<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/NCT03232489</url>
  </required_header>
  <id_info>
    <org_study_id>20161363</org_study_id>
    <nct_id>NCT03232489</nct_id>
  </id_info>
  <brief_title>Study for the Evaluation of the Feasibility of Applying Advanced MRI Scanning in Pediatric Clinical Practice</brief_title>
  <official_title>Open Label Study for the Evaluation of the Feasibility of Applying Advanced MRI Scanning in Pediatric Clinical Practice</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Neurological Associates of West Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Neurological Associates of West Los Angeles</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is to evaluate the feasibility in conducting advanced MRI&#xD;
      sequences in a pediatric clinical setting. The study will be observational in nature, and&#xD;
      will only evaluate the studies of pediatric patients who have already been prescribed an&#xD;
      advanced MRI for clinical neurological purposes. The only difference for the subject in&#xD;
      participating in this study is that the data and information about their scan can be used and&#xD;
      disclosed for research purposes, i.e. understanding if the time of the scan, patient comfort,&#xD;
      and quality of the data are feasible. Standard MRI's have been extremely beneficial in the&#xD;
      diagnosis and assessment of disease, injury, and anomalies throughout the body. Adding&#xD;
      advanced MRI sequences to the arsenal of current standard MRI sequences, as well as analyzing&#xD;
      the clinical significance of the data, may improve the benefits of MRI in the future. Within&#xD;
      this scope, the study will be looking at the following factors:&#xD;
&#xD;
        1. The total time of the scan, including:&#xD;
&#xD;
             -  Patient arrival time/lateness&#xD;
&#xD;
             -  Patient preparation time&#xD;
&#xD;
             -  Time scanner is being occupied&#xD;
&#xD;
             -  Patient compliance (is the patient continually stopping the study for breaks, fear,&#xD;
                movement, etc.)&#xD;
&#xD;
        2. Patient dropout rate, including:&#xD;
&#xD;
             -  Change of mind&#xD;
&#xD;
             -  Cost of study is too much&#xD;
&#xD;
             -  Failure to finish the scan&#xD;
&#xD;
        3. Usability of data, including:&#xD;
&#xD;
             -  Movement artifact&#xD;
&#xD;
             -  Patient requiring re-scan for any reason&#xD;
&#xD;
      The scan will consist of two to five advanced MRI sequences that will average between 7-15&#xD;
      minutes each, in addition to a routine 5 minute standard MRI sequence. The variability in the&#xD;
      number of advanced sequences depends on the prescription and patient history. All sequences&#xD;
      are performed using a 1.5 Tesla Siemens MRI scanner at Westwood Open MRI, a 3 Tesla GE&#xD;
      scanner at Tower Saint John's Imaging, or a 3 Tesla Siemens MRI scanner at Resolution&#xD;
      Imaging. All scanners are FDA-approved.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      An MPRAGE is a high quality anatomical image of the brain. This is used as an anatomical&#xD;
      overlay, so that all data collected from the advanced sequences below can be correlated with&#xD;
      the correct brain areas in three-dimensional space.&#xD;
&#xD;
        1. Resting BOLD - BOLD stands for blood oxygen level dependent. This functional sequence&#xD;
           allows for the viewing of the thinking brain at rest, and looks at brain areas that are&#xD;
           functionally working together at the same time. The brain is in one of its most active&#xD;
           states when it is at rest, and literature has shown that a few neurological illnesses&#xD;
           such as OCD, depression, and pain have been associated with analyzing the data in this&#xD;
           sequence.&#xD;
&#xD;
        2. Arterial Spin Labeling (ASL) - ASL tracks the blood flow in the brain visually and gives&#xD;
           a statistical value of how much blood is in each region in cc's per 100 grams of brain&#xD;
           per second.&#xD;
&#xD;
        3. Diffusion Tensor Imaging (DTI) - DTI tractography shows the different fiber tracts in&#xD;
           the brain using a 3D model. Fiber tracts are the physical neural pathways that can show&#xD;
           disruption or connection in communication between different areas of the brain. This is&#xD;
           an effective technique when looking at traumatic brain injury.&#xD;
&#xD;
        4. Magnetic Resonance Spectroscopy (MRS) - MRS measures the ratios of select chemical&#xD;
           compounds in the brain in relation to each other. This has shown to be effective in&#xD;
           analyzing memory loss, dementia, and Alzheimer's type disorders.&#xD;
&#xD;
        5. Stimulated BOLD - The same sequence as the resting BOLD, except the brain is being&#xD;
           scanned during the completion of a task, instead of rest. By specifying the task&#xD;
           (visual, problem solving, language, etc.), the different areas of the brain working&#xD;
           together to complete this task can be imaged. This is very effective for task-specific&#xD;
           symptoms and deficits.&#xD;
&#xD;
      The methods and procedures in this study are all under the observational category. MRI's are&#xD;
      FDA approved and are non-experimental devices. The goal of this research is to assess the&#xD;
      feasibility of the scan itself, so everything done with respect to the scan is considered&#xD;
      observational in nature. If the subject drops out of the study, anything described in this&#xD;
      protocol will still be able available to the subject as standard medical care. The&#xD;
      observational procedures will involve recording data for the advanced MRI scans, and no&#xD;
      information will be shared for research if the subject does not sign the consent form.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>July 2016</start_date>
  <completion_date type="Anticipated">January 2025</completion_date>
  <primary_completion_date type="Anticipated">January 2025</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>Number of subjects who successfully complete an fMRI scan</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>In order to assess scan feasibility, we will keep track of the total number of patients who sign the consent form and are able to complete the fMRI scan.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subject appointment time vs. subject arrival time</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>For each study subject, we will record the scheduled fMRI appointment time vs. the time that the subject arrives.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time it takes subject to get from checked-in to start of scan (in minutes)</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>For each study subject, we will record how long it takes to transition the subject from check-in to starting the fMRI scan.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>How long was the scanner unoccupied (in minutes)</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>We will record the length of time that the scanner is unoccupied in between scans.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number and type of sequences performed</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>For each study subject, we will record the number and type of sequences performed for the fMRI scan, e.g. MPRAGE, ASL, Resting BOLD, etc.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of scan (in minutes)</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>For each study subject, we will record the total amount of time it takes to complete the fMRI scan.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>How many times did the subject pause the scan (if any) and for how long (in minutes)</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>For each study subject, we will record the number of times a subject pauses the fMRI scan and the duration of each pause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Did the subject finish the scan</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>For each study subject, we will record whether or not the subject was able to complete the fMRI scan.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Did the subject cancel the scan, and for what reason</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>For each study subject, we will record whether the patient canceled the fMRI scan and for what reason.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Did the subject cause too much movement artifact</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>For each study subject, we will record whether the post-processed fMRI data shows too much motion artifact, which could lead to the subject needing to be re-scanned.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Does the subject need to be re-scanned, and for what reason</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>For each study subject, we will record whether or not the subject requires a re-scan and for what reason.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Neurodevelopmental Disorders</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The subjects in this research study will be recruited by routine medical office exam.The&#xD;
        ages for the subjects in this study will range from neonates to 18 years old.The gender&#xD;
        distribution for this study will aim for a ratio of 50:50 male to female. There are no&#xD;
        enrollment restrictions based upon race or ethnic origin. There are also no additional&#xD;
        benefits, risks, advantages, or disadvantages based off of any race or ethnic origin.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        In order for a subject to be considered for this study, the following criteria are&#xD;
        required:&#xD;
&#xD;
          -  The subject is between the ages of neonate-18 years old&#xD;
&#xD;
          -  The subject clinically needs an advanced MRI&#xD;
&#xD;
          -  The assent of the subject and the agreement of parent(s) or guardian(s) to the&#xD;
             participation of their child or ward in research, in accordance with the regulations&#xD;
             set forth in the Belmont Report&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        In order for a subject to be considered for this study, he/she may NOT have any of the&#xD;
        following items in which cannot be removed prior to the MRI exam. A subject that can remove&#xD;
        any of the following prior to the MRI exam will still be considered for the study.&#xD;
&#xD;
          -  Aneurism clips&#xD;
&#xD;
          -  Cardiac pacemaker&#xD;
&#xD;
          -  Implanted cardioinverter defibrillator&#xD;
&#xD;
          -  Electronic implant or device&#xD;
&#xD;
          -  Magnetically activated implant or device&#xD;
&#xD;
          -  Neurostimulation system&#xD;
&#xD;
          -  Spinal cord stimulator&#xD;
&#xD;
          -  Internal electrodes or wires&#xD;
&#xD;
          -  Bone growth/bone fusion stimulator&#xD;
&#xD;
          -  Cochlear, otologic, or other ear implant&#xD;
&#xD;
          -  Insulin or other infusion pump&#xD;
&#xD;
          -  Implanted drug infusion device&#xD;
&#xD;
          -  Any type of prosthesis (eye, penile, etc.)&#xD;
&#xD;
          -  Heart valve prosthesis&#xD;
&#xD;
          -  Eyelid spring or wire&#xD;
&#xD;
          -  Artificial or prosthetic limb&#xD;
&#xD;
          -  No Metallic stent, filter, or coil&#xD;
&#xD;
          -  Shunt (spinal or intraventricular)&#xD;
&#xD;
          -  Vascular access port and/or catheter&#xD;
&#xD;
          -  Radiation seeds or implants&#xD;
&#xD;
          -  Swan-Ganz or thermodilution catheter&#xD;
&#xD;
          -  Medication patch (Nicotine, Nitroglycerine)&#xD;
&#xD;
          -  Any metallic fragment or foreign body&#xD;
&#xD;
          -  Wire mesh implant&#xD;
&#xD;
          -  Tissue expander (e.g., breast)&#xD;
&#xD;
          -  Surgical staples, clips, or metallic sutures&#xD;
&#xD;
          -  Joint replacement (hip, knee, etc.)&#xD;
&#xD;
          -  Bone/joint pin, screw, nail, wire, plate, etc.&#xD;
&#xD;
          -  IUD, diaphragm, or pessary&#xD;
&#xD;
          -  Dentures or partial plates&#xD;
&#xD;
          -  Tattoo or permanent makeup&#xD;
&#xD;
          -  Body piercing jewelry&#xD;
&#xD;
          -  Hearing aid&#xD;
&#xD;
        As well as:&#xD;
&#xD;
          -  Breathing problem or motion disorder&#xD;
&#xD;
          -  Severe claustrophobia&#xD;
&#xD;
        Any subjects from the following categories/groups will NOT be included in the study:&#xD;
&#xD;
          -  Prisoners&#xD;
&#xD;
          -  Poor/uninsured&#xD;
&#xD;
          -  Institutionalized&#xD;
&#xD;
          -  Limited or non-readers&#xD;
&#xD;
          -  Non-English speaking subjects&#xD;
&#xD;
          -  Wards of the state&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Nursing home residents recruited in the nursing home&#xD;
&#xD;
          -  Students of PI or study staff&#xD;
&#xD;
          -  Students recruited in the educational setting (school, class, etc.)&#xD;
&#xD;
          -  Employees directly supervised by the PI or sub-investigator&#xD;
&#xD;
          -  Employees of research site or sponsor&#xD;
&#xD;
          -  Military personnel recruited by military personnel&#xD;
&#xD;
          -  Cognitively impaired&#xD;
&#xD;
          -  Adult subjects that cannot consent for themselves&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sheldon Jordan, MD, FAAN</last_name>
    <role>Principal Investigator</role>
    <affiliation>Neurological Associates of West Los Angeles</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sheldon Jordan, MD, FAAN</last_name>
    <phone>3108295968</phone>
    <email>shellyj@aol.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Robin Blades, BA</last_name>
    <phone>3108295968</phone>
    <phone_ext>214</phone_ext>
    <email>rblades@theneuroassociates.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Neurological Associates of West Los Angeles</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90403</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ann Green</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>June 12, 2017</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <last_update_submitted>September 26, 2022</last_update_submitted>
  <last_update_submitted_qc>September 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Neurological Associates of West Los Angeles</investigator_affiliation>
    <investigator_full_name>Sheldon Jordan</investigator_full_name>
    <investigator_title>Neurologist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neurodevelopmental Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03232489
org study id: 20161363
nct id: NCT03232489
lead sponsor: 
has dmc: No
The purpose of this research study is to evaluate the feasibility in conducting advanced MRI
      sequences in a pediatric clinical setting. The study will be observational in nature, and
      will only evaluate the studies of pediatric patients who have already been prescribed an
      advanced MRI for clinical neurological purposes. The only difference for the subject in
      participating in this study is that the data and information about their scan can be used and
      disclosed for research purposes, i.e. understanding if the time of the scan, patient comfort,
      and quality of the data are feasible. Standard MRI's have been extremely beneficial in the
      diagnosis and assessment of disease, injury, and anomalies throughout the body. Adding
      advanced MRI sequences to the arsenal of current standard MRI sequences, as well as analyzing
      the clinical significance of the data, may improve the benefits of MRI in the future. Within
      this scope, the study will be looking at the following factors:

        1. The total time of the scan, including:

             -  Patient arrival time/lateness

             -  Patient preparation time

             -  Time scanner is being occupied

             -  Patient compliance (is the patient continually stopping the study for breaks, fear,
                movement, etc.)

        2. Patient dropout rate, including:

             -  Change of mind

             -  Cost of study is too much

             -  Failure to finish the scan

        3. Usability of data, including:

             -  Movement artifact

             -  Patient requiring re-scan for any reason

      The scan will consist of two to five advanced MRI sequences that will average between 7-15
      minutes each, in addition to a routine 5 minute standard MRI sequence. The variability in the
      number of advanced sequences depends on the prescription and patient history. All sequences
      are performed using a 1.5 Tesla Siemens MRI scanner at Westwood Open MRI, a 3 Tesla GE
      scanner at Tower Saint John's Imaging, or a 3 Tesla Siemens MRI scanner at Resolution
      Imaging. All scanners are FDA-approved.
An MPRAGE is a high quality anatomical image of the brain. This is used as an anatomical
      overlay, so that all data collected from the advanced sequences below can be correlated with
      the correct brain areas in three-dimensional space.

        1. Resting BOLD - BOLD stands for blood oxygen level dependent. This functional sequence
           allows for the viewing of the thinking brain at rest, and looks at brain areas that are
           functionally working together at the same time. The brain is in one of its most active
           states when it is at rest, and literature has shown that a few neurological illnesses
           such as OCD, depression, and pain have been associated with analyzing the data in this
           sequence.

        2. Arterial Spin Labeling (ASL) - ASL tracks the blood flow in the brain visually and gives
           a statistical value of how much blood is in each region in cc's per 100 grams of brain
           per second.

        3. Diffusion Tensor Imaging (DTI) - DTI tractography shows the different fiber tracts in
           the brain using a 3D model. Fiber tracts are the physical neural pathways that can show
           disruption or connection in communication between different areas of the brain. This is
           an effective technique when looking at traumatic brain injury.

        4. Magnetic Resonance Spectroscopy (MRS) - MRS measures the ratios of select chemical
           compounds in the brain in relation to each other. This has shown to be effective in
           analyzing memory loss, dementia, and Alzheimer's type disorders.

        5. Stimulated BOLD - The same sequence as the resting BOLD, except the brain is being
           scanned during the completion of a task, instead of rest. By specifying the task
           (visual, problem solving, language, etc.), the different areas of the brain working
           together to complete this task can be imaged. This is very effective for task-specific
           symptoms and deficits.

      The methods and procedures in this study are all under the observational category. MRI's are
      FDA approved and are non-experimental devices. The goal of this research is to assess the
      feasibility of the scan itself, so everything done with respect to the scan is considered
      observational in nature. If the subject drops out of the study, anything described in this
      protocol will still be able available to the subject as standard medical care. The
      observational procedures will involve recording data for the advanced MRI scans, and no
      information will be shared for research if the subject does not sign the consent form.
observational model: Case-Only
time perspective: Prospective
measure: Number of subjects who successfully complete an fMRI scan
time frame: Through study completion, an average of 1 year
description: In order to assess scan feasibility, we will keep track of the total number of patients who sign the consent form and are able to complete the fMRI scan.
measure: Subject appointment time vs. subject arrival time
time frame: Through study completion, an average of 1 year
description: For each study subject, we will record the scheduled fMRI appointment time vs. the time that the subject arrives.
measure: Time it takes subject to get from checked-in to start of scan (in minutes)
time frame: Through study completion, an average of 1 year
description: For each study subject, we will record how long it takes to transition the subject from check-in to starting the fMRI scan.
measure: How long was the scanner unoccupied (in minutes)
time frame: Through study completion, an average of 1 year
description: We will record the length of time that the scanner is unoccupied in between scans.
measure: Number and type of sequences performed
time frame: Through study completion, an average of 1 year
description: For each study subject, we will record the number and type of sequences performed for the fMRI scan, e.g. MPRAGE, ASL, Resting BOLD, etc.
measure: Time of scan (in minutes)
time frame: Through study completion, an average of 1 year
description: For each study subject, we will record the total amount of time it takes to complete the fMRI scan.
measure: How many times did the subject pause the scan (if any) and for how long (in minutes)
time frame: Through study completion, an average of 1 year
description: For each study subject, we will record the number of times a subject pauses the fMRI scan and the duration of each pause.
measure: Did the subject finish the scan
time frame: Through study completion, an average of 1 year
description: For each study subject, we will record whether or not the subject was able to complete the fMRI scan.
measure: Did the subject cancel the scan, and for what reason
time frame: Through study completion, an average of 1 year
description: For each study subject, we will record whether the patient canceled the fMRI scan and for what reason.
measure: Did the subject cause too much movement artifact
time frame: Through study completion, an average of 1 year
description: For each study subject, we will record whether the post-processed fMRI data shows too much motion artifact, which could lead to the subject needing to be re-scanned.
measure: Does the subject need to be re-scanned, and for what reason
time frame: Through study completion, an average of 1 year
description: For each study subject, we will record whether or not the subject requires a re-scan and for what reason.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Sheldon Jordan, MD, FAAN
role: Principal Investigator
affiliation: Neurological Associates of West Los Angeles
last name: Sheldon Jordan, MD, FAAN
phone: 3108295968
email: shellyj@aol.com
last name: Robin Blades, BA
phone: 3108295968
phone ext: 214
email: rblades@theneuroassociates.com
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Neurological Associates of West Los Angeles
investigator full name: Sheldon Jordan
investigator title: Neurologist
mesh term: Neurodevelopmental Disorders
sharing ipd: No