<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/NCT03038191</url>
  </required_header>
  <id_info>
    <org_study_id>CA-EPIPRO-TASMC-HOSP-02</org_study_id>
    <nct_id>NCT03038191</nct_id>
  </id_info>
  <brief_title>Epi-collect: Data Collection During Video EEG Monitoring and at Patient's Home</brief_title>
  <official_title>Epi-collect: Data Collection During Video EEG Monitoring and at Patient's Home</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medial Research Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medial Research Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Epilepsy is a group of neurological disorders characterized by propensity for spontaneous&#xD;
      epileptic seizures. Epileptic seizures are the result of excessive and abnormal nerve cell&#xD;
      activity in the brain. About 0.7-1% of the world population suffers from seizures. The most&#xD;
      common treatment is based on seizure medications that enables about 2/3 of the patients to&#xD;
      control their seizures. However, about 20 million patients worldwide, suffer from&#xD;
      unpredictable seizures without remedy, and are resistant to medication.&#xD;
&#xD;
      In this study EEG and other physiologic signals are collected using wearable sensors, from&#xD;
      Epilepsy patients who are at risk of experiencing seizures. The collected signals will be&#xD;
      used for developing algorithms that may identify pre-seizure and seizure related periods.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Sponsor stopped funding&#xD;
  </why_stopped>
  <start_date type="Actual">March 8, 2017</start_date>
  <completion_date type="Actual">June 30, 2019</completion_date>
  <primary_completion_date type="Actual">December 30, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Successful data collection during hospitalization</measure>
    <time_frame>12 hours daily for up to 5 days</time_frame>
    <description>Continuous recording from wearable sensors of physiologic signals during hospitalization in the video EEG unit</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Successful data collection during at home monitoring</measure>
    <time_frame>12 hours daily for up to 14 days</time_frame>
    <description>Continuous recording from wearable sensors of physiologic signals during at home monitoring</description>
  </primary_outcome>
  <enrollment type="Actual">28</enrollment>
  <condition>Epilepsy</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Neuroelectrics Enobio 8(R)</intervention_name>
    <description>Monitoring</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult epilepsy patients who are admitted to the video EEG unit and are expected to&#xD;
        experience seizures during hospitalization&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;18&#xD;
&#xD;
          -  Known diagnosis of Epilepsy&#xD;
&#xD;
          -  Expected to experience seizures during the period of the study as determined by the&#xD;
             PI.&#xD;
&#xD;
          -  Able to meet with the Sponsor representative at home&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Trauma/broken skin on forehead.&#xD;
&#xD;
          -  Patient can not follow or comply with instructions&#xD;
&#xD;
          -  Patients who are unable to independently provide an informed consent&#xD;
&#xD;
          -  Patients with major psychiatric co-morbidities&#xD;
&#xD;
          -  Patients with psychogenic non-epileptic seizures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Tel Aviv Sourasky Medical Center</name>
      <address>
        <city>Tel Aviv</city>
        <zip>64239</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>September 5, 2021</last_update_submitted>
  <last_update_submitted_qc>September 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tel-Aviv Sourasky Medical Center</investigator_affiliation>
    <investigator_full_name>Firas Fahoum, MD</investigator_full_name>
    <investigator_title>Director, Epilepsy and EEG Service Neurology Division</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epilepsy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03038191
org study id: CA-EPIPRO-TASMC-HOSP-02
nct id: NCT03038191
lead sponsor: 
has dmc: No
Epilepsy is a group of neurological disorders characterized by propensity for spontaneous
      epileptic seizures. Epileptic seizures are the result of excessive and abnormal nerve cell
      activity in the brain. About 0.7-1% of the world population suffers from seizures. The most
      common treatment is based on seizure medications that enables about 2/3 of the patients to
      control their seizures. However, about 20 million patients worldwide, suffer from
      unpredictable seizures without remedy, and are resistant to medication.

      In this study EEG and other physiologic signals are collected using wearable sensors, from
      Epilepsy patients who are at risk of experiencing seizures. The collected signals will be
      used for developing algorithms that may identify pre-seizure and seizure related periods.
observational model: Other
time perspective: Prospective
measure: Successful data collection during hospitalization
time frame: 12 hours daily for up to 5 days
description: Continuous recording from wearable sensors of physiologic signals during hospitalization in the video EEG unit
measure: Successful data collection during at home monitoring
time frame: 12 hours daily for up to 14 days
description: Continuous recording from wearable sensors of physiologic signals during at home monitoring
intervention type: Device
intervention name: Neuroelectrics Enobio 8(R)
description: Monitoring
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Tel-Aviv Sourasky Medical Center
investigator full name: Firas Fahoum, MD
investigator title: Director, Epilepsy and EEG Service Neurology Division
mesh term: Epilepsy
sharing ipd: No