<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/NCT02976545</url>
  </required_header>
  <id_info>
    <org_study_id>2016-A01295-46</org_study_id>
    <nct_id>NCT02976545</nct_id>
  </id_info>
  <brief_title>Emotional Lived in Patients Suffering From Psychogenic Nonepileptic Seizures : Study by Functional Magnetic Resonance Imaging</brief_title>
  <acronym>EMOCRISES</acronym>
  <official_title>VECU EMOTIONNEL CHEZ LES PATIENTES SOUFFRANT DE CRISES NON EPILEPTIQUES PSYCHOGENES : ETUDE EN IMAGERIE PAR RESONANCE MAGNETIQUE FONCTIONNELLE-ETUDE EMOCRISES</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Central Hospital, Nancy, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Central Hospital, Nancy, France</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Currently, hypothetical models of understanding Psychogenic Non-epileptic Seizures (PNES)&#xD;
      involve emotional dysregulation.&#xD;
&#xD;
      The hypothesis of a disorder of emotional experience is mainly based on behavioral data and&#xD;
      disturbance of autonomic responses in response to images in emotional content (Mignot et al&#xD;
      2015, in submission; Bakvis et al 2013). Various imaging studies have identified brain&#xD;
      structures belonging to the limbic system in particular that seem functionally impaired in&#xD;
      this population. These functional connectivity abnormalities are correlated with dissociation&#xD;
      scores in PNES patients (Van der Kruijs et al 2012 and 2014).&#xD;
&#xD;
      Investigators propose to specifically study the brain activity of PNES patients during tasks&#xD;
      emotional content to identify the mechanisms involved in this emotional dysregulation. This&#xD;
      work is essential to understanding the mechanisms and the development of new therapeutic&#xD;
      strategies&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 3, 2017</start_date>
  <completion_date type="Anticipated">April 2023</completion_date>
  <primary_completion_date type="Anticipated">April 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Brain activity</measure>
    <time_frame>6 months after the last inclusion</time_frame>
    <description>To compare brain activity during emotional tasks in fMRI (Blood-Oxygen-Level-Dependent contrast sequences) between: patients suffering from PNES, patients suffering from PTSD and healthy controls, with age and education level matching.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Valence and intensity of the emotional images</measure>
    <time_frame>6 months after the last inclusion</time_frame>
    <description>To compare subjective experience rating across the three groups, during emotional pictures watching task;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cerebral functional connectivity</measure>
    <time_frame>6 months after the last inclusion</time_frame>
    <description>To compare differences of cerebral functional connectivity (main physiological brain networks) in resting state fMRI across the tree groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>&quot;Dissociative Experience Scale (DES) questionnaire&quot; score and &quot;Toronto Alexithymia Scale (TAS20) questionnaire&quot; score</measure>
    <time_frame>6 months after the last inclusion</time_frame>
    <description>To study the correlation between cerebral activity and level of dissociation (DES) and alexithymia (TAS20) in PNES and PTSD groups</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">75</enrollment>
  <condition>Psychogenic Non-epileptic Seizures</condition>
  <arm_group>
    <arm_group_label>PNES</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Psychogenic Non-epileptic Seizures subjects</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PTSD</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Post Traumatic Stress Disorder</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy controls</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Healthy controls</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>fMRI (functional Magnetic Resonance Imaging)</intervention_name>
    <description>fMRI examination</description>
    <arm_group_label>Healthy controls</arm_group_label>
    <arm_group_label>PNES</arm_group_label>
    <arm_group_label>PTSD</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>psychiatric evaluation</intervention_name>
    <description>psychiatric evaluation</description>
    <arm_group_label>Healthy controls</arm_group_label>
    <arm_group_label>PNES</arm_group_label>
    <arm_group_label>PTSD</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Common Inclusion Criteria:&#xD;
&#xD;
          -  Female,&#xD;
&#xD;
          -  Right-handed&#xD;
&#xD;
          -  Affiliation to the French social security system,&#xD;
&#xD;
          -  Informed signing of the study consent.&#xD;
&#xD;
        Specific Inclusion Criteria for PNES group :&#xD;
&#xD;
          -  PNES diagnosed by a neurologist specialized in epilepsy, based on clinical symptoms&#xD;
             analysis and video-EEG recording,&#xD;
&#xD;
          -  Absence of concomitant epilepsy.&#xD;
&#xD;
        Specific Inclusion Criteria for PTSD group : PTSD diagnosed by a psychiatrist, based on&#xD;
        clinical symptoms as recorded in DSM5 (Diagnostic and Statistical Manual of Mental&#xD;
        Disorders).&#xD;
&#xD;
        Specific Inclusion Criteria for healthy controls : Healthy controls will be paired up with&#xD;
        patients on age and level of schooling criteria.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        common criteria for all groups:&#xD;
&#xD;
          -  Neurological history or comorbidity (epilepsy included),&#xD;
&#xD;
          -  Current neurological treatment,&#xD;
&#xD;
          -  Posology change or introduction of psychoactive treatment dating back to less than a&#xD;
             month,&#xD;
&#xD;
          -  Psychotic comorbidity (schizophrenia),&#xD;
&#xD;
          -  Addiction history apart for smoking,&#xD;
&#xD;
          -  History of head trauma,&#xD;
&#xD;
          -  Mental retardation,&#xD;
&#xD;
          -  Being the subject of articles L.1121-5 to L.1121-8 and L1122-1-2 of the French Code of&#xD;
             Public Health (i.e. being a not responsible adult),&#xD;
&#xD;
          -  Lack of French language proficiency or inability to understand instructions,&#xD;
&#xD;
          -  Uncorrected visual impairment,&#xD;
&#xD;
          -  Any contraindication to MRI (pacemaker, ferromagnetic foreign body, claustrophobia,&#xD;
             etc.).&#xD;
&#xD;
        Specific exclusion Criteria for PNES group : Diagnosis of PNES challenged or denied by the&#xD;
        patient.&#xD;
&#xD;
        Specific exclusion Criteria for PTSD group :&#xD;
&#xD;
          -  Diagnosis of PTSD challenged or denied by the patient, current or history of&#xD;
             functional neurological symptom disorder,&#xD;
&#xD;
          -  History of PNES (conversion disorder).&#xD;
&#xD;
        Specific exclusion Criteria for healthy controls :&#xD;
&#xD;
          -  History of PTSD,&#xD;
&#xD;
          -  History of PNES (conversion disorder).&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Coraline Hingray, MD</last_name>
    <phone>33383926260</phone>
    <email>c.hingray@chru-nancy.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Gabriela Hossu, PhD</last_name>
    <phone>33383155096</phone>
    <email>g.hossu@chru-nancy.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CHRU de Nancy</name>
      <address>
        <city>Nancy</city>
        <zip>54000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Coraline Hingray, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>November 25, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>June 10, 2021</last_update_submitted>
  <last_update_submitted_qc>June 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Central Hospital, Nancy, France</investigator_affiliation>
    <investigator_full_name>M.D. Coraline HINGRAY</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Seizures</mesh_term>
    <mesh_term>Psychogenic Nonepileptic Seizures</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/NCT02976545
org study id: 2016-A01295-46
nct id: NCT02976545
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Currently, hypothetical models of understanding Psychogenic Non-epileptic Seizures (PNES)
      involve emotional dysregulation.

      The hypothesis of a disorder of emotional experience is mainly based on behavioral data and
      disturbance of autonomic responses in response to images in emotional content (Mignot et al
      2015, in submission; Bakvis et al 2013). Various imaging studies have identified brain
      structures belonging to the limbic system in particular that seem functionally impaired in
      this population. These functional connectivity abnormalities are correlated with dissociation
      scores in PNES patients (Van der Kruijs et al 2012 and 2014).

      Investigators propose to specifically study the brain activity of PNES patients during tasks
      emotional content to identify the mechanisms involved in this emotional dysregulation. This
      work is essential to understanding the mechanisms and the development of new therapeutic
      strategies
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Brain activity
time frame: 6 months after the last inclusion
description: To compare brain activity during emotional tasks in fMRI (Blood-Oxygen-Level-Dependent contrast sequences) between: patients suffering from PNES, patients suffering from PTSD and healthy controls, with age and education level matching.
measure: Valence and intensity of the emotional images
time frame: 6 months after the last inclusion
description: To compare subjective experience rating across the three groups, during emotional pictures watching task;
measure: Cerebral functional connectivity
time frame: 6 months after the last inclusion
description: To compare differences of cerebral functional connectivity (main physiological brain networks) in resting state fMRI across the tree groups
measure: "Dissociative Experience Scale (DES) questionnaire" score and "Toronto Alexithymia Scale (TAS20) questionnaire" score
time frame: 6 months after the last inclusion
description: To study the correlation between cerebral activity and level of dissociation (DES) and alexithymia (TAS20) in PNES and PTSD groups
arm group label: PNES
arm group type: Other
description: Psychogenic Non-epileptic Seizures subjects
arm group label: PTSD
arm group type: Other
description: Post Traumatic Stress Disorder
arm group label: Healthy controls
arm group type: Other
description: Healthy controls
intervention type: Device
intervention name: fMRI (functional Magnetic Resonance Imaging)
description: fMRI examination
arm group label: Healthy controls
arm group label: PNES
arm group label: PTSD
intervention type: Behavioral
intervention name: psychiatric evaluation
description: psychiatric evaluation
arm group label: Healthy controls
arm group label: PNES
arm group label: PTSD
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Coraline Hingray, MD
phone: 33383926260
email: c.hingray@chru-nancy.fr
last name: Gabriela Hossu, PhD
phone: 33383155096
email: g.hossu@chru-nancy.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Central Hospital, Nancy, France
investigator full name: M.D. Coraline HINGRAY
investigator title: Doctor
mesh term: Seizures
mesh term: Psychogenic Nonepileptic Seizures