<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/NCT02969941</url>
  </required_header>
  <id_info>
    <org_study_id>NSFC-81171273-02</org_study_id>
    <nct_id>NCT02969941</nct_id>
  </id_info>
  <brief_title>Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment for Parkinson Disease</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Anhui Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Anhui Medical University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate the treatment effect of continuous transcranial magnetic stimulation on&#xD;
      patients with Parkinson disease, and the underlying neural mechanism by functional MRI&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All patients underwent a medical evaluation that included physical examination and routine&#xD;
      laboratory studies before and after repetitive transcranial magnetic stimulation (rTMS)&#xD;
      treatment. Patients were randomly allocated to rTMS group and the sham group by coin toss.&#xD;
      There are at least 20 patients in each group. The decision to enroll a patient was always&#xD;
      made prior to randomization. Patients were studied using a double-blind design. Study&#xD;
      participants, clinical raters, and all personnel responsible for the clinical care of the&#xD;
      patient remained masked to allocated condition and allocation parameters. Only rTMS&#xD;
      administrators had access to the randomization list; they had minimal contact with the&#xD;
      patients, and no role in assessing clinical symptoms. Each patient would be treated for&#xD;
      continuous 14 days by rTMS.&#xD;
&#xD;
      Before the rTMS treatment, the Unified Parkinson's Disease Rating Scale, and the Non-motor&#xD;
      Symptom Scale were obtained by a trained investigator to assess baseline severity. The&#xD;
      patients had receiving a battery measure of neuropsychological tests(mini-mental state&#xD;
      examination, Montreal cognitive assessment, digital span test, verbal fluency test, Hamilton&#xD;
      depression/anxiety scale, Stroop test, Iowa gambling test, game of dice test, stop signal&#xD;
      test, and delay discount), magnetic resonance imaging scan in multimodalities, and&#xD;
      electroencephalography (EEG) record.&#xD;
&#xD;
      In the second day after the last treatment, all the tests were reassessed. Patients were&#xD;
      instructed to focus their answers on the past 14 days. The patients had also receiving a&#xD;
      battery measure of neuropsychological tests, magnetic resonance imaging scan in&#xD;
      multimodalities, and EEG record.&#xD;
&#xD;
      The clinical symptom and cognition of participants were followed in two month after the last&#xD;
      treatment. They were instructed to focus their answers on the past week. Additionally, they&#xD;
      were also asked to assess the battery of neuropsychological tests, and have magnetic&#xD;
      resonance imaging scan in multimodalities, and EEG record. Afterwards, they were unblinded by&#xD;
      the study coordinator.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 1, 2016</start_date>
  <completion_date type="Actual">January 1, 2019</completion_date>
  <primary_completion_date type="Actual">January 1, 2019</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Symptom improvement assessed by Unified Parkinson's Disease Rating Scale III</measure>
    <time_frame>changes from baseline at 2 weeks post-treatment</time_frame>
    <description>This is an very common clinical motor estimating scale with 14 items and 108' in total. Higher scores indicate worse symptoms.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Timed up and go test</measure>
    <time_frame>changes from baseline at 1, 2, 4, 6 and 10 weeks post-treatment</time_frame>
    <description>Time was taken by an individual to stand up from a standard arm chair, walk a distance of 3 meters, turn, walk back to the chair, and sit down again.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>20m walking test</measure>
    <time_frame>changes from baseline at 1, 2, 4, 6 and 10 weeks post-treatment</time_frame>
    <description>The patients were requested to walk, but not run, for a distance of 20 meters, turn around, walk back again.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non-motor symptoms questionnaire</measure>
    <time_frame>changes from baseline at 1, 2, 4, 6 and 10 weeks post-treatment</time_frame>
    <description>This is a very common clinical scale with nine domains (30 items). Each item was scored on &quot;severity&quot;and &quot;frequency&quot; range from 0 to 3. Higher scores indicate worse symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Unified Parkinson's Disease Rating Scale III</measure>
    <time_frame>changes from baseline at 1, 4, 6, and 10 weeks post-treatment</time_frame>
    <description>This is an very common clinical motor estimating scale, 14 items and 108' in total. Higher scores indicate worse symptoms.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Transcranial Magnetic Stimulation</condition>
  <condition>Functional Magnetic Resonance Imaging</condition>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>Real Stimulation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive active transcranial magnetic stimulation (TMS) daily for two weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Stimulation</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will receive sham transcranial magnetic stimulation (TMS) daily for two weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>transcranial magnetic stimulation</intervention_name>
    <description>The stimulations were performed by MagStim Rapid2.</description>
    <arm_group_label>Placebo Stimulation</arm_group_label>
    <arm_group_label>Real Stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of Parkinson disease (PD) according to the United Kingdom Brain Bank&#xD;
             Criteria, confirmed by a neurologist with expertise in movement disorders.&#xD;
&#xD;
          -  Minimum of 3 years since the formal diagnosis of PD, and requiring dopaminergic&#xD;
             therapy (at a minimum, on levodopa and/or dopamine agonist therapy).&#xD;
&#xD;
          -  On a stable dose of all medications for 2 months; and no anti-PD medication&#xD;
             adjustments in the next 3 months.&#xD;
&#xD;
          -  Age 40 years or older.&#xD;
&#xD;
          -  Mini-mental state examination &gt; 27.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any history or clinical signs of other severe psychiatric illnesses (like major&#xD;
             depression, psychosis or obsessive compulsive disorder).&#xD;
&#xD;
          -  History of head injury, stroke, or other neurologic disease.&#xD;
&#xD;
          -  Organic brain defects on T1 or T2 images.&#xD;
&#xD;
          -  History of seizures or unexplained loss of consciousness.&#xD;
&#xD;
          -  Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator.&#xD;
&#xD;
          -  Family history of medication refractory epilepsy.&#xD;
&#xD;
          -  History of substance abuse within the last 6 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Anhui Medical University</name>
      <address>
        <city>Hefei</city>
        <state>Anhui</state>
        <zip>230032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>March 16, 2019</last_update_submitted>
  <last_update_submitted_qc>March 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Anhui Medical University</investigator_affiliation>
    <investigator_full_name>WANG KAI</investigator_full_name>
    <investigator_title>Director of medical psychological department</investigator_title>
  </responsible_party>
  <keyword>Parkinson Disease</keyword>
  <keyword>Functional Magnetic Resonance Imaging</keyword>
  <keyword>Transcranial Magnetic Stimulation</keyword>
  <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/NCT02969941
org study id: NSFC-81171273-02
nct id: NCT02969941
lead sponsor: 
has dmc: No
To investigate the treatment effect of continuous transcranial magnetic stimulation on
      patients with Parkinson disease, and the underlying neural mechanism by functional MRI
All patients underwent a medical evaluation that included physical examination and routine
      laboratory studies before and after repetitive transcranial magnetic stimulation (rTMS)
      treatment. Patients were randomly allocated to rTMS group and the sham group by coin toss.
      There are at least 20 patients in each group. The decision to enroll a patient was always
      made prior to randomization. Patients were studied using a double-blind design. Study
      participants, clinical raters, and all personnel responsible for the clinical care of the
      patient remained masked to allocated condition and allocation parameters. Only rTMS
      administrators had access to the randomization list; they had minimal contact with the
      patients, and no role in assessing clinical symptoms. Each patient would be treated for
      continuous 14 days by rTMS.

      Before the rTMS treatment, the Unified Parkinson's Disease Rating Scale, and the Non-motor
      Symptom Scale were obtained by a trained investigator to assess baseline severity. The
      patients had receiving a battery measure of neuropsychological tests(mini-mental state
      examination, Montreal cognitive assessment, digital span test, verbal fluency test, Hamilton
      depression/anxiety scale, Stroop test, Iowa gambling test, game of dice test, stop signal
      test, and delay discount), magnetic resonance imaging scan in multimodalities, and
      electroencephalography (EEG) record.

      In the second day after the last treatment, all the tests were reassessed. Patients were
      instructed to focus their answers on the past 14 days. The patients had also receiving a
      battery measure of neuropsychological tests, magnetic resonance imaging scan in
      multimodalities, and EEG record.

      The clinical symptom and cognition of participants were followed in two month after the last
      treatment. They were instructed to focus their answers on the past week. Additionally, they
      were also asked to assess the battery of neuropsychological tests, and have magnetic
      resonance imaging scan in multimodalities, and EEG record. Afterwards, they were unblinded by
      the study coordinator.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Symptom improvement assessed by Unified Parkinson's Disease Rating Scale III
time frame: changes from baseline at 2 weeks post-treatment
description: This is an very common clinical motor estimating scale with 14 items and 108' in total. Higher scores indicate worse symptoms.
measure: Timed up and go test
time frame: changes from baseline at 1, 2, 4, 6 and 10 weeks post-treatment
description: Time was taken by an individual to stand up from a standard arm chair, walk a distance of 3 meters, turn, walk back to the chair, and sit down again.
measure: 20m walking test
time frame: changes from baseline at 1, 2, 4, 6 and 10 weeks post-treatment
description: The patients were requested to walk, but not run, for a distance of 20 meters, turn around, walk back again.
measure: Non-motor symptoms questionnaire
time frame: changes from baseline at 1, 2, 4, 6 and 10 weeks post-treatment
description: This is a very common clinical scale with nine domains (30 items). Each item was scored on "severity"and "frequency" range from 0 to 3. Higher scores indicate worse symptoms.
measure: Unified Parkinson's Disease Rating Scale III
time frame: changes from baseline at 1, 4, 6, and 10 weeks post-treatment
description: This is an very common clinical motor estimating scale, 14 items and 108' in total. Higher scores indicate worse symptoms.
arm group label: Real Stimulation
arm group type: Active Comparator
description: Participants will receive active transcranial magnetic stimulation (TMS) daily for two weeks
arm group label: Placebo Stimulation
arm group type: Placebo Comparator
description: Participants will receive sham transcranial magnetic stimulation (TMS) daily for two weeks
intervention type: Other
intervention name: transcranial magnetic stimulation
description: The stimulations were performed by MagStim Rapid2.
arm group label: Placebo Stimulation
arm group label: Real Stimulation
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Anhui Medical University
investigator full name: WANG KAI
investigator title: Director of medical psychological department
mesh term: Parkinson Disease
sharing ipd: No