<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/NCT04428931</url>
  </required_header>
  <id_info>
    <org_study_id>200102</org_study_id>
    <secondary_id>20-N-0102</secondary_id>
    <nct_id>NCT04428931</nct_id>
  </id_info>
  <brief_title>Attentional Performance in Parkinson Disease</brief_title>
  <official_title>Evaluation of Attentional Performance in Parkinson Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institute of Neurological Disorders and Stroke (NINDS)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</source>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      Parkinson Disease (PD) is a nervous system disorder that affects movement. Dopamine is an&#xD;
      important neurotransmitter in the brain. As PD progresses, there is less and less dopamine in&#xD;
      the brain. Researchers think there may be a relationship between differences in attention and&#xD;
      dopamine in people with PD.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      To learn if people with PD that is worse on one side also have differences in how much&#xD;
      attention they pay to the two sides of space on their left and right.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      English-speaking, right-handed people age 35-80 with PD.&#xD;
&#xD;
      Design:&#xD;
&#xD;
      Participants will be screened with medical and neurological history and exam, and medicine&#xD;
      review.&#xD;
&#xD;
      Participants will have 1 study visit. It will last 7-8 hours. They will stop taking their&#xD;
      Parkinson medicine 12 hours before the visit.&#xD;
&#xD;
      Participants will complete questionnaires.&#xD;
&#xD;
      Participants will do tasks on a computer screen. They will judge the middle of lines, react&#xD;
      to stimuli, and search and identify items that appear on the screen.&#xD;
&#xD;
      Participants may have functional and structural magnetic resonance imaging (MRI). MRI uses a&#xD;
      strong magnetic field and radio waves to take pictures of the brain. During the MRI,&#xD;
      participants will lie on a table that slides in and out of the MRI scanner. While inside the&#xD;
      scanner, they will look at a cross on a screen, relax, and think about nothing.&#xD;
&#xD;
      Participants will undergo prism adaptation. They will sit in front of a board while their&#xD;
      chin rests on a support. They will point to 1 of 2 dots on the board while they wear prism&#xD;
      glasses that shift their vision to the left or right....&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Description:&#xD;
&#xD;
      We will investigate the relationship between Dopamine (DA) function and attention in patients&#xD;
      with asymmetric Parkinson Disease (PD). We hypothesize that the direction of asymmetry in&#xD;
      dopamine (DA) depletion predicts the asymmetry in visual attention.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      Primary Objective:&#xD;
&#xD;
      - to study attentional asymmetry in patients with PD. We hypothesize that visual attention in&#xD;
      Parkinson will be biased to the visual field contralateral to the least affected hemisphere&#xD;
      (i.e. contralateral to the most affected side).&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
        -  to investigate the correlation between feedback learning and visuospatial attention&#xD;
           performance in PD. We hypothesize that feedback learning will also be affected according&#xD;
           to the most compromised hemisphere. Right hemisphere-predominant PD patients (left-motor&#xD;
           predominant), compared to left hemisphere-predominant patients, will exhibit a rightward&#xD;
           visuospatial bias and a relative preference for learning from reward, compared to&#xD;
           punishment.&#xD;
&#xD;
        -  to investigate the effect of prism adaptation on feedback learning and visuospatial&#xD;
           attention in PD. This objective is exploratory.&#xD;
&#xD;
      Endpoints:&#xD;
&#xD;
      Primary Endpoint: visuospatial performance on the Landmark Task&#xD;
&#xD;
      Secondary Endpoints: performance on:&#xD;
&#xD;
        -  Posner Task&#xD;
&#xD;
        -  Visual Search Task&#xD;
&#xD;
        -  Attentional blink Task&#xD;
&#xD;
        -  Visuospatial performance on the Manual Line Bisection Task&#xD;
&#xD;
        -  Reward and Punishment Implicit Feedback Learning Task&#xD;
&#xD;
        -  The Attentional Scaling Task&#xD;
&#xD;
      Functional connectivity measured with resting state fMRI.&#xD;
&#xD;
      Study Population:&#xD;
&#xD;
      Sixty patients with asymmetric PD. Any gender, aged 35-80 (inclusive), able to give consent&#xD;
      and without a diagnosis of significant illness affecting the central nervous system other&#xD;
      than PD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    The pandemic caused a delay in starting the study; PI is leaving.&#xD;
  </why_stopped>
  <start_date type="Actual">December 6, 2021</start_date>
  <completion_date type="Actual">December 6, 2021</completion_date>
  <primary_completion_date type="Actual">December 6, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Attentional asymmetry</measure>
    <time_frame>2 months</time_frame>
    <description>Direction and degree of visuospatial bias on the Landmark task</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Feedback learning and visuospatial attention performance</measure>
    <time_frame>2 months</time_frame>
    <description>Direction and degree of visuospatial bias on the Manual Line Bisection, Visual Search Posner, Attentional Blink, Reward and Punishment Implicit Feedback Learning, and the Attentional Scaling Tasks</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Parkinson's Disease</condition>
  <arm_group>
    <arm_group_label>PD patients</arm_group_label>
    <description>Patients with Asymmetric Parkinson's disease</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Asymmetric PD patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        -  INCLUSION CRITERIA:&#xD;
&#xD;
               1. Provision of signed and dated informed consent form&#xD;
&#xD;
               2. Stated willingness to comply with all study procedures and availability for the&#xD;
                  duration of the study&#xD;
&#xD;
               3. Male or female aged 35 - 80 (inclusive)&#xD;
&#xD;
               4. Fluent in English&#xD;
&#xD;
               5. Right-handed per the Edinburgh Handedness scale&#xD;
&#xD;
               6. Able to provide consent&#xD;
&#xD;
               7. Diagnosis of idiopathic Parkinson s disease according to UK Brain Bank criteria&#xD;
&#xD;
               8. On dopaminergic therapy to treat Parkinsonian symptoms&#xD;
&#xD;
               9. MOCA Score greater than or equal to 24 determined by a NIH neurologist&#xD;
&#xD;
              10. Hoehn and Yahr Score less than or equal to 3 determined by a NIH neurologist&#xD;
&#xD;
              11. Asymmetric motor symptoms&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
          1. Any current major neurological or psychiatric disorder other than Parkinson s disease,&#xD;
             such as, (but not limited to) stroke, dementia, Alzheimer disease, Schizophrenia or&#xD;
             Major Depression Disorder&#xD;
&#xD;
          2. Inability to provide consent&#xD;
&#xD;
          3. Members of the Behavioral Neurology Unit, NINDS&#xD;
&#xD;
          4. Left-handed per the Edinburgh Handedness scale&#xD;
&#xD;
          5. Primarily axial motor symptoms or symmetrical limb involvement&#xD;
&#xD;
          6. Pregnancy&#xD;
&#xD;
          7. Exclusion criteria for MRI&#xD;
&#xD;
               -  Presence of metal which would make having an MRI scan unsafe, such as pacemakers,&#xD;
                  stimulators, pumps, aneurysm clips, metallic prostheses, artificial heart valves,&#xD;
                  cochlear implants or shrapnel fragments, or if subject was a welder or metal&#xD;
                  worker, since small metal fragments may be present in the eye.&#xD;
&#xD;
               -  Claustrophobia&#xD;
&#xD;
               -  Inability to lie supine comfortably for 1 hour&#xD;
&#xD;
               -  Pregnancy&#xD;
&#xD;
        INCLUSION OF VULNERABLE PARTICIPANTS:&#xD;
&#xD;
        Because the goals of the study can be accomplished without involving vulnerable population,&#xD;
        we will not include individuals without consent capacity.&#xD;
&#xD;
        Since the goal is to characterize visuospatial attention deficits in idiopathic PD which is&#xD;
        a disease of late adulthood, we will not include children.&#xD;
&#xD;
        The effects of MRI on fetal development and the health of pregnant women is unknown.&#xD;
&#xD;
        Therefore, women who are pregnant and breast-feeding will be excluded and women who can&#xD;
        become pregnant will be excluded following a positive pregnancy test, if the optional MRI&#xD;
        is under consideration.&#xD;
&#xD;
        The study requires fluency in English in order to completely understand tasks instructions,&#xD;
        thus non-English speakers/readers will be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eric M Wassermann, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Institute of Neurological Disorders and Stroke (NINDS)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Institutes of Health Clinical Center</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2020-N-0102.html</url>
    <description>NIH Clinical Center Detailed Web Page</description>
  </link>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>December 8, 2021</last_update_submitted>
  <last_update_submitted_qc>December 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 10, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Functional Connectivity</keyword>
  <keyword>Visual Attention</keyword>
  <keyword>Dopamine Depletion</keyword>
  <keyword>Landmark Test</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</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/NCT04428931
org study id: 200102
secondary id: 20-N-0102
nct id: NCT04428931
lead sponsor: 
Background:

      Parkinson Disease (PD) is a nervous system disorder that affects movement. Dopamine is an
      important neurotransmitter in the brain. As PD progresses, there is less and less dopamine in
      the brain. Researchers think there may be a relationship between differences in attention and
      dopamine in people with PD.

      Objective:

      To learn if people with PD that is worse on one side also have differences in how much
      attention they pay to the two sides of space on their left and right.

      Eligibility:

      English-speaking, right-handed people age 35-80 with PD.

      Design:

      Participants will be screened with medical and neurological history and exam, and medicine
      review.

      Participants will have 1 study visit. It will last 7-8 hours. They will stop taking their
      Parkinson medicine 12 hours before the visit.

      Participants will complete questionnaires.

      Participants will do tasks on a computer screen. They will judge the middle of lines, react
      to stimuli, and search and identify items that appear on the screen.

      Participants may have functional and structural magnetic resonance imaging (MRI). MRI uses a
      strong magnetic field and radio waves to take pictures of the brain. During the MRI,
      participants will lie on a table that slides in and out of the MRI scanner. While inside the
      scanner, they will look at a cross on a screen, relax, and think about nothing.

      Participants will undergo prism adaptation. They will sit in front of a board while their
      chin rests on a support. They will point to 1 of 2 dots on the board while they wear prism
      glasses that shift their vision to the left or right....
Study Description:

      We will investigate the relationship between Dopamine (DA) function and attention in patients
      with asymmetric Parkinson Disease (PD). We hypothesize that the direction of asymmetry in
      dopamine (DA) depletion predicts the asymmetry in visual attention.

      Objectives:

      Primary Objective:

      - to study attentional asymmetry in patients with PD. We hypothesize that visual attention in
      Parkinson will be biased to the visual field contralateral to the least affected hemisphere
      (i.e. contralateral to the most affected side).

      Secondary Objectives:

        -  to investigate the correlation between feedback learning and visuospatial attention
           performance in PD. We hypothesize that feedback learning will also be affected according
           to the most compromised hemisphere. Right hemisphere-predominant PD patients (left-motor
           predominant), compared to left hemisphere-predominant patients, will exhibit a rightward
           visuospatial bias and a relative preference for learning from reward, compared to
           punishment.

        -  to investigate the effect of prism adaptation on feedback learning and visuospatial
           attention in PD. This objective is exploratory.

      Endpoints:

      Primary Endpoint: visuospatial performance on the Landmark Task

      Secondary Endpoints: performance on:

        -  Posner Task

        -  Visual Search Task

        -  Attentional blink Task

        -  Visuospatial performance on the Manual Line Bisection Task

        -  Reward and Punishment Implicit Feedback Learning Task

        -  The Attentional Scaling Task

      Functional connectivity measured with resting state fMRI.

      Study Population:

      Sixty patients with asymmetric PD. Any gender, aged 35-80 (inclusive), able to give consent
      and without a diagnosis of significant illness affecting the central nervous system other
      than PD.
observational model: Cohort
time perspective: Prospective
measure: Attentional asymmetry
time frame: 2 months
description: Direction and degree of visuospatial bias on the Landmark task
measure: Feedback learning and visuospatial attention performance
time frame: 2 months
description: Direction and degree of visuospatial bias on the Manual Line Bisection, Visual Search Posner, Attentional Blink, Reward and Punishment Implicit Feedback Learning, and the Attentional Scaling Tasks
arm group label: PD patients
description: Patients with Asymmetric Parkinson's disease
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 35 Years
maximum age: 80 Years
healthy volunteers: No
last name: Eric M Wassermann, M.D.
role: Principal Investigator
affiliation: National Institute of Neurological Disorders and Stroke (NINDS)
facility: 
country: United States
url: https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2020-N-0102.html
description: NIH Clinical Center Detailed Web Page
responsible party type: Sponsor
mesh term: Parkinson Disease