<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/NCT03288909</url>
  </required_header>
  <id_info>
    <org_study_id>eIRB#5611</org_study_id>
    <nct_id>NCT03288909</nct_id>
  </id_info>
  <brief_title>Ultra High Field Magnetic Resonance Imaging as a Biomarker for Premotor Parkinson's Disease</brief_title>
  <official_title>Ultra High Field Magnetic Resonance Imaging as a Biomarker for Premotor Parkinson's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oregon Health and Science University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oregon Health and Science University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective observational study investigating the utility of 7 Tesla MRI to&#xD;
      quantify nigrosome1 signal in a cohort of individuals with recent onset Parkinson's disease&#xD;
      and in at-risk cohorts at a premotor state of Parkinson's disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2015</start_date>
  <completion_date type="Anticipated">January 2021</completion_date>
  <primary_completion_date type="Anticipated">January 2020</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>Quantitative signal analysis of nigrosome 1</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in quantitative signal analysis of nigrosome 1</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">18</enrollment>
  <condition>Parkinson Disease</condition>
  <condition>REM Sleep Behavior Disorder</condition>
  <arm_group>
    <arm_group_label>Early onset Parkinson's disease</arm_group_label>
    <description>Idiopathic Parkinson's disease within 1 year of symptom onset</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Idiopathic REM Sleep Behavior Disorder</arm_group_label>
    <description>Idiopathic REM Sleep Behavior Disorder</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Age-matched healthy controls</arm_group_label>
    <description>Age-matched healthy controls</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MRI</intervention_name>
    <arm_group_label>Age-matched healthy controls</arm_group_label>
    <arm_group_label>Early onset Parkinson's disease</arm_group_label>
    <arm_group_label>Idiopathic REM Sleep Behavior Disorder</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Idiopathic Parkinson's disease within 1 year of motor symptom onset. Idiopathic REM sleep&#xD;
        behavior disorder without signs/symptoms of Parkinson's disease.&#xD;
&#xD;
        Age-matched controls.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Idiopathic Parkinson's disease within 1 year of motor symptom onset. Idiopathic REM&#xD;
             sleep behavior disorder without signs/symptoms of Parkinson's disease.&#xD;
&#xD;
        Age-matched controls.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Atypical Parkinsonism&#xD;
&#xD;
          -  Contraindications for MRI&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Matthew Brodsky, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oregon Health and Science University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Matthew Brodsky, MD</last_name>
    <phone>5034949054</phone>
    <email>brodskym@ohsu.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Oregon Health &amp; Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Matthew Brodsky, MD</last_name>
      <phone>503-494-7231</phone>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 20, 2017</study_first_posted>
  <last_update_submitted>June 20, 2019</last_update_submitted>
  <last_update_submitted_qc>June 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oregon Health and Science University</investigator_affiliation>
    <investigator_full_name>Matthew Brodsky</investigator_full_name>
    <investigator_title>Associate Professor of Neurology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
    <mesh_term>REM Sleep Behavior Disorder</mesh_term>
    <mesh_term>Mental Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03288909
org study id: eIRB#5611
nct id: NCT03288909
lead sponsor: 
has dmc: No
This is a prospective observational study investigating the utility of 7 Tesla MRI to
      quantify nigrosome1 signal in a cohort of individuals with recent onset Parkinson's disease
      and in at-risk cohorts at a premotor state of Parkinson's disease.
observational model: Case-Control
time perspective: Prospective
measure: Quantitative signal analysis of nigrosome 1
time frame: 1 year
measure: Change in quantitative signal analysis of nigrosome 1
time frame: 3 years
arm group label: Early onset Parkinson's disease
description: Idiopathic Parkinson's disease within 1 year of symptom onset
arm group label: Idiopathic REM Sleep Behavior Disorder
description: Idiopathic REM Sleep Behavior Disorder
arm group label: Age-matched healthy controls
description: Age-matched healthy controls
intervention type: Other
intervention name: MRI
arm group label: Age-matched healthy controls
arm group label: Early onset Parkinson's disease
arm group label: Idiopathic REM Sleep Behavior Disorder
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Matthew Brodsky, MD
role: Principal Investigator
affiliation: Oregon Health and Science University
last name: Matthew Brodsky, MD
phone: 5034949054
email: brodskym@ohsu.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Oregon Health and Science University
investigator full name: Matthew Brodsky
investigator title: Associate Professor of Neurology
mesh term: Parkinson Disease
mesh term: REM Sleep Behavior Disorder
mesh term: Mental Disorders
sharing ipd: Undecided