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/NCT06009471</url>
    </required_header>
    <id_info>
      <org_study_id>LCYJ-B06</org_study_id>
      <nct_id>NCT06009471</nct_id>
    </id_info>
    <brief_title>A Multicenter Clinical Study of rTMS for Parkinson's Disease</brief_title>
    <official_title>A Multicenter Clinical Study of rTMS for Parkinson's Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Affiliated Hospital of Nantong University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Affiliated Hospital of Nantong University</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>
        Through rTMS, motor dysfunction and non-motor dysfunction of PD patients can be improved,&#xD;
        working and living ability and quality of life of patients can be improved, and social burden&#xD;
        and family burden can be reduced.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        According to the inclusion criteria, a total of 200 patients with Parkinson's disease were&#xD;
        planned to be enrolled in each center, and randomly divided into control group (conventional&#xD;
        treatment) and observation group (conventional treatment +rTMS) for a treatment cycle of 4&#xD;
        weeks. They were followed up for 3 months before treatment, 2 weeks and 4 weeks,&#xD;
        respectively, after treatment, to evaluate the efficacy and function. The unified Parkinson's&#xD;
        Disease Rating Scale (UPDRS) was used. Cognitive function assessment Monteller Cognitive&#xD;
        Assessment Scale (MoCA); Barthel Index for daily living activities; Depression assessment&#xD;
        Hamilton Depression Scale (HAMD); Hamilton Anxiety Scale (HAMA); Sleep assessment PD Sleep&#xD;
        Scale (PDSS); Pain assessment King Parkinson's Pain Assessment (KPPS) and adverse events were&#xD;
        recorded.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 1, 2023</start_date>
    <completion_date type="Anticipated">August 2025</completion_date>
    <primary_completion_date type="Anticipated">August 2025</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>
      <intervention_model_description>A total of 200 patients with Parkinson's disease were enrolled in each center and randomly divided into control group (routine treatment) and observation group (routine treatment +rTMS).</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Unified Parkinson's disease rating Scale （UPDRS）</measure>
      <time_frame>The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.</time_frame>
      <description>16 items, each with a score of 0-4, and the score is directly proportional to the severity of PD motor symptoms.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Montreal Cognitive Assessment Scale (MoCA)</measure>
      <time_frame>The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.</time_frame>
      <description>Full score of 30 points,&gt;=26 points normal,. Mild cognitive impairment (MCI) on a scale of 18-26, moderate on a scale of 10-17, and severe on a scale of&lt;10.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>King's Parkinson's Pain Assessment (KPPS)</measure>
      <time_frame>The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.</time_frame>
      <description>Evaluate the pain degree and quality of life of patients with Parkinson's disease, including 14 items in 7 aspects, including skeletal muscle pain, Chronic pain, symptom fluctuation related pain, nocturnal pain, orofacial pain, distention pain, and nerve root pain. Each score is expressed as pain severity (0-3 levels) multiplied by frequency (0-4 levels), that is, 0-12 points. The total score is 168 points. The higher the score, the more severe the pain.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>PD Sleep Scale (PDSS)</measure>
      <time_frame>The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.</time_frame>
      <description>Evaluate the patient's sleep status, with a total of 15 items on the scale. Each item is scored on a scale of 0-10 points, with a lower score indicating poorer sleep status.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Activities of daily living Assessment - Barthel</measure>
      <time_frame>The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.</time_frame>
      <description>The total score of the index is 100 points, and the higher the score, the better the self-care ability and the less dependence. Those scoring above 60 can basically complete basic Activities of daily living, 59-41 need some help to complete, 40-21 need a lot of help. Those who score below 20 are in complete need of help and cannot take care of themselves.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Hamilton Depression Scale (HAMD)</measure>
      <time_frame>The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.</time_frame>
      <description>Evaluate depressive status, including 14 5-level scoring items (0-4 points) and 10 3-level scoring items (0-2 points). Score&lt;8, no depression; 8 to 35 points, may be mild or moderate depression 35 points, may be severe depression.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hamilton Anxiety Scale (HAMA)</measure>
      <time_frame>The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.</time_frame>
      <description>Include 14 projects. All items of HAMA adopt a 5-level scoring method of 0~4 points, and the criteria of each level are: (0) is Asymptomatic; (1) Light; (2) Moderate; (3) Heavy; (4) Extremely heavy. The total score of HAMA can better reflect the severity of anxiety symptoms. The total score can be used to evaluate the severity of anxiety symptoms and evaluate the effectiveness of various drugs and psychological interventions in patients with anxiety and depression disorders. According to the data provided by the collaborative group of the Chinese scale, if the total score exceeds 29 points, it may be severe anxiety; Above 21 points, there must be obvious anxiety; If the score exceeds 14, there must be anxiety; If the score exceeds 7, there may be anxiety; If the score is less than 7, there are no symptoms of anxiety. Generally speaking, the total score of HAMA is higher than 14 points, indicating clinically significant anxiety symptoms for the evaluated subject.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Parkinson's Disease</condition>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>All participants were treated with routine treatment in Neurology.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Experimental group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>All participants were treated with routine treatment in Neurology and rTMS treatment.&#xD;
  rTMS parameters were set to stimulate the site: bilateral primary motor cortex; Stimulus frequency :5Hz; Pulse number: 1000 pulses per day, 500 on the left and 500 on the right; Stimulus intensity :90% resting threshold; Coil: 70mm round coil; Once a day, 30 minutes each time, 5 days a week for 4 weeks</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Routine treatment in Neurology</intervention_name>
      <description>Routine treatment in Neurology department, including drug treatment,etc.</description>
      <arm_group_label>Control group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Routine treatment in Neurology and rTMS</intervention_name>
      <description>Add rTMS to routine treatment. Low frequency rTMS is often used to treat cortical hyperexcitability and high frequency rTMS to treat hypoexcitability</description>
      <arm_group_label>Experimental group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Hoehn-YAHR classification is between 1 and 2；&#xD;
  &#xD;
            -  Have a primary school education or above and can read the scale used in this study;&#xD;
  &#xD;
            -  MoCA score between 20 and 24, mild cognitive impairment ;&#xD;
  &#xD;
            -  Aged between 30 and 80, regardless of gender；&#xD;
  &#xD;
            -  Voluntarily participate and sign informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  patients with cerebrovascular accident, craniocerebral injury and other diseases&#xD;
               affecting muscle tension;&#xD;
  &#xD;
            -  patients with serious mental disorders and cognitive disorders who cannot cooperate&#xD;
               with assessment;&#xD;
  &#xD;
            -  patients with severe liver, kidney, heart dysfunction and severe physical disorders;&#xD;
  &#xD;
            -  Implanted devices such as pacemakers are installed inside the body;&#xD;
  &#xD;
            -  drug-induced Parkinson's syndrome or Parkinson's superposition syndrome;&#xD;
  &#xD;
            -  Have a history of epilepsy;&#xD;
  &#xD;
            -  Women during pregnancy and breastfeeding.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <gender_based>Yes</gender_based>
      <gender_description>self-representation of gender identity</gender_description>
      <minimum_age>30 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Aisong Guo</last_name>
      <phone>15851300188</phone>
      <email>guoasg@ntu.edu.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>rTMS</name>
        <address>
          <city>Nantong</city>
          <state>Jiangsu</state>
          <zip>226001</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Aisong Guo</last_name>
        <phone>15851300188</phone>
        <email>guoasg@ntu.edu.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>June 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 20, 2023</last_update_submitted>
    <last_update_submitted_qc>August 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Parkinson's disease</keyword>
    <keyword>repetitive transcranial magnetic stimulation(rTMS)</keyword>
    <keyword>Unified Parkinson's Disease Rating Scale (UPDRS)</keyword>
    <keyword>Montreal Cognitive Assessment Scale (MoCA)</keyword>
    <keyword>activity of daily living(ADL)</keyword>
    <keyword>PD Sleep Scale (PDSS)</keyword>
    <keyword>King's Parkinson's Pain Assessment (KPPS)</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>
  
  
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/NCT06009471
  org study id: LCYJ-B06
  nct id: NCT06009471
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Through rTMS, motor dysfunction and non-motor dysfunction of PD patients can be improved,
        working and living ability and quality of life of patients can be improved, and social burden
        and family burden can be reduced.
  According to the inclusion criteria, a total of 200 patients with Parkinson's disease were
        planned to be enrolled in each center, and randomly divided into control group (conventional
        treatment) and observation group (conventional treatment +rTMS) for a treatment cycle of 4
        weeks. They were followed up for 3 months before treatment, 2 weeks and 4 weeks,
        respectively, after treatment, to evaluate the efficacy and function. The unified Parkinson's
        Disease Rating Scale (UPDRS) was used. Cognitive function assessment Monteller Cognitive
        Assessment Scale (MoCA); Barthel Index for daily living activities; Depression assessment
        Hamilton Depression Scale (HAMD); Hamilton Anxiety Scale (HAMA); Sleep assessment PD Sleep
        Scale (PDSS); Pain assessment King Parkinson's Pain Assessment (KPPS) and adverse events were
        recorded.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: A total of 200 patients with Parkinson's disease were enrolled in each center and randomly divided into control group (routine treatment) and observation group (routine treatment +rTMS).
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Unified Parkinson's disease rating Scale （UPDRS）
  time frame: The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.
  description: 16 items, each with a score of 0-4, and the score is directly proportional to the severity of PD motor symptoms.
  measure: Montreal Cognitive Assessment Scale (MoCA)
  time frame: The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.
  description: Full score of 30 points,>=26 points normal,. Mild cognitive impairment (MCI) on a scale of 18-26, moderate on a scale of 10-17, and severe on a scale of<10.
  measure: King's Parkinson's Pain Assessment (KPPS)
  time frame: The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.
  description: Evaluate the pain degree and quality of life of patients with Parkinson's disease, including 14 items in 7 aspects, including skeletal muscle pain, Chronic pain, symptom fluctuation related pain, nocturnal pain, orofacial pain, distention pain, and nerve root pain. Each score is expressed as pain severity (0-3 levels) multiplied by frequency (0-4 levels), that is, 0-12 points. The total score is 168 points. The higher the score, the more severe the pain.
  measure: PD Sleep Scale (PDSS)
  time frame: The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.
  description: Evaluate the patient's sleep status, with a total of 15 items on the scale. Each item is scored on a scale of 0-10 points, with a lower score indicating poorer sleep status.
  measure: Activities of daily living Assessment - Barthel
  time frame: The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.
  description: The total score of the index is 100 points, and the higher the score, the better the self-care ability and the less dependence. Those scoring above 60 can basically complete basic Activities of daily living, 59-41 need some help to complete, 40-21 need a lot of help. Those who score below 20 are in complete need of help and cannot take care of themselves.
  measure: Hamilton Depression Scale (HAMD)
  time frame: The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.
  description: Evaluate depressive status, including 14 5-level scoring items (0-4 points) and 10 3-level scoring items (0-2 points). Score<8, no depression; 8 to 35 points, may be mild or moderate depression 35 points, may be severe depression.
  measure: Hamilton Anxiety Scale (HAMA)
  time frame: The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.
  description: Include 14 projects. All items of HAMA adopt a 5-level scoring method of 0~4 points, and the criteria of each level are: (0) is Asymptomatic; (1) Light; (2) Moderate; (3) Heavy; (4) Extremely heavy. The total score of HAMA can better reflect the severity of anxiety symptoms. The total score can be used to evaluate the severity of anxiety symptoms and evaluate the effectiveness of various drugs and psychological interventions in patients with anxiety and depression disorders. According to the data provided by the collaborative group of the Chinese scale, if the total score exceeds 29 points, it may be severe anxiety; Above 21 points, there must be obvious anxiety; If the score exceeds 14, there must be anxiety; If the score exceeds 7, there may be anxiety; If the score is less than 7, there are no symptoms of anxiety. Generally speaking, the total score of HAMA is higher than 14 points, indicating clinically significant anxiety symptoms for the evaluated subject.
  arm group label: Control group
  arm group type: Active Comparator
  description: All participants were treated with routine treatment in Neurology.
  arm group label: Experimental group
  arm group type: Experimental
  description: All participants were treated with routine treatment in Neurology and rTMS treatment.
  rTMS parameters were set to stimulate the site: bilateral primary motor cortex; Stimulus frequency :5Hz; Pulse number: 1000 pulses per day, 500 on the left and 500 on the right; Stimulus intensity :90% resting threshold; Coil: 70mm round coil; Once a day, 30 minutes each time, 5 days a week for 4 weeks
  intervention type: Other
  intervention name: Routine treatment in Neurology
  description: Routine treatment in Neurology department, including drug treatment,etc.
  arm group label: Control group
  intervention type: Device
  intervention name: Routine treatment in Neurology and rTMS
  description: Add rTMS to routine treatment. Low frequency rTMS is often used to treat cortical hyperexcitability and high frequency rTMS to treat hypoexcitability
  arm group label: Experimental group
  criteria: 
  gender: All
  gender based: Yes
  gender description: self-representation of gender identity
  minimum age: 30 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Aisong Guo
  phone: 15851300188
  email: guoasg@ntu.edu.cn
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Parkinson Disease
  sharing ipd: No