miniature, battery-operated, multi-channel, and portable system that records wideband bioelectric signals. The microEEG combines the characteristics of low noise and small size, due to a number of fundamental design characteristics. It records, amplifies, and digitizes the signals at a point very close to the electrodes. This allows the length of the wires between electrodes and the recorder's amplifiers to be very short, keeping them out of the way. Short wires also reduce any inconvenience signal artifacts or other problems that may be associated with the length of the wires. The microEEG's dimensions are about 2"x2"x1".
arm group label: Routine care plus microEEG
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Shahriar Zehtabchi, MD
role: Principal Investigator
affiliation: Physician
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Emergencies
mesh term: Mental Disorders
submitted: October 30, 2014
returned: November 4, 2014