<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/NCT02261649</url>
  </required_header>
  <id_info>
    <org_study_id>14-104</org_study_id>
    <secondary_id>1R21CA185870-01</secondary_id>
    <nct_id>NCT02261649</nct_id>
  </id_info>
  <brief_title>Impact of Cerebellar Mass Resection on Pain Processing</brief_title>
  <official_title>The Impact of Cerebellar Mass Resection on Pain Processing</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dana-Farber Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Dana-Farber Cancer Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to evaluate how cerebellar resection surgery may affect pain&#xD;
      sensation and the way the brain &quot;reads&quot; pain signals. By measuring brain activity in children&#xD;
      and adolescents following surgery, the investigators hope to gain valuable information about&#xD;
      pain processing in the brain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is designed to test whether cerebellar resection surgery affects pain pathways in&#xD;
      the brain. To participate a participant must (A) have had a cerebellar mass surgically&#xD;
      removed, or (B) are a healthy volunteer with no history of pain disorders or mental illness.&#xD;
      The study will involve sensory testing and brain imaging using magnetic resonance imaging&#xD;
      (MRI) Sensory testing will be performed using a tub of cold water, as well as a contact&#xD;
      thermode capable of delivering hot and cold temperatures. MRI brain scanning uses magnetic&#xD;
      fields and radio waves to give pictures of the brain without using radiation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">April 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Increase in blood oxygen level dependent signal response</measure>
    <time_frame>Baseline, Day 1</time_frame>
    <description>Functional magnetic resonance imaging scans will be collected to measure blood oxygen level dependent (BOLD) responses, an indirect measure measure of neural activity. The Unit of Measure is % BOLD signal change across spatiotemporal domains within the brain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fear of Pain Questionnaire-Child scores</measure>
    <time_frame>Baseline, Day 1</time_frame>
    <description>Assesses fear of pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Multidimensional Anxiety Scale for Children scores</measure>
    <time_frame>Baseline, Day 1</time_frame>
    <description>Assesses anxiety</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behavior Rating Inventory of Executive Function scores</measure>
    <time_frame>Baseline, Day 1</time_frame>
    <description>Assesses executive function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fear of Pain Questionnaire III-Adult scores</measure>
    <time_frame>Baseline, Day 1</time_frame>
    <description>Assesses fear of pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Multidimensional Anxiety Questionnaire-Adult scores</measure>
    <time_frame>Baseline, Day 1</time_frame>
    <description>Assesses anxiety</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behavior Rating Inventory of Executive Function-Adult version scores</measure>
    <time_frame>Baseline, Day 1</time_frame>
    <description>Assesses executive function</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">24</enrollment>
  <condition>Cerebellar Neoplasm</condition>
  <arm_group>
    <arm_group_label>Cerebellar Tumor Surgically Removed</arm_group_label>
    <description>Quantitative Sensory Testing and Neuroimaging&#xD;
Medoc Advanced Medical Systems PATHWAY Model ATS (Contact thermal stimulator)&#xD;
Cold water bath&#xD;
MRI scanner&#xD;
Questionnaires</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Volunteer</arm_group_label>
    <description>Quantitative Sensory Testing and Neuroimaging&#xD;
Medoc Advanced Medical Systems PATHWAY Model ATS (Contact thermal stimulator)&#xD;
Cold water bath&#xD;
MRI scanner&#xD;
Questionnaires</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Medoc Advanced Medical Systems PATHWAY Model ATS</intervention_name>
    <description>30 minutes of sensory testing using a contact thermal stimulator will measure thresholds for heat and cool detection, and threshold for hot and cold pain.</description>
    <arm_group_label>Cerebellar Tumor Surgically Removed</arm_group_label>
    <arm_group_label>Healthy Volunteer</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cold water bath</intervention_name>
    <description>The next 15 minutes of sensory testing will measure tolerance to having right or left hand in a tub of cold water. The participant will place their hand in cold water and leave it there for as long they can, even if it is uncomfortable. The participant can take their arm out if it gets too uncomfortable to leave it in.</description>
    <arm_group_label>Cerebellar Tumor Surgically Removed</arm_group_label>
    <arm_group_label>Healthy Volunteer</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MRI scanner</intervention_name>
    <description>An MRI will be used to collect anatomical and functional images from patients and subjects. These data will be collected within a 1 hour block.</description>
    <arm_group_label>Cerebellar Tumor Surgically Removed</arm_group_label>
    <arm_group_label>Healthy Volunteer</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaires</intervention_name>
    <description>The surveys include questions about emotions, thoughts, and feelings. These surveys will be given before sensory testing and before the MRI scan. The parent or guardian will help to complete two surveys, and will complete one survey on his or her own. Questions can be skipped, and may be stopped at any time.</description>
    <arm_group_label>Cerebellar Tumor Surgically Removed</arm_group_label>
    <arm_group_label>Healthy Volunteer</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with cerebellar resection and healthy volunteers.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria for patients:&#xD;
&#xD;
          -  Age 4-18 years old at the time of surgery&#xD;
&#xD;
          -  Resection limited to the cerebellum&#xD;
&#xD;
          -  Within 20 years of surgery&#xD;
&#xD;
          -  Good physical health excluding symptoms directly related to cerebellar resection&#xD;
&#xD;
          -  No cerebellar-mass directed treatment other than surgical resection&#xD;
&#xD;
        Inclusion Criteria for all subjects:&#xD;
&#xD;
          -  Age 6-38 years old at the time of participation&#xD;
&#xD;
          -  No paralysis/hemiparesis&#xD;
&#xD;
          -  No motor deficits that would interfere with performance or required tasks (button&#xD;
             press withdraw hand from water bath)&#xD;
&#xD;
          -  English speaking sufficient to comprehend and provide assent with parental assistance&#xD;
             or consent if over the age of 18&#xD;
&#xD;
          -  Ability to complete MRI without sedation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Claustrophobia&#xD;
&#xD;
          -  Significant medical (e.g. asthma, renal, cardiac, gastrointestinal or immunological)&#xD;
             or brain- related disorders (e.g. seizures, autism, psychiatric conditions such as&#xD;
             severe depression, psychosis)&#xD;
&#xD;
          -  Metallic or magnetic implants that pose a risk to the participant or to the data&#xD;
             quality&#xD;
&#xD;
          -  Weight &gt; 285 pounds (weight limit of the fMRI table)&#xD;
&#xD;
          -  History of drug abuse or positive drug screen&#xD;
&#xD;
          -  Positive pregnancy screen&#xD;
&#xD;
          -  Use of antidepressants or anticonvulsants, excepting patient usage after resection&#xD;
&#xD;
          -  Significant alcohol history (ingestion of 5 or more glasses (&gt; 40 oz) of alcohol per&#xD;
             week)&#xD;
&#xD;
          -  Tattoos containing metallic ink on the neck, shoulders, upper arm and head (which&#xD;
             could heat up in the scanner, and potentially cause blistering or burning)&#xD;
&#xD;
          -  Cardiac pacemakers&#xD;
&#xD;
          -  Aneurysm clips and other vascular stents, filters, clips or other devices&#xD;
&#xD;
          -  Prosthetic heart valves&#xD;
&#xD;
          -  Other prostheses&#xD;
&#xD;
          -  Neuro-stimulator devices&#xD;
&#xD;
          -  Implanted infusion pumps&#xD;
&#xD;
          -  Cochlear (ear) implants&#xD;
&#xD;
          -  Ocular (eye) implants or known metal fragments in eyes&#xD;
&#xD;
          -  Exposure to shrapnel or metal filings (sheet metal workers, welders, and others)&#xD;
&#xD;
          -  Participants that require anesthesia to complete an MRI scan&#xD;
&#xD;
          -  Receipt of a medication via transdermal patch&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>38 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eric Moulton, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston Children's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Boston Children's Hospital</name>
      <address>
        <city>Waltham</city>
        <state>Massachusetts</state>
        <zip>02453</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>October 2, 2014</study_first_submitted>
  <study_first_submitted_qc>October 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2014</study_first_posted>
  <last_update_submitted>January 30, 2018</last_update_submitted>
  <last_update_submitted_qc>January 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dana-Farber Cancer Institute</investigator_affiliation>
    <investigator_full_name>Eric Moulton, PhD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Cerebellar tumor</keyword>
  <keyword>Non-malignant low-grade cerebellar astrocytomas</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cerebellar Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT02261649
org study id: 14-104
secondary id: 1R21CA185870-01
nct id: NCT02261649
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of the study is to evaluate how cerebellar resection surgery may affect pain
      sensation and the way the brain "reads" pain signals. By measuring brain activity in children
      and adolescents following surgery, the investigators hope to gain valuable information about
      pain processing in the brain.
This study is designed to test whether cerebellar resection surgery affects pain pathways in
      the brain. To participate a participant must (A) have had a cerebellar mass surgically
      removed, or (B) are a healthy volunteer with no history of pain disorders or mental illness.
      The study will involve sensory testing and brain imaging using magnetic resonance imaging
      (MRI) Sensory testing will be performed using a tub of cold water, as well as a contact
      thermode capable of delivering hot and cold temperatures. MRI brain scanning uses magnetic
      fields and radio waves to give pictures of the brain without using radiation.
observational model: Case-Control
time perspective: Prospective
measure: Increase in blood oxygen level dependent signal response
time frame: Baseline, Day 1
description: Functional magnetic resonance imaging scans will be collected to measure blood oxygen level dependent (BOLD) responses, an indirect measure measure of neural activity. The Unit of Measure is % BOLD signal change across spatiotemporal domains within the brain.
measure: Fear of Pain Questionnaire-Child scores
time frame: Baseline, Day 1
description: Assesses fear of pain
measure: Multidimensional Anxiety Scale for Children scores
time frame: Baseline, Day 1
description: Assesses anxiety
measure: Behavior Rating Inventory of Executive Function scores
time frame: Baseline, Day 1
description: Assesses executive function
measure: Fear of Pain Questionnaire III-Adult scores
time frame: Baseline, Day 1
description: Assesses fear of pain
measure: Multidimensional Anxiety Questionnaire-Adult scores
time frame: Baseline, Day 1
description: Assesses anxiety
measure: Behavior Rating Inventory of Executive Function-Adult version scores
time frame: Baseline, Day 1
description: Assesses executive function
arm group label: Cerebellar Tumor Surgically Removed
description: Quantitative Sensory Testing and Neuroimaging
Medoc Advanced Medical Systems PATHWAY Model ATS (Contact thermal stimulator)
Cold water bath
MRI scanner
Questionnaires
arm group label: Healthy Volunteer
description: Quantitative Sensory Testing and Neuroimaging
Medoc Advanced Medical Systems PATHWAY Model ATS (Contact thermal stimulator)
Cold water bath
MRI scanner
Questionnaires
intervention type: Device
intervention name: Medoc Advanced Medical Systems PATHWAY Model ATS
description: 30 minutes of sensory testing using a contact thermal stimulator will measure thresholds for heat and cool detection, and threshold for hot and cold pain.
arm group label: Cerebellar Tumor Surgically Removed
arm group label: Healthy Volunteer
intervention type: Procedure
intervention name: Cold water bath
description: The next 15 minutes of sensory testing will measure tolerance to having right or left hand in a tub of cold water. The participant will place their hand in cold water and leave it there for as long they can, even if it is uncomfortable. The participant can take their arm out if it gets too uncomfortable to leave it in.
arm group label: Cerebellar Tumor Surgically Removed
arm group label: Healthy Volunteer
intervention type: Device
intervention name: MRI scanner
description: An MRI will be used to collect anatomical and functional images from patients and subjects. These data will be collected within a 1 hour block.
arm group label: Cerebellar Tumor Surgically Removed
arm group label: Healthy Volunteer
intervention type: Other
intervention name: Questionnaires
description: The surveys include questions about emotions, thoughts, and feelings. These surveys will be given before sensory testing and before the MRI scan. The parent or guardian will help to complete two surveys, and will complete one survey on his or her own. Questions can be skipped, and may be stopped at any time.
arm group label: Cerebellar Tumor Surgically Removed
arm group label: Healthy Volunteer
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 6 Years
maximum age: 38 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Eric Moulton, Ph.D
role: Principal Investigator
affiliation: Boston Children's Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Dana-Farber Cancer Institute
investigator full name: Eric Moulton, PhD
investigator title: Principal Investigator
mesh term: Cerebellar Neoplasms