<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/NCT02194907</url>
  </required_header>
  <id_info>
    <org_study_id>IRB201300814 closed</org_study_id>
    <nct_id>NCT02194907</nct_id>
  </id_info>
  <brief_title>Emotion Study -- A Neurofeedback Approach</brief_title>
  <official_title>Emotion Study -- Improving Neural Dysregulation in Advanced Age: A Neurofeedback Approach</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Florida</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 study will determine whether brain activity can be modified and improves performance on&#xD;
      a task by showing participants live 'video feed' of their brains on advanced imaging&#xD;
      technology. The study is particularly interested in brain regions that have been shown to be&#xD;
      relevant for emotions, specifically the anterior insula and the medial prefrontal cortex.&#xD;
      Advanced technology will map the brain using magnetic pulses with a real-time functional&#xD;
      Magnetic Resonance Imaging (rt-fMRI) machine.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Overview: All participants of both age groups will be randomly divided (like tossing a coin)&#xD;
      into two groups:&#xD;
&#xD;
        -  One group will have training sessions using a special feedback technique to learn to&#xD;
           actively increase blood flow in the front of the brain, while thinking of and viewing&#xD;
           emotional faces, scenes, and text&#xD;
&#xD;
        -  The other group will have training sessions using a special feedback technique to learn&#xD;
           to actively increase blood flow in the back of the brain while thinking of and viewing&#xD;
           emotional faces, scenes, and text&#xD;
&#xD;
      Further, each of these two groups will be divided into two sub-groups that are different with&#xD;
      respect to the training procedure that is used:&#xD;
&#xD;
      * Use of a 3.0 Tesla, 32-channel Seimens whole-body human MR scanner (fMRI) during training,&#xD;
      that has not been associated with any known side effects or safety risks&#xD;
&#xD;
      Number of Study Visits:&#xD;
&#xD;
      This study has the following parts: A pre-training visit, six training visits, and a&#xD;
      post-training visit.&#xD;
&#xD;
      With a few exceptions as explained below, the procedures during pre-training, training, and&#xD;
      post-training visits are identical.&#xD;
&#xD;
        -  At the beginning of the first visit, the investigator will tell the participant about&#xD;
           the study and what is involved and will ask them to sign a consent form. The participant&#xD;
           may ask as many questions as they would like before deciding about study participation.&#xD;
&#xD;
        -  For each of the visits, the investigator will review questions with the participant&#xD;
           about their health to ensure their eligibility to undergo fMRI on the day of testing.&#xD;
&#xD;
        -  Also for each visit, the investigator will ask the participant to respond to a short&#xD;
           questionnaire related to their current mood.&#xD;
&#xD;
        -  In the pre-training and the post-training visits only, the investigator will ask the&#xD;
           participant to answer questions about their feelings, emotions, and thoughts.&#xD;
&#xD;
        -  For each of the participant's visits, they will spend 50-60 minutes either in the MRI&#xD;
           scanner, while viewing pictures and text on a screen. During this time, pictures of the&#xD;
           participant's brain at work and at rest will be acquired. In the training visits only,&#xD;
           the participant will learn to increase blood flow in certain brain regions with the help&#xD;
           of information presented to them on the screen.&#xD;
&#xD;
        -  For each of the participant's visits, they will be asked to respond to a short&#xD;
           questionnaire related to their current mood.&#xD;
&#xD;
        -  In the pre-training/post-training visits only, the investigator will ask the participant&#xD;
           to answer questions about their feelings, emotions, and thoughts as well as their&#xD;
           personality. The participant will also perform brief tests related to the thinking&#xD;
           process.&#xD;
&#xD;
        -  At the end of each visit, the participant will complete a questionnaire about how they&#xD;
           approached the study tasks and whether they experienced any discomfort in the MRI&#xD;
           scanner or while wearing the fNIRS system.&#xD;
&#xD;
        -  Upon study completion, the investigator will tell the participant about the general&#xD;
           goals of the study and answer any questions that they may have.&#xD;
&#xD;
      The procedure can be stopped at any time.&#xD;
&#xD;
      The study will conclude with debriefing and reimbursement.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">January 8, 2020</completion_date>
  <primary_completion_date type="Actual">January 8, 2020</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>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Increased activation of anterior insula from pre-training to post-training</measure>
    <time_frame>Pre-training session (baseline visit); post-training session (approximately one week later)</time_frame>
    <description>Both young and older participants can be trained in up-regulation of anterior insula activity, by means of contingent neurofeedback (rt-fMRI), reflecting continued plasticity of brain regions associated with affective processing.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gained volitional control over activity in anterior insula improves emotion perception from pre-training to post-training</measure>
    <time_frame>Pre-training (baseline visit); post-training visit (approximately one week later)</time_frame>
    <description>Participants in the experimental group compared to the control group will benefit more from neurofeedback, in that they will show relatively greater improvement in emotion perception after the rt-fMRI training, reflecting a potential for improvement of neural dysregulation related to affective processing.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Aging</condition>
  <condition>Emotion</condition>
  <arm_group>
    <arm_group_label>Anterior insula cortex activation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive training sessions using a special feedback technique to learn to actively increase blood flow in the front of the brain, while thinking of and viewing emotional faces, scenes, and text.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Primary auditory cortex activation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will have training sessions using a special feedback technique to learn to actively increase blood flow in the back of the brain while thinking of and viewing emotional faces, scenes, and text.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Brain activity training - anterior insula</intervention_name>
    <description>training sessions using a special feedback technique to learn to actively increase blood flow in the front of the brain</description>
    <arm_group_label>Anterior insula cortex activation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Brain activity training - medial prefrontal cortex</intervention_name>
    <description>training sessions using a special feedback technique to learn to actively increase blood flow in the back of the brain</description>
    <arm_group_label>Primary auditory cortex activation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Between the ages of 18-30 years or 63-90 years&#xD;
&#xD;
          -  Right-handed&#xD;
&#xD;
          -  Native English speaker&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or possibly pregnant&#xD;
&#xD;
          -  Claustrophobia&#xD;
&#xD;
          -  Large pieces of metal in the body, particularly in the face and neck.&#xD;
&#xD;
          -  Piercings or metal implants that cannot be removed from the body&#xD;
&#xD;
          -  Surgery on the brain or any prior serious brain damage or disease&#xD;
&#xD;
          -  Dementia or severe cognitive disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Natalie Ebner, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida, Department of Psychology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32611-2250</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.frontiersin.org/articles/10.3389/fnagi.2016.00239/full</url>
    <description>Real-Time fMRI in Neuroscience Research and Its Use in Studying the Aging Brain</description>
  </link>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>July 10, 2014</study_first_submitted>
  <study_first_submitted_qc>July 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 18, 2014</study_first_posted>
  <last_update_submitted>January 21, 2020</last_update_submitted>
  <last_update_submitted_qc>January 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Emotional Aging</keyword>
  <keyword>Neurofeedback</keyword>
  <!-- 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/NCT02194907
org study id: IRB201300814 closed
nct id: NCT02194907
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will determine whether brain activity can be modified and improves performance on
      a task by showing participants live 'video feed' of their brains on advanced imaging
      technology. The study is particularly interested in brain regions that have been shown to be
      relevant for emotions, specifically the anterior insula and the medial prefrontal cortex.
      Advanced technology will map the brain using magnetic pulses with a real-time functional
      Magnetic Resonance Imaging (rt-fMRI) machine.
Overview: All participants of both age groups will be randomly divided (like tossing a coin)
      into two groups:

        -  One group will have training sessions using a special feedback technique to learn to
           actively increase blood flow in the front of the brain, while thinking of and viewing
           emotional faces, scenes, and text

        -  The other group will have training sessions using a special feedback technique to learn
           to actively increase blood flow in the back of the brain while thinking of and viewing
           emotional faces, scenes, and text

      Further, each of these two groups will be divided into two sub-groups that are different with
      respect to the training procedure that is used:

      * Use of a 3.0 Tesla, 32-channel Seimens whole-body human MR scanner (fMRI) during training,
      that has not been associated with any known side effects or safety risks

      Number of Study Visits:

      This study has the following parts: A pre-training visit, six training visits, and a
      post-training visit.

      With a few exceptions as explained below, the procedures during pre-training, training, and
      post-training visits are identical.

        -  At the beginning of the first visit, the investigator will tell the participant about
           the study and what is involved and will ask them to sign a consent form. The participant
           may ask as many questions as they would like before deciding about study participation.

        -  For each of the visits, the investigator will review questions with the participant
           about their health to ensure their eligibility to undergo fMRI on the day of testing.

        -  Also for each visit, the investigator will ask the participant to respond to a short
           questionnaire related to their current mood.

        -  In the pre-training and the post-training visits only, the investigator will ask the
           participant to answer questions about their feelings, emotions, and thoughts.

        -  For each of the participant's visits, they will spend 50-60 minutes either in the MRI
           scanner, while viewing pictures and text on a screen. During this time, pictures of the
           participant's brain at work and at rest will be acquired. In the training visits only,
           the participant will learn to increase blood flow in certain brain regions with the help
           of information presented to them on the screen.

        -  For each of the participant's visits, they will be asked to respond to a short
           questionnaire related to their current mood.

        -  In the pre-training/post-training visits only, the investigator will ask the participant
           to answer questions about their feelings, emotions, and thoughts as well as their
           personality. The participant will also perform brief tests related to the thinking
           process.

        -  At the end of each visit, the participant will complete a questionnaire about how they
           approached the study tasks and whether they experienced any discomfort in the MRI
           scanner or while wearing the fNIRS system.

        -  Upon study completion, the investigator will tell the participant about the general
           goals of the study and answer any questions that they may have.

      The procedure can be stopped at any time.

      The study will conclude with debriefing and reimbursement.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Increased activation of anterior insula from pre-training to post-training
time frame: Pre-training session (baseline visit); post-training session (approximately one week later)
description: Both young and older participants can be trained in up-regulation of anterior insula activity, by means of contingent neurofeedback (rt-fMRI), reflecting continued plasticity of brain regions associated with affective processing.
measure: Gained volitional control over activity in anterior insula improves emotion perception from pre-training to post-training
time frame: Pre-training (baseline visit); post-training visit (approximately one week later)
description: Participants in the experimental group compared to the control group will benefit more from neurofeedback, in that they will show relatively greater improvement in emotion perception after the rt-fMRI training, reflecting a potential for improvement of neural dysregulation related to affective processing.
arm group label: Anterior insula cortex activation
arm group type: Active Comparator
description: Participants will receive training sessions using a special feedback technique to learn to actively increase blood flow in the front of the brain, while thinking of and viewing emotional faces, scenes, and text.
arm group label: Primary auditory cortex activation
arm group type: Active Comparator
description: Participants will have training sessions using a special feedback technique to learn to actively increase blood flow in the back of the brain while thinking of and viewing emotional faces, scenes, and text.
intervention type: Behavioral
intervention name: Brain activity training - anterior insula
description: training sessions using a special feedback technique to learn to actively increase blood flow in the front of the brain
arm group label: Anterior insula cortex activation
intervention type: Behavioral
intervention name: Brain activity training - medial prefrontal cortex
description: training sessions using a special feedback technique to learn to actively increase blood flow in the back of the brain
arm group label: Primary auditory cortex activation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Natalie Ebner, PhD
role: Principal Investigator
affiliation: University of Florida, Department of Psychology
facility: 
country: United States
url: http://www.frontiersin.org/articles/10.3389/fnagi.2016.00239/full
description: Real-Time fMRI in Neuroscience Research and Its Use in Studying the Aging Brain
responsible party type: Sponsor