<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/NCT03035513</url>
  </required_header>
  <id_info>
    <org_study_id>CHU-0299</org_study_id>
    <secondary_id>2016-A01149-42</secondary_id>
    <nct_id>NCT03035513</nct_id>
  </id_info>
  <brief_title>Diffusion Tensor Imaging in Epilepsy With Continuous Spikes and Waves During Sleep</brief_title>
  <acronym>POCS-DTI</acronym>
  <official_title>Diffusion Tensor Imaging of the Thalamo-cortical Network in Epilepsy With Continuous Spikes and Waves During Sleep</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Clermont-Ferrand</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Clermont-Ferrand</source>
  <brief_summary>
    <textblock>
      Continuous Spikes and Waves during Sleep (CSWS) is a rare paediatric epileptic&#xD;
      encephalopathy. Even if the correlation between the severity of the epilepsy and the&#xD;
      cognitive consequences is well established, the mechanisms involved in epileptic cognitive&#xD;
      degradation are complex and poorly understood. In CSWS, there are many arguments for the&#xD;
      implication of cortical and subcortical cerebral structures. Among them the thalamus seems to&#xD;
      play a crucial role. In fact it is strongly implicated in the sleep and this function is&#xD;
      determining for learning. Moreover, it is part of the propagation pathway of generalized&#xD;
      forms of epilepsy like absences in animal studies. Unfortunately there is no animal model for&#xD;
      CSWS to confirm this theory. In human studies, few cases are caused by thalamic injuries but&#xD;
      most of the time conventional MRI is normal. Despite few literature on CSWS, some studies&#xD;
      reported abnormal functional connectivity especially in the thalamus.&#xD;
&#xD;
      The investigators hypothesize that the first utilisation of diffusion tensor imaging (DTI)&#xD;
      and tractography will be useful in CSWS to confirm the implication of a&#xD;
      cortico-thalamo-cortical network showing an abnormal structural connectivity. The&#xD;
      investigators will try to determinate if a particular thalamic nucleus is concerned and&#xD;
      demonstrate a link between the disease severity (duration and cognitive consequences) and the&#xD;
      importance of structural abnormalities.&#xD;
&#xD;
      Using resting state functional MRI (fMRI), the investigators will also try to investigate the&#xD;
      default mode network. Its implication was also suggested in the literature.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Continuous Spikes and Waves during Sleep (CSWS) is a rare paediatric epileptic&#xD;
      encephalopathy. Even if the correlation between the severity of the epilepsy and the&#xD;
      cognitive consequences is well established, the mechanisms involved in epileptic cognitive&#xD;
      degradation are complex and poorly understood. In CSWS, there are many arguments for the&#xD;
      implication of cortical and subcortical cerebral structures. Among them the thalamus seems to&#xD;
      play a crucial role. In fact it is strongly implicated in the sleep and this function is&#xD;
      determining for learning. Moreover, it is part of the propagation pathway of generalized&#xD;
      forms of epilepsy like absences in animal studies. Unfortunately there is no animal model for&#xD;
      CSWS to confirm this theory. In human studies, few cases are caused by thalamic injuries but&#xD;
      most of the time conventional MRI is normal. Despite few literature on CSWS, some studies&#xD;
      reported abnormal functional connectivity especially in the thalamus.&#xD;
&#xD;
      The investigators hypothesize that the first utilisation of diffusion tensor imaging (DTI)&#xD;
      and tractography will be useful in CSWS to confirm the implication of a&#xD;
      cortico-thalamo-cortical network showing an abnormal structural connectivity. The&#xD;
      investigators will try to determinate if a particular thalamic nucleus is concerned and&#xD;
      demonstrate a link between the disease severity (duration and cognitive consequences) and the&#xD;
      importance of structural abnormalities.&#xD;
&#xD;
      Using resting state functional MRI (fMRI), the investigators will also try to investigate the&#xD;
      default mode network. Its implication was also suggested in the literature.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">February 2020</completion_date>
  <primary_completion_date type="Anticipated">February 2020</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Structural connectivity of the thalamo-cortical network</measure>
    <time_frame>at day 1</time_frame>
    <description>Structural connectivity of the thalamo-cortical network will be assessed using DTI fractional anisotropy.&#xD;
The data of CSWS patients will be statistically compared to healthy volunteers</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Some comparisons with electrophysiological and neuropsychological data will be done</measure>
    <time_frame>at day 1</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">45</enrollment>
  <condition>Cryptogenic Epilepsy</condition>
  <arm_group>
    <arm_group_label>CSWS patients</arm_group_label>
    <description>The data of CSWS patients will be statistically compared to healthy volunteers</description>
  </arm_group>
  <arm_group>
    <arm_group_label>healthy volunteers</arm_group_label>
    <description>The data of CSWS patients will be statistically compared to healthy volunteers</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Continuous spikes and waves during slow sleep (CSWS)</intervention_name>
    <arm_group_label>CSWS patients</arm_group_label>
    <arm_group_label>healthy volunteers</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients, diagnosis of CSWS according to the current diagnostic criteria (ILAE 2001)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  - for the patients, diagnosis of CSWS according to the current diagnostic criteria&#xD;
             (ILAE 2001)&#xD;
&#xD;
          -  minimal age of 5 years old&#xD;
&#xD;
          -  written consent to participate in the study from the subjects who could write and/or&#xD;
             from the parents or legal representative&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  rejection of the patient or its legal representative&#xD;
&#xD;
          -  no respect of inclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dominique ROSENBERG</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Clermont-Ferrand</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Patrick LACARIN</last_name>
    <phone>0473751195</phone>
    <email>placarin@chu-clermontferrand.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU Clermont-Ferrand</name>
      <address>
        <city>Clermont-ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Patrick LACARIN</last_name>
      <phone>0473751195</phone>
      <email>placarin@chu-clermontferrand.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 13, 2017</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>January 27, 2017</last_update_submitted>
  <last_update_submitted_qc>January 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Continuous spikes</keyword>
  <keyword>Epilepsy</keyword>
  <keyword>Nervous system disease</keyword>
  <keyword>Neuronal plasticity</keyword>
  <keyword>Diffusion MRI</keyword>
  <keyword>Functional MRI</keyword>
  <keyword>waves during slow sleep (CSWS)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epilepsy</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/NCT03035513
org study id: CHU-0299
secondary id: 2016-A01149-42
nct id: NCT03035513
lead sponsor: 
Continuous Spikes and Waves during Sleep (CSWS) is a rare paediatric epileptic
      encephalopathy. Even if the correlation between the severity of the epilepsy and the
      cognitive consequences is well established, the mechanisms involved in epileptic cognitive
      degradation are complex and poorly understood. In CSWS, there are many arguments for the
      implication of cortical and subcortical cerebral structures. Among them the thalamus seems to
      play a crucial role. In fact it is strongly implicated in the sleep and this function is
      determining for learning. Moreover, it is part of the propagation pathway of generalized
      forms of epilepsy like absences in animal studies. Unfortunately there is no animal model for
      CSWS to confirm this theory. In human studies, few cases are caused by thalamic injuries but
      most of the time conventional MRI is normal. Despite few literature on CSWS, some studies
      reported abnormal functional connectivity especially in the thalamus.

      The investigators hypothesize that the first utilisation of diffusion tensor imaging (DTI)
      and tractography will be useful in CSWS to confirm the implication of a
      cortico-thalamo-cortical network showing an abnormal structural connectivity. The
      investigators will try to determinate if a particular thalamic nucleus is concerned and
      demonstrate a link between the disease severity (duration and cognitive consequences) and the
      importance of structural abnormalities.

      Using resting state functional MRI (fMRI), the investigators will also try to investigate the
      default mode network. Its implication was also suggested in the literature.
Continuous Spikes and Waves during Sleep (CSWS) is a rare paediatric epileptic
      encephalopathy. Even if the correlation between the severity of the epilepsy and the
      cognitive consequences is well established, the mechanisms involved in epileptic cognitive
      degradation are complex and poorly understood. In CSWS, there are many arguments for the
      implication of cortical and subcortical cerebral structures. Among them the thalamus seems to
      play a crucial role. In fact it is strongly implicated in the sleep and this function is
      determining for learning. Moreover, it is part of the propagation pathway of generalized
      forms of epilepsy like absences in animal studies. Unfortunately there is no animal model for
      CSWS to confirm this theory. In human studies, few cases are caused by thalamic injuries but
      most of the time conventional MRI is normal. Despite few literature on CSWS, some studies
      reported abnormal functional connectivity especially in the thalamus.

      The investigators hypothesize that the first utilisation of diffusion tensor imaging (DTI)
      and tractography will be useful in CSWS to confirm the implication of a
      cortico-thalamo-cortical network showing an abnormal structural connectivity. The
      investigators will try to determinate if a particular thalamic nucleus is concerned and
      demonstrate a link between the disease severity (duration and cognitive consequences) and the
      importance of structural abnormalities.

      Using resting state functional MRI (fMRI), the investigators will also try to investigate the
      default mode network. Its implication was also suggested in the literature.
observational model: Other
time perspective: Cross-Sectional
measure: Structural connectivity of the thalamo-cortical network
time frame: at day 1
description: Structural connectivity of the thalamo-cortical network will be assessed using DTI fractional anisotropy.
The data of CSWS patients will be statistically compared to healthy volunteers
measure: Some comparisons with electrophysiological and neuropsychological data will be done
time frame: at day 1
arm group label: CSWS patients
description: The data of CSWS patients will be statistically compared to healthy volunteers
arm group label: healthy volunteers
description: The data of CSWS patients will be statistically compared to healthy volunteers
intervention type: Other
intervention name: Continuous spikes and waves during slow sleep (CSWS)
arm group label: CSWS patients
arm group label: healthy volunteers
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 5 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dominique ROSENBERG
role: Principal Investigator
affiliation: University Hospital, Clermont-Ferrand
last name: Patrick LACARIN
phone: 0473751195
email: placarin@chu-clermontferrand.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Epilepsy