xml: <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/NCT05968313</url>
    </required_header>
    <id_info>
      <org_study_id>BAM_lab_NSSI_02</org_study_id>
      <nct_id>NCT05968313</nct_id>
    </id_info>
    <brief_title>Altered Neural Pain Empathic Reactivity in NSSI Adolescents</brief_title>
    <official_title>Abnormal Neural Pain Empathic Processing in Adolescents With Non-suicidal Self-Injury</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Electronic Science and Technology of China</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Electronic Science and Technology of China</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Nonsuicidal self-injury (NSSI) is defined as direct, deliberate bodily harm without suicidal&#xD;
        intention. In recent years, growing evidence suggests that NSSI has become a worldwide public&#xD;
        health issue. People with NSSI behaviors, especially adolescents, commonly exhibit&#xD;
        emotion-related and interpersonal problems. Pain empathy represents an essential basal domain&#xD;
        of socio-emotional processing and refers to the ability to empathize, connect and share with&#xD;
        others' pain. However, altered empathic processing has not been systematically examined in&#xD;
        adolescents with NSSI. To this end, the current functional magnetic resonance imaging (fMRI)&#xD;
        study will recruit one group of NSSI adolescents (n=40) and one healthy control (HC) group&#xD;
        (n=40), to compare their neural activity regarding pain empathy processing, which is measured&#xD;
        by blood oxygenation level-dependent (BOLD) fMRI. The investigators included conditions of&#xD;
        physical pain empathy (stimuli depicting noxious stimulation to the limbs) and affective pain&#xD;
        empathy (stimuli depicting faces expressing pain) as well as corresponding control stimuli.&#xD;
        The investigators hypothesize that compared to HC, NSSI adolescents show increased empathic&#xD;
        reactivity to physical pain stimuli in salience and arousal related brain regions but&#xD;
        decreased empathic reactivity to affective pain empathic stimuli.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">July 2023</start_date>
    <completion_date type="Anticipated">July 2027</completion_date>
    <primary_completion_date type="Anticipated">July 2026</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Neural activity as indexed by BOLD fMRI</measure>
      <time_frame>About 8 minutes</time_frame>
      <description>Brain activity will be monitored by task-based fMRI. The paradigm will present affective and physical pain empathy pictures and matched control stimuli. Alterations in the patients will be determined by comparing neural activity to the experimental conditions between the experimental groups (NSSI vs. HC) using ANOVA models.</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Nonsuicidal Self Injury</condition>
    <condition>Pain Empathy</condition>
    <arm_group>
      <arm_group_label>NSSI</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>HC</arm_group_label>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Treatment-seeking NSSI individuals will be recruited from local hospitals and HC from the&#xD;
          community&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  15-18 years&#xD;
  &#xD;
            -  right-handed&#xD;
  &#xD;
            -  normal or corrected normal visual acuity&#xD;
  &#xD;
            -  meet the proposed DSM-5 frequency criteria (e.g., ≥5 days of NSSI behaviors in the&#xD;
               past year)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  diagnosis of borderline personality disorder, major depressive disorder, other&#xD;
  &#xD;
            -  psychiatric disorders, etc.&#xD;
  &#xD;
            -  high suicidal risk&#xD;
  &#xD;
            -  recent use of medications that can affect neural activity&#xD;
  &#xD;
            -  have received or are receiving Dialectical Behavior Therapy (DBT) other treatment for&#xD;
               emotional problems within the past 6 months&#xD;
  &#xD;
            -  have a contraindication to MRI scanning (e.g., metal implants, claustrophobia or other&#xD;
               conditions that make them inappropriate for MRI scanning)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>15 Years</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Benjamin Becker</last_name>
      <phone>+86.028-61830867</phone>
      <email>ben_becker@gmx.de</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 30, 2023</last_update_submitted>
    <last_update_submitted_qc>July 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Electronic Science and Technology of China</investigator_affiliation>
      <investigator_full_name>Benjamin Becker</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Self-Injurious Behavior</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05968313
  org study id: BAM_lab_NSSI_02
  nct id: NCT05968313
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Nonsuicidal self-injury (NSSI) is defined as direct, deliberate bodily harm without suicidal
        intention. In recent years, growing evidence suggests that NSSI has become a worldwide public
        health issue. People with NSSI behaviors, especially adolescents, commonly exhibit
        emotion-related and interpersonal problems. Pain empathy represents an essential basal domain
        of socio-emotional processing and refers to the ability to empathize, connect and share with
        others' pain. However, altered empathic processing has not been systematically examined in
        adolescents with NSSI. To this end, the current functional magnetic resonance imaging (fMRI)
        study will recruit one group of NSSI adolescents (n=40) and one healthy control (HC) group
        (n=40), to compare their neural activity regarding pain empathy processing, which is measured
        by blood oxygenation level-dependent (BOLD) fMRI. The investigators included conditions of
        physical pain empathy (stimuli depicting noxious stimulation to the limbs) and affective pain
        empathy (stimuli depicting faces expressing pain) as well as corresponding control stimuli.
        The investigators hypothesize that compared to HC, NSSI adolescents show increased empathic
        reactivity to physical pain stimuli in salience and arousal related brain regions but
        decreased empathic reactivity to affective pain empathic stimuli.
  observational model: Case-Control
  time perspective: Cross-Sectional
  measure: Neural activity as indexed by BOLD fMRI
  time frame: About 8 minutes
  description: Brain activity will be monitored by task-based fMRI. The paradigm will present affective and physical pain empathy pictures and matched control stimuli. Alterations in the patients will be determined by comparing neural activity to the experimental conditions between the experimental groups (NSSI vs. HC) using ANOVA models.
  arm group label: NSSI
  arm group label: HC
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 15 Years
  maximum age: 18 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Benjamin Becker
  phone: +86.028-61830867
  email: ben_becker@gmx.de
  responsible party type: Principal Investigator
  investigator affiliation: University of Electronic Science and Technology of China
  investigator full name: Benjamin Becker
  investigator title: Professor
  mesh term: Self-Injurious Behavior