<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/NCT03251820</url>
  </required_header>
  <id_info>
    <org_study_id>MSESES</org_study_id>
    <nct_id>NCT03251820</nct_id>
  </id_info>
  <brief_title>Management Strategies For Electrical Status Epilepticus During Sleep</brief_title>
  <official_title>Management Strategies for Electrical Status Epilepticus During Sleep</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Randa Abdelbadie Abdelaleem</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Electrical status epilepticus during slow wave sleep is a condition in which the epileptic&#xD;
      patient starts to develop neurocognitive deterioration, any type of seizures and continuous&#xD;
      electrical activity in the EEG during non rapid eye movement sleep. It is an age related&#xD;
      condition and will resolve spontaneously at around the age of puberty. However if left&#xD;
      untreated or treatment is delayed, it may lead to permanent neurocognitive deterioration.&#xD;
      Thus early diagnosis and treatment is essential in these children to preserve neurocognitive&#xD;
      function.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Electrical status epilepticus in sleep (ESES), also known as continuous spikes and waves&#xD;
      during slow sleep (CSWS), is an age related, self - limiting disorder characterized by:&#xD;
&#xD;
        1. epilepsy with different seizure types,&#xD;
&#xD;
        2. neuropsychological regression, and&#xD;
&#xD;
        3. typical EEG pattern of continuous epileptiform activity during non-rapid eye movement&#xD;
           sleep (NREM).&#xD;
&#xD;
      During wakefulness, the EEG shows focal/multifocal spikes that increase in frequency during&#xD;
      the acute stage. During sleep, ESES appears and is characterized by (1) marked potentiation&#xD;
      of epileptiform discharges during non-REM sleep, leading to (2) a (near)-continuous,&#xD;
      bilateral, or occasionally lateralized slow spikes and waves, (3) and these spikes and waves&#xD;
      occur &quot;during a significant proportion&quot; of the non-REM sleep with a threshold ranging from&#xD;
      25% to 85%&#xD;
&#xD;
      The exact incidence of CSWS is not known. In pediatric neurology clinics, a reported&#xD;
      frequency of 0.2% of childhood epilepsies most probably underestimates the incidence of CSWS.&#xD;
&#xD;
      CSWS is a devastating syndrome, which requires prompt treatment, the efficacy of which is&#xD;
      checked with regular intervals, e.g. three or six months. Although epilepsy resolves with&#xD;
      time in most cases, many children are left with significant cognitive or language impairment.&#xD;
      Longer duration of ESES appears to be the major predictor of poor outcome.&#xD;
&#xD;
      So, early recognition and effective therapy are necessary to improve long-term prognosis in&#xD;
      this condition.&#xD;
&#xD;
      The goal of treatment is not only to control clinical seizures but also to improve&#xD;
      neuropsychological functions and prevent potential cognitive deterioration. There was no&#xD;
      agreement on best treatment, but potential candidates included high-dose benzodiazepines,&#xD;
      valproate, levetiracetam, and corticosteroids.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 2018</start_date>
  <completion_date type="Anticipated">October 2020</completion_date>
  <primary_completion_date type="Anticipated">October 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Cognitive ability</measure>
    <time_frame>IQ measured before treatment and after completing treatment course and then every three months for one year</time_frame>
    <description>Change in cognitive ability in response to steroids and benzodiazepines by IQ assessment using using Standford - Binnet scales version V.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Interictal epileptiform activity</measure>
    <time_frame>EEG will be done every three months for upto one year after discontinuation of therapy</time_frame>
    <description>epileptiform activity will be assessed by EEG recordings during sleep. The degree of epileptic activity during sleep will be measured and expressed as a spike wave index (SWI), which is defined as the total duration of continuous epileptic activity relative to total slow sleep duration.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in seizure frequency</measure>
    <time_frame>Measured before and one year after treatment</time_frame>
    <description>Compare the frequency of seizures before the start of treatment and after the start of treatment.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Epilepsy</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>corticosteroid</intervention_name>
    <description>Each patient will be subjected to a one month course of steroids and then re-evaluated</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Those patients who fulfill the inclusion criteria attending the neurology unit at Assiut&#xD;
        University Children Hospital will be administered the following treatment: 1. Nocturnal&#xD;
        diazepam for three months 2. Corticosteroids tapered over one months 3. Antiepileptic drug&#xD;
        other than sodium channel blockers which will be continued for at least two years. During&#xD;
        the course of the treatment the patients will be followed up by sleep EEG and IQ before and&#xD;
        at least one month after the start of treatment and regularly every three months for at&#xD;
        least one year after discontinuation of benzodiazepines and steroids.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All epileptic patients above 2 years of age presenting with neuropsychological&#xD;
             deterioration, seizures and ESES in NREM sleep. The degree of epileptic activity&#xD;
             during sleep will be measured and expressed as a spike wave index (SWI), which is&#xD;
             defined as the total duration of continuous epileptic activity relative to total slow&#xD;
             sleep duration. SWI must be at least 25% or more.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any epileptic patient not presenting with typical EEG findings and neurocognitive&#xD;
             regression.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>El - Sayed Kh Abdel - Karim</last_name>
    <phone>01060805170</phone>
    <email>khalilsay@gmail.com</email>
  </overall_contact>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>January 10, 2018</last_update_submitted>
  <last_update_submitted_qc>January 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Randa Abdelbadie Abdelaleem</investigator_full_name>
    <investigator_title>Assistant lecturer</investigator_title>
  </responsible_party>
  <keyword>electrical status epilepticus during slow wave sleep</keyword>
  <keyword>seizure</keyword>
  <keyword>cognition</keyword>
  <keyword>continuous spikes and waves during sleep</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Status Epilepticus</mesh_term>
  </condition_browse>
  <!-- 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/NCT03251820
org study id: MSESES
nct id: NCT03251820
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Electrical status epilepticus during slow wave sleep is a condition in which the epileptic
      patient starts to develop neurocognitive deterioration, any type of seizures and continuous
      electrical activity in the EEG during non rapid eye movement sleep. It is an age related
      condition and will resolve spontaneously at around the age of puberty. However if left
      untreated or treatment is delayed, it may lead to permanent neurocognitive deterioration.
      Thus early diagnosis and treatment is essential in these children to preserve neurocognitive
      function.
Electrical status epilepticus in sleep (ESES), also known as continuous spikes and waves
      during slow sleep (CSWS), is an age related, self - limiting disorder characterized by:

        1. epilepsy with different seizure types,

        2. neuropsychological regression, and

        3. typical EEG pattern of continuous epileptiform activity during non-rapid eye movement
           sleep (NREM).

      During wakefulness, the EEG shows focal/multifocal spikes that increase in frequency during
      the acute stage. During sleep, ESES appears and is characterized by (1) marked potentiation
      of epileptiform discharges during non-REM sleep, leading to (2) a (near)-continuous,
      bilateral, or occasionally lateralized slow spikes and waves, (3) and these spikes and waves
      occur "during a significant proportion" of the non-REM sleep with a threshold ranging from
      25% to 85%

      The exact incidence of CSWS is not known. In pediatric neurology clinics, a reported
      frequency of 0.2% of childhood epilepsies most probably underestimates the incidence of CSWS.

      CSWS is a devastating syndrome, which requires prompt treatment, the efficacy of which is
      checked with regular intervals, e.g. three or six months. Although epilepsy resolves with
      time in most cases, many children are left with significant cognitive or language impairment.
      Longer duration of ESES appears to be the major predictor of poor outcome.

      So, early recognition and effective therapy are necessary to improve long-term prognosis in
      this condition.

      The goal of treatment is not only to control clinical seizures but also to improve
      neuropsychological functions and prevent potential cognitive deterioration. There was no
      agreement on best treatment, but potential candidates included high-dose benzodiazepines,
      valproate, levetiracetam, and corticosteroids.
observational model: Cohort
time perspective: Prospective
measure: Cognitive ability
time frame: IQ measured before treatment and after completing treatment course and then every three months for one year
description: Change in cognitive ability in response to steroids and benzodiazepines by IQ assessment using using Standford - Binnet scales version V.
measure: Interictal epileptiform activity
time frame: EEG will be done every three months for upto one year after discontinuation of therapy
description: epileptiform activity will be assessed by EEG recordings during sleep. The degree of epileptic activity during sleep will be measured and expressed as a spike wave index (SWI), which is defined as the total duration of continuous epileptic activity relative to total slow sleep duration.
measure: Change in seizure frequency
time frame: Measured before and one year after treatment
description: Compare the frequency of seizures before the start of treatment and after the start of treatment.
intervention type: Drug
intervention name: corticosteroid
description: Each patient will be subjected to a one month course of steroids and then re-evaluated
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 2 Years
maximum age: 18 Years
healthy volunteers: No
last name: El - Sayed Kh Abdel - Karim
phone: 01060805170
email: khalilsay@gmail.com
responsible party type: Sponsor-Investigator
investigator affiliation: Assiut University
investigator full name: Randa Abdelbadie Abdelaleem
investigator title: Assistant lecturer
mesh term: Status Epilepticus