<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/NCT03241966</url>
  </required_header>
  <id_info>
    <org_study_id>1204E</org_study_id>
    <nct_id>NCT03241966</nct_id>
  </id_info>
  <brief_title>Perception, Cognition, and Gait in Parkinson's Disease</brief_title>
  <official_title>Perception, Cognition, and Gait in Parkinson's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston University Charles River Campus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston University Charles River Campus</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>
      The investigators are examining how aspects of daily function are perceived in persons with&#xD;
      PD and in those who interact with them on a regular basis. If eligible, participants will&#xD;
      receive a set of online questionnaires by email. The questionnaires will take about 1 hour to&#xD;
      complete, and can be done at the participant's convenience. The investigators are looking for&#xD;
      volunteers who have a diagnosis of Parkinson's disease without dementia (age 40 or older and&#xD;
      proficient English speakers). If a spouse, family member, significant other or other close&#xD;
      associate is available (age 18 or older, proficient English speakers), the investigators will&#xD;
      send them questionnaires as well. There is no monetary or other compensation for this study.&#xD;
      For more information, please contact the Vision and Cognition Laboratory at&#xD;
      vcognition@gmail.com or 617-358-1377.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2017</start_date>
  <completion_date type="Actual">January 15, 2019</completion_date>
  <primary_completion_date type="Actual">January 15, 2019</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Parkinson's Disease Questionnaire (PDQ-39)</measure>
    <time_frame>Within 24 hours of starting the study</time_frame>
    <description>Measures the health status of Parkinson's disease patients and the impact the disease has on their aspects of daily living. There are 39 items.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">439</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>People with Parkinson's Disease</arm_group_label>
    <description>Individuals diagnosed with idiopathic Parkinson's disease without dementia.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Informant</arm_group_label>
    <description>Family member, spouse, significant other, caregiver, or other close associate of someone with Parkinson's disease.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Participants are accepted regardless of location, community, clinic, etc.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with Parkinson's disease without dementia OR close associate of someone with&#xD;
             Parkinson's disease&#xD;
&#xD;
          -  40 years or older&#xD;
&#xD;
          -  Proficient English speaker&#xD;
&#xD;
          -  Access to a computer&#xD;
&#xD;
          -  8+ years of education&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Co-existing active neoplasm, serious cardiac disease, other serious chronic medical&#xD;
             illness&#xD;
&#xD;
          -  Prior intracranial surgery&#xD;
&#xD;
          -  History of traumatic brain injury&#xD;
&#xD;
          -  Psychiatric or neurological diagnoses other than Parkinson's disease&#xD;
&#xD;
          -  History of alcoholism or other drug abuse&#xD;
&#xD;
          -  History of treatment with electroshock therapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alice Cronin-Golomb, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vision and Cognition Laboratory at Boston University</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>August 4, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>February 9, 2021</last_update_submitted>
  <last_update_submitted_qc>February 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston University Charles River Campus</investigator_affiliation>
    <investigator_full_name>Alice Cronin-Golomb</investigator_full_name>
    <investigator_title>Director of Vision and Cognition Laboratory</investigator_title>
  </responsible_party>
  <keyword>Parkinson's Disease</keyword>
  <keyword>Online Study</keyword>
  <keyword>Quality of Life</keyword>
  <keyword>Activities of Daily Living</keyword>
  <keyword>Perception</keyword>
  <keyword>Cognition</keyword>
  <keyword>Gait</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</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/NCT03241966
org study id: 1204E
nct id: NCT03241966
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators are examining how aspects of daily function are perceived in persons with
      PD and in those who interact with them on a regular basis. If eligible, participants will
      receive a set of online questionnaires by email. The questionnaires will take about 1 hour to
      complete, and can be done at the participant's convenience. The investigators are looking for
      volunteers who have a diagnosis of Parkinson's disease without dementia (age 40 or older and
      proficient English speakers). If a spouse, family member, significant other or other close
      associate is available (age 18 or older, proficient English speakers), the investigators will
      send them questionnaires as well. There is no monetary or other compensation for this study.
      For more information, please contact the Vision and Cognition Laboratory at
      vcognition@gmail.com or 617-358-1377.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Parkinson's Disease Questionnaire (PDQ-39)
time frame: Within 24 hours of starting the study
description: Measures the health status of Parkinson's disease patients and the impact the disease has on their aspects of daily living. There are 39 items.
arm group label: People with Parkinson's Disease
description: Individuals diagnosed with idiopathic Parkinson's disease without dementia.
arm group label: Informant
description: Family member, spouse, significant other, caregiver, or other close associate of someone with Parkinson's disease.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Alice Cronin-Golomb, Ph.D.
role: Principal Investigator
affiliation: Boston University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Boston University Charles River Campus
investigator full name: Alice Cronin-Golomb
investigator title: Director of Vision and Cognition Laboratory
mesh term: Parkinson Disease
sharing ipd: No