<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/NCT04431570</url>
  </required_header>
  <id_info>
    <org_study_id>rTMSPDFOG-PUMCH</org_study_id>
    <nct_id>NCT04431570</nct_id>
  </id_info>
  <brief_title>Repetitive Transcranial Magnetic Stimulation for the Treatment of Freezing of Gait in Parkinson's Disease</brief_title>
  <official_title>Repetitive Transcranial Magnetic Stimulation for the Treatment of Freezing of Gait in Parkinson's Disease: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking Union Medical College Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Freezing of gait (FOG) is a common and devastating symptom in advanced stage Parkinson's&#xD;
      disease (PD), which contributes to falls and disability. Unfortunately, there is no effective&#xD;
      pharmacological treatment for FOG. It is suggested that the cortex-basal ganglia circuit,&#xD;
      especially the frontal lobe, plays an important role in the pathogenesis of FOG. Repetitive&#xD;
      transcranial magnetic stimulation (rTMS) effects over the cortex and affects the subcortical&#xD;
      neural circuits. Previous studies have demonstrated that rTMS can improve FOG for PD&#xD;
      patients. In the present randomized controlled trial (RCT) study, the invastigators aim to&#xD;
      investigate the efficiency of rTMS over different motor regions of frontal lobe. The efficacy&#xD;
      of treatment is evaluated by the score of FOG questionnaire and FOG provoking test, and the&#xD;
      changing of neural network shown by functional magnetic resonance imaging (FMRI). Then the&#xD;
      effects of rTMS over different brain regions will be compared for choosing a better target.&#xD;
      The study will provide the evidence for non-invasive neuro-modulation of Parkinson's disease&#xD;
      with freezing of gait (PD-FOG).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 15, 2020</start_date>
  <completion_date type="Anticipated">June 14, 2022</completion_date>
  <primary_completion_date type="Anticipated">April 14, 2022</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the change of freezing of gait questionnaire (FOGQ)</measure>
    <time_frame>through study completion, an average of 2 weeks</time_frame>
    <description>a self-assessment scale for evaluating FOG severity，the minimum value is 0, the maximum value is 24, and higher scores mean a worse outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the change of freezing of gait score (FOG score)</measure>
    <time_frame>through study completion, an average of 2 weeks</time_frame>
    <description>assess the severity of FOG, the minimum value is 0, the maximum value is 36, and higher scores mean a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the change of score of Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III</measure>
    <time_frame>through study completion, an average of 2 weeks</time_frame>
    <description>assess the motor ability, the minimum value is 0, the maximum value is 132, and higher scores mean a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the change of Hamilton Depression (HAMD) Scale</measure>
    <time_frame>through study completion, an average of 2 weeks</time_frame>
    <description>assess the severity of depression, the minimum value is 0, the maximum value is 76, and higher scores mean a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the change of Mini-mental State Examination (MMSE) scale</measure>
    <time_frame>through study completion, an average of 2 weeks</time_frame>
    <description>assess the severity of mental state, the minimum value is 0, the maximum value is 30, and higher scores mean a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the change of Parkinson's Disease Questionnaire (PDQ-39)</measure>
    <time_frame>through study completion, an average of 2 weeks</time_frame>
    <description>assess the quality of life, the minimum value is 0, the maximum value is 156, and higher scores mean a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>functional image of the brain (FMRI)</measure>
    <time_frame>through study completion, an average of 10 days</time_frame>
    <description>graph theoretical analysis of the brain network</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">66</enrollment>
  <condition>Parkinson Disease</condition>
  <condition>Gait Disorders, Neurologic</condition>
  <arm_group>
    <arm_group_label>rTMS over M1 region</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The stimulus intensity was set to 100% of the resting motor threshold. Ten sessions of rTMS were delivered over 2 weeks, one session per day for 5 consecutive days per week. Each session consisted of 10 trains of 100 pulses at 10Hz with an inter-train interval of 40 seconds. In this group, the target of rTMS is M1 region.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>rTMS over supplementary motor area (SMA)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The stimulus intensity was set to 100% of the resting motor threshold. Ten sessions of rTMS were delivered over 2 weeks, one session per day for 5 consecutive days per week. Each session consisted of 10 trains of 100 pulses at 10Hz with an inter-train interval of 40 seconds. In this group, the target of rTMS is SMA region.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sham stimulation</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>rTMS</intervention_name>
    <description>The device is made in London, United Kingdom</description>
    <arm_group_label>rTMS over M1 region</arm_group_label>
    <arm_group_label>rTMS over supplementary motor area (SMA)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>sham stimulation</intervention_name>
    <description>the device of sham stimulation was MagStim MC-P-B70 placebo butterfly coil</description>
    <arm_group_label>sham stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects fulfilled the diagnosis of idiopathic Parkinson's disease according to MDS-PD&#xD;
             criteria&#xD;
&#xD;
          -  Hoehn &amp; Yahr (H-Y) stage was 2 or 3&#xD;
&#xD;
          -  All subjects had freezing of gait which was identified by FOGQ&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cognitive impairment (MMSE score&lt;22) or major depression (HAMD-24 score&gt;25)&#xD;
&#xD;
          -  severe visual and/or haring impairment&#xD;
&#xD;
          -  significant medical or psychiatric illnesses&#xD;
&#xD;
          -  history of deep brain stimulation (DBS) surgery or pacemaker implantation. MRI cannot&#xD;
             be performed in those patients&#xD;
&#xD;
          -  current treatment with medication cannot be maintained during the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Han Wang, doctor</last_name>
    <phone>+8618600044179</phone>
    <email>18600044179@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Dan Xu, doctor</last_name>
    <phone>+8618614069673</phone>
    <email>pumc04xd@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Taisheng Li, MD. PhD.</last_name>
      <phone>86 10 65295086</phone>
      <email>Litsh@263.net</email>
    </contact>
    <investigator>
      <last_name>Taisheng Li, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ling Luo, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>April 27, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>June 11, 2020</last_update_submitted>
  <last_update_submitted_qc>June 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>freezing of gait</keyword>
  <keyword>FMRI</keyword>
  <keyword>rTMS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
    <mesh_term>Nervous System Diseases</mesh_term>
    <mesh_term>Gait Disorders, Neurologic</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/NCT04431570
org study id: rTMSPDFOG-PUMCH
nct id: NCT04431570
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Freezing of gait (FOG) is a common and devastating symptom in advanced stage Parkinson's
      disease (PD), which contributes to falls and disability. Unfortunately, there is no effective
      pharmacological treatment for FOG. It is suggested that the cortex-basal ganglia circuit,
      especially the frontal lobe, plays an important role in the pathogenesis of FOG. Repetitive
      transcranial magnetic stimulation (rTMS) effects over the cortex and affects the subcortical
      neural circuits. Previous studies have demonstrated that rTMS can improve FOG for PD
      patients. In the present randomized controlled trial (RCT) study, the invastigators aim to
      investigate the efficiency of rTMS over different motor regions of frontal lobe. The efficacy
      of treatment is evaluated by the score of FOG questionnaire and FOG provoking test, and the
      changing of neural network shown by functional magnetic resonance imaging (FMRI). Then the
      effects of rTMS over different brain regions will be compared for choosing a better target.
      The study will provide the evidence for non-invasive neuro-modulation of Parkinson's disease
      with freezing of gait (PD-FOG).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: the change of freezing of gait questionnaire (FOGQ)
time frame: through study completion, an average of 2 weeks
description: a self-assessment scale for evaluating FOG severity，the minimum value is 0, the maximum value is 24, and higher scores mean a worse outcome.
measure: the change of freezing of gait score (FOG score)
time frame: through study completion, an average of 2 weeks
description: assess the severity of FOG, the minimum value is 0, the maximum value is 36, and higher scores mean a worse outcome.
measure: the change of score of Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III
time frame: through study completion, an average of 2 weeks
description: assess the motor ability, the minimum value is 0, the maximum value is 132, and higher scores mean a worse outcome.
measure: the change of Hamilton Depression (HAMD) Scale
time frame: through study completion, an average of 2 weeks
description: assess the severity of depression, the minimum value is 0, the maximum value is 76, and higher scores mean a worse outcome.
measure: the change of Mini-mental State Examination (MMSE) scale
time frame: through study completion, an average of 2 weeks
description: assess the severity of mental state, the minimum value is 0, the maximum value is 30, and higher scores mean a worse outcome.
measure: the change of Parkinson's Disease Questionnaire (PDQ-39)
time frame: through study completion, an average of 2 weeks
description: assess the quality of life, the minimum value is 0, the maximum value is 156, and higher scores mean a worse outcome.
measure: functional image of the brain (FMRI)
time frame: through study completion, an average of 10 days
description: graph theoretical analysis of the brain network
arm group label: rTMS over M1 region
arm group type: Experimental
description: The stimulus intensity was set to 100% of the resting motor threshold. Ten sessions of rTMS were delivered over 2 weeks, one session per day for 5 consecutive days per week. Each session consisted of 10 trains of 100 pulses at 10Hz with an inter-train interval of 40 seconds. In this group, the target of rTMS is M1 region.
arm group label: rTMS over supplementary motor area (SMA)
arm group type: Experimental
description: The stimulus intensity was set to 100% of the resting motor threshold. Ten sessions of rTMS were delivered over 2 weeks, one session per day for 5 consecutive days per week. Each session consisted of 10 trains of 100 pulses at 10Hz with an inter-train interval of 40 seconds. In this group, the target of rTMS is SMA region.
arm group label: sham stimulation
arm group type: Sham Comparator
intervention type: Device
intervention name: rTMS
description: The device is made in London, United Kingdom
arm group label: rTMS over M1 region
arm group label: rTMS over supplementary motor area (SMA)
intervention type: Device
intervention name: sham stimulation
description: the device of sham stimulation was MagStim MC-P-B70 placebo butterfly coil
arm group label: sham stimulation
criteria: 
gender: All
minimum age: 50 Years
maximum age: 70 Years
healthy volunteers: No
last name: Han Wang, doctor
phone: +8618600044179
email: 18600044179@163.com
last name: Dan Xu, doctor
phone: +8618614069673
email: pumc04xd@163.com
facility: 
contact: 
investigator: 
investigator: 
country: China
responsible party type: Sponsor
mesh term: Parkinson Disease
mesh term: Nervous System Diseases
mesh term: Gait Disorders, Neurologic