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/NCT06033053</url>
    </required_header>
    <id_info>
      <org_study_id>BAM_lab_MOST_05</org_study_id>
      <nct_id>NCT06033053</nct_id>
    </id_info>
    <brief_title>Real-time Neurofeedback Training of Fronto-limbic Regions Functional Connectivity</brief_title>
    <official_title>Real-time Neurofeedback Training of Fronto-limbic Areas Functional Connectivity to Reduce Arousal</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>
      <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>
        This is randomized active-sham group controlled between-subject real-time fMRI neurofeedback&#xD;
        trial aimed at modulating the ventromedial prefrontal cortex (vmPFC)-amygdala pathway to&#xD;
        control subjective anxiety and arousal.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The present randomized active-sham group controlled between-subject real-time fMRI&#xD;
        neurofeedback trial aims at determining if (1) subjects can gain volitional control over the&#xD;
        vmPFC-amygdala pathway involved in implicit emotion regulation and arousal by means of&#xD;
        connectivity informed neurofeedback, (2) whether the training has specific effects on the&#xD;
        behavioral and psychophysiological arousal level, and (3) or the amygdala or the vmPFC&#xD;
        connectivity, respectively.&#xD;
  &#xD;
        The present project will determine the efficacy of the modulation of the vmPFC-amygdala&#xD;
        functional connectivity pathway using vmPFC-amygdala upregulation (n = 25 subjects) compared&#xD;
        to a sham control condition (targeting pathways not involved in emotion regulation, n = 20).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">March 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Randomized active-sham group controlled between-subject: Group of healthy individuals will be randomly assigned to the experimental or the sham condition. The experimental group, will learn how to modulate the vmPFC-amygdala functional connectivity, while the sham group will try to modulate the functional connectivity of sham regions not involved in emotion regulation.</intervention_model_description>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
      <masking_description>The recruiter and the person in charge of conducting the experiment will be blind to the experimental condition, as will the participants.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Functional connectivity computed from blood oxygenation level dependent (BOLD) functional magnetic resonance imaging between regions of interest.</measure>
      <time_frame>40 min</time_frame>
      <description>Increased functional connectivity computed from BOLD fMRI over the course of the real-time NF-fMRI training sessions in the neurofeedback group (regions of interest: bilateral amygdala and prefrontal area) but not in the sham group (regions of interest: bilateral motor cortex and primary auditory areas). Functional connectivity strength will be represented by bivariate regression coefficients from a general linear model characterizing the association between their BOLD signal timeseries</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Level of behavioural arousal assessed on NRS from 0 to 10</measure>
      <time_frame>10 min</time_frame>
      <description>After the presentation of movie clips inducing strong fearful emotions, the participant will rate the behavioural level of arousal on a Numeric Rating Scale (NRS) from 0 (lowest level of arousal) to 10 (highest level of arousal). The neurofeedback group will present lower level of arousal in comparison to the sham group.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Level of behavioural anxiety assessed on NRS from 0 to 10</measure>
      <time_frame>10 min</time_frame>
      <description>After the presentation of movie clips inducing strong fearful emotions, the participant will rate the behavioural level of anxiety on a Numeric Rating Scale (NRS) from 0 (lowest level of anxiety) to 10 (highest level of anxiety). The neurofeedback group will present lower level of anxiety in comparison to the sham group.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">45</enrollment>
    <condition>Emotion Regulation</condition>
    <condition>Healthy</condition>
    <arm_group>
      <arm_group_label>Experimental</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The experimental group will learn how to modulate the vmPFC-amygdala functional connectivity while being presented with pictures inducing fear.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sham</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>The sham group will learn how to modulate the functional connectivity of sham ROIs while being presented with pictures inducing fear.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Real-time fMRI neurofeedback from Turbo Brain voyager (TBV) 3.2</intervention_name>
      <description>The two groups will undergo the same paradigm while learning to modulate the vmPFC -amygdala pathway and the sham pathway.</description>
      <arm_group_label>Experimental</arm_group_label>
      <arm_group_label>Sham</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  age &gt; 18 years old&#xD;
  &#xD;
            -  other genders&#xD;
  &#xD;
            -  No past or current psychiatric or neurological or other main disorders.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnant, taking oral contraceptives&#xD;
  &#xD;
            -  Current use of medications&#xD;
  &#xD;
            -  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>18 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Benjamin Becker, Ph.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Electronic Science and Technology of China</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Benjamin Becker, Ph.D.</last_name>
      <phone>+86-28-61830670</phone>
      <email>ben_becker@gmx.de</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Stefania Ferraro, Ph.D.</last_name>
      <phone>+18684009672</phone>
      <email>stefania@uestc.edu.cn</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of Electronic Science and Technology of China</name>
        <address>
          <city>Chengdu</city>
          <state>Sichuan</state>
          <zip>611731</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Stefania Ferraro, PhD</last_name>
        <phone>18684009672</phone>
        <email>stefania@uestc.edu.cn</email>
      </contact>
      <contact_backup>
        <email>stefania@uestc.edu.cn</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 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>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06033053
  org study id: BAM_lab_MOST_05
  nct id: NCT06033053
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is randomized active-sham group controlled between-subject real-time fMRI neurofeedback
        trial aimed at modulating the ventromedial prefrontal cortex (vmPFC)-amygdala pathway to
        control subjective anxiety and arousal.
  The present randomized active-sham group controlled between-subject real-time fMRI
        neurofeedback trial aims at determining if (1) subjects can gain volitional control over the
        vmPFC-amygdala pathway involved in implicit emotion regulation and arousal by means of
        connectivity informed neurofeedback, (2) whether the training has specific effects on the
        behavioral and psychophysiological arousal level, and (3) or the amygdala or the vmPFC
        connectivity, respectively.
  
        The present project will determine the efficacy of the modulation of the vmPFC-amygdala
        functional connectivity pathway using vmPFC-amygdala upregulation (n = 25 subjects) compared
        to a sham control condition (targeting pathways not involved in emotion regulation, n = 20).
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomized active-sham group controlled between-subject: Group of healthy individuals will be randomly assigned to the experimental or the sham condition. The experimental group, will learn how to modulate the vmPFC-amygdala functional connectivity, while the sham group will try to modulate the functional connectivity of sham regions not involved in emotion regulation.
  primary purpose: Basic Science
  masking: Double (Participant, Investigator)
  masking description: The recruiter and the person in charge of conducting the experiment will be blind to the experimental condition, as will the participants.
  measure: Functional connectivity computed from blood oxygenation level dependent (BOLD) functional magnetic resonance imaging between regions of interest.
  time frame: 40 min
  description: Increased functional connectivity computed from BOLD fMRI over the course of the real-time NF-fMRI training sessions in the neurofeedback group (regions of interest: bilateral amygdala and prefrontal area) but not in the sham group (regions of interest: bilateral motor cortex and primary auditory areas). Functional connectivity strength will be represented by bivariate regression coefficients from a general linear model characterizing the association between their BOLD signal timeseries
  measure: Level of behavioural arousal assessed on NRS from 0 to 10
  time frame: 10 min
  description: After the presentation of movie clips inducing strong fearful emotions, the participant will rate the behavioural level of arousal on a Numeric Rating Scale (NRS) from 0 (lowest level of arousal) to 10 (highest level of arousal). The neurofeedback group will present lower level of arousal in comparison to the sham group.
  measure: Level of behavioural anxiety assessed on NRS from 0 to 10
  time frame: 10 min
  description: After the presentation of movie clips inducing strong fearful emotions, the participant will rate the behavioural level of anxiety on a Numeric Rating Scale (NRS) from 0 (lowest level of anxiety) to 10 (highest level of anxiety). The neurofeedback group will present lower level of anxiety in comparison to the sham group.
  arm group label: Experimental
  arm group type: Experimental
  description: The experimental group will learn how to modulate the vmPFC-amygdala functional connectivity while being presented with pictures inducing fear.
  arm group label: Sham
  arm group type: Sham Comparator
  description: The sham group will learn how to modulate the functional connectivity of sham ROIs while being presented with pictures inducing fear.
  intervention type: Device
  intervention name: Real-time fMRI neurofeedback from Turbo Brain voyager (TBV) 3.2
  description: The two groups will undergo the same paradigm while learning to modulate the vmPFC -amygdala pathway and the sham pathway.
  arm group label: Experimental
  arm group label: Sham
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Benjamin Becker, Ph.D.
  role: Principal Investigator
  affiliation: University of Electronic Science and Technology of China
  last name: Benjamin Becker, Ph.D.
  phone: +86-28-61830670
  email: ben_becker@gmx.de
  last name: Stefania Ferraro, Ph.D.
  phone: +18684009672
  email: stefania@uestc.edu.cn
  facility: 
  contact: 
  contact backup: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: University of Electronic Science and Technology of China
  investigator full name: Benjamin Becker
  investigator title: Professor
  sharing ipd: No