xml: <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/NCT05972759</url>
    </required_header>
    <id_info>
      <org_study_id>22-568</org_study_id>
      <nct_id>NCT05972759</nct_id>
    </id_info>
    <brief_title>Identifying the Neural Signature of Exercise to Advance Treatment of PD Cognitive Declines</brief_title>
    <official_title>Identifying the Neural Signature of Exercise to Advance Treatment of PD Cognitive Declines</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The Cleveland Clinic</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>United States Department of Defense</agency>
        <agency_class>U.S. Fed</agency_class>
      </collaborator>
    </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>
        Twenty-five participants with PD utilizing the Medtronic Percept PC DBS system will be&#xD;
        enrolled for this project and complete a single bout of both FE and VE. The 150-minute&#xD;
        experimental session will be completed in the OFF antiparkinsonian and Off-DBS state.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Parkinson's disease (PD) is a progressive neurological disease, most prevalent in older&#xD;
        adults, estimated to affect over 12 million people world-wide by 2040. Traditionally&#xD;
        considered a motor disorder, the impact of PD on cognitive performance is now widely accepted&#xD;
        with 80% of PD patients developing executive function impairments. Typical PD related&#xD;
        cognitive effects include impaired information processing, set-switching, working memory and&#xD;
        dual-tasking. While antiparkinsonian medication and deep brain simulation (DBS) are effective&#xD;
        in managing disease symptoms, disease modification has remained elusive. Exercise has been&#xD;
        proposed as the Universal Prescription for PD capable of slowing disease progression;&#xD;
        stationary cycling in particular has been suggested as an ideal exercise modality for people&#xD;
        with PD (PwPD). The investigator's seminal tandem cycling study was the first to utilize&#xD;
        forced exercise (FE) in human PD patients and demonstrated a 30% improvement in clinical&#xD;
        ratings compared to voluntary exercise (VE). Briefly, FE is a mode of high intensity exercise&#xD;
        originating in animal models of PD in which voluntary exercise rate is augmented, but not&#xD;
        replaced. Thus, PwPD were assisted in pedaling at a higher rate (cadence) on the tandem cycle&#xD;
        compared to those on a standard stationary cycle performing voluntary exercise (VE). This&#xD;
        work resulted in a paradigm shift in terms of recommending high intensity exercise for PwPD.&#xD;
        Despite the potential of exercise to alter disease progression, its mechanism of action and&#xD;
        effects on basal ganglia function are not understood.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 15, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2025</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>
      <intervention_model_description>Twenty-five participants with PD utilizing the Medtronic Percept PC DBS system will be enrolled for this project and completed a single bout of both FE and VE.</intervention_model_description>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Local Field Potentials during Cognitive Testing</measure>
      <time_frame>an average of 3 total days</time_frame>
      <description>Change in power in frequency bands of interest</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Trail Making Test A &amp; B</measure>
      <time_frame>an average of 3 total days</time_frame>
      <description>Change in neuropsychological tests designed to evaluate set-switching and attention</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Information Processing</measure>
      <time_frame>an average of 3 total days</time_frame>
      <description>Change in mobile application of simple and choice reaction time</description>
    </primary_outcome>
    <primary_outcome>
      <measure>N-Back Test</measure>
      <time_frame>an average of 3 total days</time_frame>
      <description>Change in working memory test of word recall</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Force-tracking with n-back</measure>
      <time_frame>an average of 3 total days</time_frame>
      <description>Change in upper extremity motor control assessment with cognitive component</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">25</enrollment>
    <condition>Parkinson Disease</condition>
    <arm_group>
      <arm_group_label>Experimental Arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Two modes of high intensity exercise.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Forced and voluntary exercise</intervention_name>
      <description>Twenty-five participants with PD utilizing the Medtronic Percept PC DBS system will be enrolled for this project and complete a single bout of both FE and VE. The 150-minute experimental session will be completed in the OFF antiparkinsonian and Off-DBS state.</description>
      <arm_group_label>Experimental Arm</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult with a diagnosis of PD by a movement disorders neurologist&#xD;
  &#xD;
            -  Previous placement, at least six months, of bilateral Medtronic Precept DBS as&#xD;
               standard of care treatment for their PD.&#xD;
  &#xD;
            -  Stable and clinically optimized DBS parameters for three months prior to enrollment.&#xD;
  &#xD;
            -  Demonstrate the ability to safely mount and dismount a recumbent exercise cycle with&#xD;
               an upright back.&#xD;
  &#xD;
            -  Willingness to withhold antiparkinsonian medication and DBS stimulation.&#xD;
  &#xD;
            -  Exercise clearance using the American College of Sports Medicine (ACSM)&#xD;
               Pre-participation Health Screen: a. If the ACSM screen recommends medical clearance,&#xD;
               the subject must obtain medical clearance by their health care provider prior to&#xD;
               participation; b. Those who choose not to obtain physician clearance will not be&#xD;
               eligible for participation.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Diagnosis of dementia or any neurocognitive impairment that compromises the ability to&#xD;
               provide informed consent.&#xD;
  &#xD;
            -  A musculoskeletal issue that limits one's ability to cycle&#xD;
  &#xD;
            -  Neurological disease other than Parkinson's disease (i.e. multiple sclerosis, stroke)&#xD;
               that impacts motor or cognitive function&#xD;
  &#xD;
            -  Uncontrolled cardiovascular risk factor such as a current cardiac arrhythmia,&#xD;
               uncontrolled hypertension, untreated deep vein thrombosis, etc.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>MacKenzie Dunlap, BS</last_name>
      <phone>216-219-3949</phone>
      <email>dunlapm4@ccf.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Elizabeth Jansen, MPH</last_name>
      <phone>216-445-3866</phone>
      <email>aej26@case.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Cleveland Clinic</name>
        <address>
          <city>Cleveland</city>
          <state>Ohio</state>
          <zip>44195</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>MacKenzie Dunlap</last_name>
        <phone>216-219-3949</phone>
        <email>dunlapm4@ccf.org</email>
      </contact>
      <investigator>
        <last_name>Jay Alberts, Ph.D.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Cleveland Clinic</name>
        <address>
          <city>Cleveland</city>
          <state>Ohio</state>
          <zip>44195</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Elizabeth A Jansen, MPH</last_name>
        <phone>216-445-3866</phone>
        <email>jansena@ccf.org</email>
      </contact>
      <contact_backup>
        <last_name>Anson B Rosenfeldt, DPT</last_name>
        <phone>216-445-3277</phone>
        <email>rosenfa2@ccf.org</email>
      </contact_backup>
      <investigator>
        <last_name>Jay L Alberts, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>The Cleveland Clinic</investigator_affiliation>
      <investigator_full_name>Jay Alberts</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Deep Brain Stimulation</keyword>
    <keyword>DBS</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Parkinson Disease</mesh_term>
      <mesh_term>Cognitive Dysfunction</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05972759
  org study id: 22-568
  nct id: NCT05972759
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Twenty-five participants with PD utilizing the Medtronic Percept PC DBS system will be
        enrolled for this project and complete a single bout of both FE and VE. The 150-minute
        experimental session will be completed in the OFF antiparkinsonian and Off-DBS state.
  Parkinson's disease (PD) is a progressive neurological disease, most prevalent in older
        adults, estimated to affect over 12 million people world-wide by 2040. Traditionally
        considered a motor disorder, the impact of PD on cognitive performance is now widely accepted
        with 80% of PD patients developing executive function impairments. Typical PD related
        cognitive effects include impaired information processing, set-switching, working memory and
        dual-tasking. While antiparkinsonian medication and deep brain simulation (DBS) are effective
        in managing disease symptoms, disease modification has remained elusive. Exercise has been
        proposed as the Universal Prescription for PD capable of slowing disease progression;
        stationary cycling in particular has been suggested as an ideal exercise modality for people
        with PD (PwPD). The investigator's seminal tandem cycling study was the first to utilize
        forced exercise (FE) in human PD patients and demonstrated a 30% improvement in clinical
        ratings compared to voluntary exercise (VE). Briefly, FE is a mode of high intensity exercise
        originating in animal models of PD in which voluntary exercise rate is augmented, but not
        replaced. Thus, PwPD were assisted in pedaling at a higher rate (cadence) on the tandem cycle
        compared to those on a standard stationary cycle performing voluntary exercise (VE). This
        work resulted in a paradigm shift in terms of recommending high intensity exercise for PwPD.
        Despite the potential of exercise to alter disease progression, its mechanism of action and
        effects on basal ganglia function are not understood.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Twenty-five participants with PD utilizing the Medtronic Percept PC DBS system will be enrolled for this project and completed a single bout of both FE and VE.
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Local Field Potentials during Cognitive Testing
  time frame: an average of 3 total days
  description: Change in power in frequency bands of interest
  measure: Trail Making Test A & B
  time frame: an average of 3 total days
  description: Change in neuropsychological tests designed to evaluate set-switching and attention
  measure: Information Processing
  time frame: an average of 3 total days
  description: Change in mobile application of simple and choice reaction time
  measure: N-Back Test
  time frame: an average of 3 total days
  description: Change in working memory test of word recall
  measure: Force-tracking with n-back
  time frame: an average of 3 total days
  description: Change in upper extremity motor control assessment with cognitive component
  arm group label: Experimental Arm
  arm group type: Experimental
  description: Two modes of high intensity exercise.
  intervention type: Other
  intervention name: Forced and voluntary exercise
  description: Twenty-five participants with PD utilizing the Medtronic Percept PC DBS system will be enrolled for this project and complete a single bout of both FE and VE. The 150-minute experimental session will be completed in the OFF antiparkinsonian and Off-DBS state.
  arm group label: Experimental Arm
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: MacKenzie Dunlap, BS
  phone: 216-219-3949
  email: dunlapm4@ccf.org
  last name: Elizabeth Jansen, MPH
  phone: 216-445-3866
  email: aej26@case.edu
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: The Cleveland Clinic
  investigator full name: Jay Alberts
  investigator title: Principal Investigator
  mesh term: Parkinson Disease
  mesh term: Cognitive Dysfunction