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/NCT05977439</url>
    </required_header>
    <id_info>
      <org_study_id>00129566</org_study_id>
      <nct_id>NCT05977439</nct_id>
    </id_info>
    <brief_title>RECOVERS - Realigning Emotion and COgnition Via prEcision Regulation networkS</brief_title>
    <official_title>RECOVERS - Realigning Emotion and COgnition Via prEcision Regulation networkS - Phase I Study: Multimodal Computational Modeling of Cognitive Flexibility and Emotion Regulation Networks</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Medical University of South Carolina</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Columbia University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Wisconsin, Madison</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Oklahoma</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Defense Advanced Research Projects Agency</agency>
        <agency_class>U.S. Fed</agency_class>
      </collaborator>
    </sponsors>
    <source>Medical University of South Carolina</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        In this research study, the investigators are using examining how brain activity (electrical&#xD;
        and blood flow) changes during tests of emotional processing and attention and memory in the&#xD;
        magnetic resonance imaging (MRI) scanner. Investigators are also using non-invasive brain&#xD;
        stimulation to probe different parts of the brain and measuring brain activity (electrical&#xD;
        and blood flow). This study includes healthy participants and researchers hope this will help&#xD;
        us develop improved brain-based treatments for emotional difficulties like depression.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Investigators hypothesize that targeted neuroplastic changes induced by individually-tailored&#xD;
        rTMS will substantially reduce clinical symptoms underlying depression, anxiety and&#xD;
        suicidality, and in general, revolutionize non-invasive treatments of mental health&#xD;
        disorders. Investigators hypothesize that functional coupling in cognitive flexibility (CF)&#xD;
        and emotion regulation (ER) networks is indexed by the phase of the brain's alpha&#xD;
        oscillations. Using a novel integrated instrument that enables simultaneous functional&#xD;
        magnetic resonance imaging (fMRI), electroencephalography (EEG) and transcranial magnetic&#xD;
        stimulation (TMS), investigators propose to identify individualized stimulation parameters&#xD;
        that reflect the strongest coupling of the CF/ER networks. The neuromechanistic model further&#xD;
        posits that by applying repetitive TMS (rTMS) with these individualized parameters, one can&#xD;
        induce entrainment in brain networks that drive neuroplastic changes in CF and ER. This&#xD;
        initial Phase I Task 3 sub-study is a proof-of-principle study in healthy control&#xD;
        participants.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2028</completion_date>
    <primary_completion_date type="Anticipated">October 1, 2027</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Change in reaction time (RT) tasks - Incongruent Stimuli</measure>
      <time_frame>Day 1, Day 2, Day 3</time_frame>
      <description>Tasks will be used to see differences between incongruent emotional stimuli.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in reaction time (RT) tasks - Congruent Stimuli</measure>
      <time_frame>Day 1, Day 2, Day 3</time_frame>
      <description>Tasks will be used to see differences between congruent emotional stimuli.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in reaction time (RT) tasks and accuracy - Incongruent Stimuli</measure>
      <time_frame>Day 1, Day 2, Day 3</time_frame>
      <description>Tasks will be used to see differences between incongruent emotional stimuli.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in reaction time (RT) tasks and accuracy - Congruent Stimuli</measure>
      <time_frame>Day 1, Day 2, Day 3</time_frame>
      <description>Tasks will be used to see differences between congruent emotional stimuli.</description>
    </primary_outcome>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Healthy</condition>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>fMRI-EEG-TMS</intervention_name>
      <description>Participants will undergo a magnetic resonance imaging (MRI) scan with combined electroencephalography (EEG), and single-pulse transcranial magnetic stimulation (TMS) while completing cognitive flexibility (CF) and emotion recognition (CR) tasks.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Participants are healthy volunteers from the community.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male or female&#xD;
  &#xD;
            -  Age 18-65&#xD;
  &#xD;
            -  Endorse good health with no history of mental or physical illness or implanted metal&#xD;
  &#xD;
            -  English as a primary language&#xD;
  &#xD;
            -  Capacity to consent&#xD;
  &#xD;
            -  Negative urine pregnancy test if female of childbearing potential&#xD;
  &#xD;
            -  Willingness to adhere to the study schedule and assessments&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Any current psychiatric diagnosis or current Clinical Global Impression ratings of&#xD;
               psychiatric illness &gt; 1&#xD;
  &#xD;
            -  Neurodevelopmental disorders, history of CNS disease, concussion, overnight&#xD;
               hospitalization, or other neurologic sequela, tumors, seizures, meningitis,&#xD;
               encephalitis, or abnormal CT or MRI of the brain&#xD;
  &#xD;
            -  Any psychotropic medication is taken within 5 half-lives of procedure time&#xD;
  &#xD;
            -  Any head trauma resulting in loss of consciousness&#xD;
  &#xD;
            -  Visual impairment (except the use of glasses)&#xD;
  &#xD;
            -  Inability to complete cognitive testing&#xD;
  &#xD;
            -  Active participation or plan for enrollment in clinical trial affecting the&#xD;
               psychosocial function&#xD;
  &#xD;
            -  Repeated abuse or dependence upon drugs (excluding nicotine and caffeine) or taking&#xD;
               medications including stimulants, modafinil, thyroid medication, or steroids&#xD;
  &#xD;
            -  Implanted devices/ferrous metal of any kind&#xD;
  &#xD;
            -  History of seizure or epilepsy, currently taking medications that lower seizure&#xD;
               thresholds&#xD;
  &#xD;
            -  Claustrophobia or other conditions that would prevent the MRI assessment.&#xD;
  &#xD;
            -  Pregnancy (or suspected/possible pregnancy or plan to become pregnant in the short&#xD;
               term).&#xD;
  &#xD;
            -  Urine Pregnancy Test: If the subject is a woman of childbearing potential and /or a&#xD;
               man capable of fathering a child before, during, and/or after participation&#xD;
               precautions should be taken. Examples of acceptable methods of birth control for&#xD;
               participants involved in the study include birth control pills, patches, IUDs,&#xD;
               condoms, sponges, diaphragm with spermicide, or avoiding sexual activity that could&#xD;
               cause the subject to become pregnant.&#xD;
  &#xD;
            -  Inability to adhere to the treatment schedule.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Lisa McTeague, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Medical University of South Carolina</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sarah Huffman, BA</last_name>
      <phone>843-792-5560</phone>
      <email>huffmans@musc.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Lisa McTeague, PhD</last_name>
      <phone>843-792-8274</phone>
      <email>mcteague@musc.edu</email>
    </overall_contact_backup>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 29, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Medical University of South Carolina</investigator_affiliation>
      <investigator_full_name>Lisa McTeague, PhD</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <keyword>healthy volunteer</keyword>
    <keyword>transcranial magnetic stimulation (TMS)</keyword>
    <keyword>electroencephalography (EEG)</keyword>
    <keyword>magnetic resonance imaging (MRI)</keyword>
    <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/NCT05977439
  org study id: 00129566
  nct id: NCT05977439
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  In this research study, the investigators are using examining how brain activity (electrical
        and blood flow) changes during tests of emotional processing and attention and memory in the
        magnetic resonance imaging (MRI) scanner. Investigators are also using non-invasive brain
        stimulation to probe different parts of the brain and measuring brain activity (electrical
        and blood flow). This study includes healthy participants and researchers hope this will help
        us develop improved brain-based treatments for emotional difficulties like depression.
  Investigators hypothesize that targeted neuroplastic changes induced by individually-tailored
        rTMS will substantially reduce clinical symptoms underlying depression, anxiety and
        suicidality, and in general, revolutionize non-invasive treatments of mental health
        disorders. Investigators hypothesize that functional coupling in cognitive flexibility (CF)
        and emotion regulation (ER) networks is indexed by the phase of the brain's alpha
        oscillations. Using a novel integrated instrument that enables simultaneous functional
        magnetic resonance imaging (fMRI), electroencephalography (EEG) and transcranial magnetic
        stimulation (TMS), investigators propose to identify individualized stimulation parameters
        that reflect the strongest coupling of the CF/ER networks. The neuromechanistic model further
        posits that by applying repetitive TMS (rTMS) with these individualized parameters, one can
        induce entrainment in brain networks that drive neuroplastic changes in CF and ER. This
        initial Phase I Task 3 sub-study is a proof-of-principle study in healthy control
        participants.
  observational model: Case-Only
  time perspective: Prospective
  measure: Change in reaction time (RT) tasks - Incongruent Stimuli
  time frame: Day 1, Day 2, Day 3
  description: Tasks will be used to see differences between incongruent emotional stimuli.
  measure: Change in reaction time (RT) tasks - Congruent Stimuli
  time frame: Day 1, Day 2, Day 3
  description: Tasks will be used to see differences between congruent emotional stimuli.
  measure: Change in reaction time (RT) tasks and accuracy - Incongruent Stimuli
  time frame: Day 1, Day 2, Day 3
  description: Tasks will be used to see differences between incongruent emotional stimuli.
  measure: Change in reaction time (RT) tasks and accuracy - Congruent Stimuli
  time frame: Day 1, Day 2, Day 3
  description: Tasks will be used to see differences between congruent emotional stimuli.
  intervention type: Device
  intervention name: fMRI-EEG-TMS
  description: Participants will undergo a magnetic resonance imaging (MRI) scan with combined electroencephalography (EEG), and single-pulse transcranial magnetic stimulation (TMS) while completing cognitive flexibility (CF) and emotion recognition (CR) tasks.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Lisa McTeague, PhD
  role: Principal Investigator
  affiliation: Medical University of South Carolina
  last name: Sarah Huffman, BA
  phone: 843-792-5560
  email: huffmans@musc.edu
  last name: Lisa McTeague, PhD
  phone: 843-792-8274
  email: mcteague@musc.edu
  responsible party type: Principal Investigator
  investigator affiliation: Medical University of South Carolina
  investigator full name: Lisa McTeague, PhD
  investigator title: Associate Professor
  sharing ipd: No