<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/NCT04408573</url>
  </required_header>
  <id_info>
    <org_study_id>67914017.6.0000.0068</org_study_id>
    <nct_id>NCT04408573</nct_id>
  </id_info>
  <brief_title>Cycling Deep Brain Stimulation on Parkinson's Disease Gait</brief_title>
  <acronym>DBS</acronym>
  <official_title>Effects of Cycling Deep Brain Stimulation on Parkinson's Disease Gait</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo General Hospital</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>
      Our hypothesis is that cycling DBS stimulation would be superior or non-inferior to regular&#xD;
      DBS stimulation in Parkinson's disease patients with gait impairment. The objective of this&#xD;
      study is compare gait disorders in patients with Parkinson's disease and DBS in 4 different&#xD;
      scenarios: 1) regular continuous high frequency (&gt;130Hz) stimulation, 2) cycling high&#xD;
      frequency (&gt;130Hz) stimulation (40sec on, 2sec off), 3) low-frequency (80Hz) continuous&#xD;
      stimulation and 4) cycling low frequency (80Hz) stimulation (40sec on, 2sec off)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Gait disorders such as falls, freezing of gait, reduction of speed, shuffling, and&#xD;
      multi-stepped turning are common in patients with moderate and advanced Parkinson's disease.&#xD;
      Compared to appendicular symptoms (bradykinesia, tremor, and rigidity), gait disorders tend&#xD;
      to be more resistant to medical and regular deep brain stimulation treatment, and greatly&#xD;
      impairs patients' quality of life and daily living activities. Some stimulation strategies&#xD;
      have been tried to improve gait in Parkinson's disease patients, but so far most of them&#xD;
      resulted in concomitant worsening of appendicular symptoms. However, new stimulation&#xD;
      strategies such as cycling stimulation can potentially improve gait disorders without&#xD;
      impairment of appendicular symptoms.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 19, 2020</start_date>
  <completion_date type="Anticipated">December 29, 2021</completion_date>
  <primary_completion_date type="Anticipated">May 29, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>2 weeks of regular continuous high frequency (&gt;130Hz) stimulation, 2 weeks of cycling high frequency (&gt;130Hz) stimulation (40sec on, 2sec off), 2 weeks of low-frequency (80Hz) continuous stimulation and 2 weeks of cycling low frequency (80Hz) stimulation (40sec on, 2sec off)</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the part II of the Unified Parkinson's disease rating scale</measure>
    <time_frame>Baseline + after 2 weeks + after 4 weeks + after 6 weeks</time_frame>
    <description>The part II of the Unified Parkinson's disease rating scale (UPDRS II) is a self-reportable questionnaire consisting of 13 items that measure functionality (motor experiences of daily living). Scores vary from 0 - 52. Higher scores mean a worse outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the New Freezing of Gait Questionnaire</measure>
    <time_frame>Baseline + after 2 weeks + after 4 weeks + after 6 weeks</time_frame>
    <description>The New Freezing of Gait Questionnaire (NFOG-Q) is a self-reportable questionnaire consisting of 9 items that measure freezing of gait (FOG). Scores vary from 0 - 28. Higher scores mean a worse outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Falls Efficacy Scale</measure>
    <time_frame>Baseline + after 2 weeks + after 4 weeks + after 6 weeks</time_frame>
    <description>The Falls Efficacy Scale (FES) is a sixteen-item test rated on a 10-point scale from not confident at all to completely confident. It is correlated with difficulty getting up from a fall and level of anxiety. Scores vary from 16 - 64. Higher scores mean a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in The Parkinson's Disease Questionnaire (PDQ-39)</measure>
    <time_frame>Baseline + after 2 weeks + after 4 weeks + after 6 weeks</time_frame>
    <description>This questionnaire assesses how often people affected by Parkinson's experience difficulties across 8 dimensions of daily living. The 39 item questionnaire offers a patient reported measure of health status and quality of life and is the most frequently used disease-specific health status measure.Scores vary from 0 - 156. Higher scores mean a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Activities-Specific Balance Confidence Scale (ABC scale)</measure>
    <time_frame>Baseline + after 2 weeks + after 4 weeks + after 6 weeks</time_frame>
    <description>The ABC scale is a self-report measure of balance in performing various activities without losing balance or experiencing a sense of unsteadiness. Scores vary from 0 - 100. Higher scores mean a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of falls</measure>
    <time_frame>Baseline + after 2 weeks + after 4 weeks + after 6 weeks</time_frame>
    <description>Patients will be questioned about number of times they experienced falls in the last 2 weeks. Higher numbers mean a worse outcome.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>Regular Continuous High Frequency</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patient remains 2 weeks in the currently chosen stimulation protocol.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cycling High Frequency</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient is stimulated with the same polarity, voltage/current, pulse width and frequency as the currently chosen stimulation protocol, but with cycling stimulation: 40sec On - 02 sec OFF</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Continuous Low Frequency</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient is stimulated with the same polarity and pulse width as the currently chosen stimulation protocol, but with low frequency (80Hz). Voltage/current will be adjusted to maintain TEED similar to that on the regular stimulation protocol.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cycling Low Frequency</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient is stimulated with the same polarity and pulse width as the currently chosen stimulation protocol, but with low frequency (80Hz) and cycling stimulation: 40sec On - 02 sec OFF. Voltage/current will be adjusted to maintain TEED similar to that on the regular stimulation protocol.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cycling deep brain stimulation</intervention_name>
    <description>Deep Brain Stimulation applied in cycling - periods of stimulation ON intercalated with periods of stimulation OFF</description>
    <arm_group_label>Continuous Low Frequency</arm_group_label>
    <arm_group_label>Cycling High Frequency</arm_group_label>
    <arm_group_label>Cycling Low Frequency</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of idiopathic Parkinson's disease&#xD;
&#xD;
          -  Currently receiving Deep Brain Stimulation as a Parkinson's disease treatment&#xD;
&#xD;
          -  Hoehn &amp; Yahr stage between 2-4 during off-medication&#xD;
&#xD;
          -  Underlying gait disorders despite optimal medical and stimulation treatment: score&#xD;
             over or equal to 1 in the subitem 2.12 of the MDS-UPDRS scale&#xD;
&#xD;
          -  Willingness to comply with all study procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active moderate/severe psychiatric condition&#xD;
&#xD;
          -  Active infection or other uncontrolled moderate/grave comorbidities&#xD;
&#xD;
          -  Treatment with experimental drug&#xD;
&#xD;
          -  Pregnancy or breast-feeding&#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_official>
    <last_name>Rubens G Cury, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Sao Paulo General Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Rubens G Cury, MD, PhD</last_name>
    <phone>55 11 26617877</phone>
    <email>rubens_cury@usp.br</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Carina C França, MD</last_name>
    <phone>55 11 26617877</phone>
    <email>carina.fr@usp.br</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hospital das Clínicas da Faculdade de Medicina da USP</name>
      <address>
        <city>São Paulo</city>
        <state>SP</state>
        <zip>05403000</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rubens G Cury, MD PhD</last_name>
      <phone>55 11 26617877</phone>
      <email>rubens_cury@usp.br</email>
    </contact>
    <investigator>
      <last_name>Carina C França, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 25, 2020</study_first_submitted>
  <study_first_submitted_qc>May 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>June 19, 2020</last_update_submitted>
  <last_update_submitted_qc>June 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo General Hospital</investigator_affiliation>
    <investigator_full_name>Rubens Gisbert Cury</investigator_full_name>
    <investigator_title>Principal Investigator</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>Yes</sharing_ipd>
    <ipd_description>all IPD that underlie results in a publication</ipd_description>
    <ipd_time_frame>Data will be made available indefinitely upon reasonable request from other authors</ipd_time_frame>
    <ipd_access_criteria>Investigator Rubens Cury will analyse request and decide upon reasonability</ipd_access_criteria>
  </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/NCT04408573
org study id: 67914017.6.0000.0068
nct id: NCT04408573
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Our hypothesis is that cycling DBS stimulation would be superior or non-inferior to regular
      DBS stimulation in Parkinson's disease patients with gait impairment. The objective of this
      study is compare gait disorders in patients with Parkinson's disease and DBS in 4 different
      scenarios: 1) regular continuous high frequency (>130Hz) stimulation, 2) cycling high
      frequency (>130Hz) stimulation (40sec on, 2sec off), 3) low-frequency (80Hz) continuous
      stimulation and 4) cycling low frequency (80Hz) stimulation (40sec on, 2sec off)
Gait disorders such as falls, freezing of gait, reduction of speed, shuffling, and
      multi-stepped turning are common in patients with moderate and advanced Parkinson's disease.
      Compared to appendicular symptoms (bradykinesia, tremor, and rigidity), gait disorders tend
      to be more resistant to medical and regular deep brain stimulation treatment, and greatly
      impairs patients' quality of life and daily living activities. Some stimulation strategies
      have been tried to improve gait in Parkinson's disease patients, but so far most of them
      resulted in concomitant worsening of appendicular symptoms. However, new stimulation
      strategies such as cycling stimulation can potentially improve gait disorders without
      impairment of appendicular symptoms.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: 2 weeks of regular continuous high frequency (>130Hz) stimulation, 2 weeks of cycling high frequency (>130Hz) stimulation (40sec on, 2sec off), 2 weeks of low-frequency (80Hz) continuous stimulation and 2 weeks of cycling low frequency (80Hz) stimulation (40sec on, 2sec off)
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Change in the part II of the Unified Parkinson's disease rating scale
time frame: Baseline + after 2 weeks + after 4 weeks + after 6 weeks
description: The part II of the Unified Parkinson's disease rating scale (UPDRS II) is a self-reportable questionnaire consisting of 13 items that measure functionality (motor experiences of daily living). Scores vary from 0 - 52. Higher scores mean a worse outcome.
measure: Change in the New Freezing of Gait Questionnaire
time frame: Baseline + after 2 weeks + after 4 weeks + after 6 weeks
description: The New Freezing of Gait Questionnaire (NFOG-Q) is a self-reportable questionnaire consisting of 9 items that measure freezing of gait (FOG). Scores vary from 0 - 28. Higher scores mean a worse outcome.
measure: Change in Falls Efficacy Scale
time frame: Baseline + after 2 weeks + after 4 weeks + after 6 weeks
description: The Falls Efficacy Scale (FES) is a sixteen-item test rated on a 10-point scale from not confident at all to completely confident. It is correlated with difficulty getting up from a fall and level of anxiety. Scores vary from 16 - 64. Higher scores mean a worse outcome.
measure: Change in The Parkinson's Disease Questionnaire (PDQ-39)
time frame: Baseline + after 2 weeks + after 4 weeks + after 6 weeks
description: This questionnaire assesses how often people affected by Parkinson's experience difficulties across 8 dimensions of daily living. The 39 item questionnaire offers a patient reported measure of health status and quality of life and is the most frequently used disease-specific health status measure.Scores vary from 0 - 156. Higher scores mean a worse outcome.
measure: Change in Activities-Specific Balance Confidence Scale (ABC scale)
time frame: Baseline + after 2 weeks + after 4 weeks + after 6 weeks
description: The ABC scale is a self-report measure of balance in performing various activities without losing balance or experiencing a sense of unsteadiness. Scores vary from 0 - 100. Higher scores mean a better outcome.
measure: Number of falls
time frame: Baseline + after 2 weeks + after 4 weeks + after 6 weeks
description: Patients will be questioned about number of times they experienced falls in the last 2 weeks. Higher numbers mean a worse outcome.
arm group label: Regular Continuous High Frequency
arm group type: No Intervention
description: Patient remains 2 weeks in the currently chosen stimulation protocol.
arm group label: Cycling High Frequency
arm group type: Experimental
description: Patient is stimulated with the same polarity, voltage/current, pulse width and frequency as the currently chosen stimulation protocol, but with cycling stimulation: 40sec On - 02 sec OFF
arm group label: Continuous Low Frequency
arm group type: Experimental
description: Patient is stimulated with the same polarity and pulse width as the currently chosen stimulation protocol, but with low frequency (80Hz). Voltage/current will be adjusted to maintain TEED similar to that on the regular stimulation protocol.
arm group label: Cycling Low Frequency
arm group type: Experimental
description: Patient is stimulated with the same polarity and pulse width as the currently chosen stimulation protocol, but with low frequency (80Hz) and cycling stimulation: 40sec On - 02 sec OFF. Voltage/current will be adjusted to maintain TEED similar to that on the regular stimulation protocol.
intervention type: Other
intervention name: Cycling deep brain stimulation
description: Deep Brain Stimulation applied in cycling - periods of stimulation ON intercalated with periods of stimulation OFF
arm group label: Continuous Low Frequency
arm group label: Cycling High Frequency
arm group label: Cycling Low Frequency
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rubens G Cury, MD, PhD
role: Principal Investigator
affiliation: University of Sao Paulo General Hospital
last name: Rubens G Cury, MD, PhD
phone: 55 11 26617877
email: rubens_cury@usp.br
last name: Carina C França, MD
phone: 55 11 26617877
email: carina.fr@usp.br
facility: 
status: Recruiting
contact: 
investigator: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo General Hospital
investigator full name: Rubens Gisbert Cury
investigator title: Principal Investigator
mesh term: Parkinson Disease
sharing ipd: Yes
ipd description: all IPD that underlie results in a publication
ipd time frame: Data will be made available indefinitely upon reasonable request from other authors
ipd access criteria: Investigator Rubens Cury will analyse request and decide upon reasonability