<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/NCT03800108</url>
  </required_header>
  <id_info>
    <org_study_id>17-1350</org_study_id>
    <nct_id>NCT03800108</nct_id>
  </id_info>
  <brief_title>Stimulation Parameters and Non-motor Symptoms in PD Treated With DBS</brief_title>
  <acronym>FREQUENCY</acronym>
  <official_title>Stimulation Parameters and Non-motor Symptoms in PD Treated With DBS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Darlene Floden</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Cleveland Clinic</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>
      This study evaluates the role of subthalamic nucleus (STN) stimulation location and frequency&#xD;
      on a range of cognitive processes in Parkinson's patients who have undergone Deep Brain&#xD;
      Stimulation (DBS).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pre- and post- DBS implantation brain scans will be reviewed by the study team to see if&#xD;
      patients' DBS settings can be personalized. If so, study subjects will undergo adjustments to&#xD;
      their DBS settings and be asked to perform cognitive tests. Some patients will be asked to&#xD;
      come back for a second visit for brain scans.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">May 30, 2018</start_date>
  <completion_date type="Anticipated">September 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reaction time</measure>
    <time_frame>30-60 minutes after stimulation adjustment</time_frame>
    <description>Subjects will complete one or more measures of cognitive processing requiring speeded responses to stimuli. Changes in reaction time will be compared to 'off stimulation'</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Verbal Fluency</measure>
    <time_frame>30-60 minutes after stimulation adjustment</time_frame>
    <description>Change in the number words that patients generate to letter or semantic category cues will be compared to 'off stimulation'</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Finger tapping speed</measure>
    <time_frame>30-60 minutes after stimulation adjustment</time_frame>
    <description>Change in upper extremity speed (# of taps in 10 seconds) will be compared to 'off stimulation'</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">15</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>Personalized DBS adjustments</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Individualized stimulation adjustments based on pre- and post- DBS implantation MRIs</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Personalized DBS adjustments</intervention_name>
    <description>Individualized stimulation adjustments based on pre- and post- DBS implantation MRIs</description>
    <arm_group_label>Personalized DBS adjustments</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Between 40 and 70 years of age,&#xD;
&#xD;
          2. Ability to provide informed consent,&#xD;
&#xD;
          3. Clinical diagnosis of idiopathic Parkinson disease (PD) by a movement disorders&#xD;
             neurologist,&#xD;
&#xD;
          4. Disease duration of at least 4 years,&#xD;
&#xD;
          5. Treated with bilateral STN DBS for at least 3 months prior to study enrollment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of prior neurosurgical intervention for PD (e.g., DBS, thalamotomy,&#xD;
             pallidotomy)&#xD;
&#xD;
          2. History of other central nervous system disease (excluding migraine),&#xD;
&#xD;
          3. Presence of active psychiatric symptoms meeting Diagnostic and Statistical Manual of&#xD;
             Mental Disorders-4th Edition (DSM-IV) criteria for Axis-I disorder on formal&#xD;
             psychiatric evaluation, with the exception of mild depression (Beck Depression&#xD;
             Inventory-2 score below 19),&#xD;
&#xD;
          4. Cognitive impairment meeting Diagnostic and Statistical Manual of Mental Disorders-4th&#xD;
             Edition (DSM-IV) criteria for dementia on formal neuropsychological evaluation,&#xD;
&#xD;
          5. Current alcohol or substance abuse,&#xD;
&#xD;
          6. Lack of fluency in English which would invalidate cognitive testing,&#xD;
&#xD;
          7. Hearing or visual impairment precluding cognitive testing.&#xD;
&#xD;
             Exclusion criteria for Day 2 procedures:&#xD;
&#xD;
          8. Inability to safely undergo MRI procedure (i.e., metal objects like prostheses,&#xD;
             pacemakers)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Darlene Floden, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Cleveland Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>May 23, 2018</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>August 23, 2023</last_update_submitted>
  <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>The Cleveland Clinic</investigator_affiliation>
    <investigator_full_name>Darlene Floden</investigator_full_name>
    <investigator_title>Staff Neuropsychologist</investigator_title>
  </responsible_party>
  <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/NCT03800108
org study id: 17-1350
nct id: NCT03800108
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the role of subthalamic nucleus (STN) stimulation location and frequency
      on a range of cognitive processes in Parkinson's patients who have undergone Deep Brain
      Stimulation (DBS).
Pre- and post- DBS implantation brain scans will be reviewed by the study team to see if
      patients' DBS settings can be personalized. If so, study subjects will undergo adjustments to
      their DBS settings and be asked to perform cognitive tests. Some patients will be asked to
      come back for a second visit for brain scans.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Reaction time
time frame: 30-60 minutes after stimulation adjustment
description: Subjects will complete one or more measures of cognitive processing requiring speeded responses to stimuli. Changes in reaction time will be compared to 'off stimulation'
measure: Verbal Fluency
time frame: 30-60 minutes after stimulation adjustment
description: Change in the number words that patients generate to letter or semantic category cues will be compared to 'off stimulation'
measure: Finger tapping speed
time frame: 30-60 minutes after stimulation adjustment
description: Change in upper extremity speed (# of taps in 10 seconds) will be compared to 'off stimulation'
arm group label: Personalized DBS adjustments
arm group type: Other
description: Individualized stimulation adjustments based on pre- and post- DBS implantation MRIs
intervention type: Procedure
intervention name: Personalized DBS adjustments
description: Individualized stimulation adjustments based on pre- and post- DBS implantation MRIs
arm group label: Personalized DBS adjustments
criteria: 
gender: All
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: No
last name: Darlene Floden, PhD
role: Principal Investigator
affiliation: The Cleveland Clinic
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: The Cleveland Clinic
investigator full name: Darlene Floden
investigator title: Staff Neuropsychologist
mesh term: Parkinson Disease
sharing ipd: No