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/NCT05986019</url>
    </required_header>
    <id_info>
      <org_study_id>Pro00127562</org_study_id>
      <nct_id>NCT05986019</nct_id>
    </id_info>
    <brief_title>Transcranial Focused Ultrasound (tFUS) Modulation of Reward Network</brief_title>
    <official_title>Evaluating the Effects of Transcranial Focused Ultrasound (tFUS) on Fronto-striatal Resting State Functional Connectivity in Healthy Individuals</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Medical University of South Carolina</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Medical University of South Carolina</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>
        Aim: Evaluate whether sonicating the Nucleus Accumbens (NAc) with transcranial focused&#xD;
        ultrasound modifies functional connectivity between the NAc and the prefrontal cortex (PFC).&#xD;
  &#xD;
        In this single visit, open-label pilot trial, we plan to evaluate whether transcranial&#xD;
        focused ultrasound (tFUS), delivered to the nucleus accumbens (NAc) within the magnetic&#xD;
        resonance imaging (MRI) scanner will impact resting state functional connectivity between the&#xD;
        NAc and functionally connected brain regions like the prefrontal cortex (PFC) and the&#xD;
        anterior cingulate cortex (ACC) in up to 10 healthy individuals.&#xD;
  &#xD;
        HYPOTHESIS : tFUS will reduce prefrontal cortex (PFC)-NAc functional connectivity, in healthy&#xD;
        individuals. We will investigate this hypothesis by administering tFUS within to MRI scanner&#xD;
        to healthy individuals and conduct resting state functional neuroimaging before- and after&#xD;
        the tFUS stimulation.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 25, 2023</start_date>
    <completion_date type="Anticipated">December 25, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 25, 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>Active or Sham tFUS</intervention_model_description>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>Single-blind</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Resting State Functional Connectivity</measure>
      <time_frame>20 minutes</time_frame>
      <description>The main outcomes of this study are brain imaging related. Using a neuroimaging technique called resting state functional connectivity, which is a statistical dependence between time series of electro-physiological activity and (de)oxygenated blood levels in distinct regions of the brain. Functional connectivity &quot;strength calculation&quot; determines whether the activity between a pair of brain regions covaries or correlates over time. We will investigate the strength of the functional connectivity between the stimulation target (Nucleus Accumbens) and connected areas, including the prefrontal cortex, hippocampus, amygdala, and sensory areas of the brain at baseline, and then will determine whether tFUS increases or decreases the resting-state connectivity between these regions after the NAC has been stimulated.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Healthy</condition>
    <arm_group>
      <arm_group_label>Active tFUS</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>tFUS will be administered within the MRI scanner. Participants receive two, 10-min sessions of active tFUS spread 10 min apart targeting the nucleus accumbens.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sham tFUS</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>The sham sessions will include a transducer that is connected in a similar fashion to that of active tFUS, however the cable will not be plugged into the system, thus no ultrasound will be delivered to the participant. Participants will not know or be told whether they are receiving active- or sham- tFUS.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>transcranial focused ultrasound (tFUS)</intervention_name>
      <description>Transcranial focused ultrasound (tFUS) is a promising new technology that is both noninvasive and may be focally applied to deep brain targets. tFUS utilizes transducers which contain piezoelectric elements to produce pulses of ultrasonic waves that summate deep in the brain. Transcranial focused ultrasound (tFUS) uses a single transducer fixed in a head-worn apparatus on the scalp to produce ultrasonic waves deep into the brain.</description>
      <arm_group_label>Active tFUS</arm_group_label>
      <arm_group_label>Sham tFUS</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 18-65&#xD;
  &#xD;
            -  Have the capacity and ability to provide one's own consent and sign the informed&#xD;
               consent document&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Contraindicated for MRI.&#xD;
  &#xD;
            -  Any current or recent untreated medical, neurological, or psychiatric conditions&#xD;
  &#xD;
            -  Metal implant devices in the head, heart, or neck.&#xD;
  &#xD;
            -  History of brain surgery.&#xD;
  &#xD;
            -  History of myocardial infarction or arrhythmia, bradycardia.&#xD;
  &#xD;
            -  Personal or family history of seizure or epilepsy or personal use of medications that&#xD;
               substantially reduce seizure threshold (e.g., olanzapine, chlorpromazine, lithium).&#xD;
  &#xD;
            -  Personal history of head injury, concussion, or self-report of moderate to severe&#xD;
               traumatic brain injury.&#xD;
  &#xD;
            -  Individuals suffering from frequent/severe headaches.&#xD;
  &#xD;
            -  Individuals with a reported history of psychosis or mania, or individuals who are&#xD;
               actively manic or psychotic.&#xD;
  &#xD;
            -  Regular or recent pain medication use&#xD;
  &#xD;
            -  Moderate to severe alcohol use (&gt;3 drinks/day) or illicit substance use (urine&#xD;
               confirmed).&#xD;
  &#xD;
            -  Persons who are pregnant or lactating&#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_contact>
      <last_name>Bashar Badran, PhD</last_name>
      <phone>843-792-6076</phone>
      <email>badran@musc.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Medical University of South Carolina Institute of Psychiatry</name>
        <address>
          <city>Charleston</city>
          <state>South Carolina</state>
          <zip>29425</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Bashar W Badran, PhD</last_name>
        <phone>843-792-6076</phone>
        <email>badran@musc.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 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>Bashar Badran</investigator_full_name>
      <investigator_title>Assistant Professor-Faculty</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/NCT05986019
  org study id: Pro00127562
  nct id: NCT05986019
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Aim: Evaluate whether sonicating the Nucleus Accumbens (NAc) with transcranial focused
        ultrasound modifies functional connectivity between the NAc and the prefrontal cortex (PFC).
  
        In this single visit, open-label pilot trial, we plan to evaluate whether transcranial
        focused ultrasound (tFUS), delivered to the nucleus accumbens (NAc) within the magnetic
        resonance imaging (MRI) scanner will impact resting state functional connectivity between the
        NAc and functionally connected brain regions like the prefrontal cortex (PFC) and the
        anterior cingulate cortex (ACC) in up to 10 healthy individuals.
  
        HYPOTHESIS : tFUS will reduce prefrontal cortex (PFC)-NAc functional connectivity, in healthy
        individuals. We will investigate this hypothesis by administering tFUS within to MRI scanner
        to healthy individuals and conduct resting state functional neuroimaging before- and after
        the tFUS stimulation.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Active or Sham tFUS
  primary purpose: Basic Science
  masking: Single (Participant)
  masking description: Single-blind
  measure: Resting State Functional Connectivity
  time frame: 20 minutes
  description: The main outcomes of this study are brain imaging related. Using a neuroimaging technique called resting state functional connectivity, which is a statistical dependence between time series of electro-physiological activity and (de)oxygenated blood levels in distinct regions of the brain. Functional connectivity "strength calculation" determines whether the activity between a pair of brain regions covaries or correlates over time. We will investigate the strength of the functional connectivity between the stimulation target (Nucleus Accumbens) and connected areas, including the prefrontal cortex, hippocampus, amygdala, and sensory areas of the brain at baseline, and then will determine whether tFUS increases or decreases the resting-state connectivity between these regions after the NAC has been stimulated.
  arm group label: Active tFUS
  arm group type: Experimental
  description: tFUS will be administered within the MRI scanner. Participants receive two, 10-min sessions of active tFUS spread 10 min apart targeting the nucleus accumbens.
  arm group label: Sham tFUS
  arm group type: Sham Comparator
  description: The sham sessions will include a transducer that is connected in a similar fashion to that of active tFUS, however the cable will not be plugged into the system, thus no ultrasound will be delivered to the participant. Participants will not know or be told whether they are receiving active- or sham- tFUS.
  intervention type: Device
  intervention name: transcranial focused ultrasound (tFUS)
  description: Transcranial focused ultrasound (tFUS) is a promising new technology that is both noninvasive and may be focally applied to deep brain targets. tFUS utilizes transducers which contain piezoelectric elements to produce pulses of ultrasonic waves that summate deep in the brain. Transcranial focused ultrasound (tFUS) uses a single transducer fixed in a head-worn apparatus on the scalp to produce ultrasonic waves deep into the brain.
  arm group label: Active tFUS
  arm group label: Sham tFUS
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Bashar Badran, PhD
  phone: 843-792-6076
  email: badran@musc.edu
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Medical University of South Carolina
  investigator full name: Bashar Badran
  investigator title: Assistant Professor-Faculty
  sharing ipd: No