<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/NCT04431401</url>
  </required_header>
  <id_info>
    <org_study_id>PPA-rTMS</org_study_id>
    <nct_id>NCT04431401</nct_id>
  </id_info>
  <brief_title>rTMS Treatment of Primary Progressive Aphasia</brief_title>
  <official_title>Repetitive Transcranial Magnetic Stimulation in the Treatment of Primary Progressive Aphasia: 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>
      Primary Progressive Aphasia (PPA) is a neurodegenerative disease in which language function&#xD;
      is gradually and progressively impaired. Patients will eventually be disabled in&#xD;
      communication and have cognition deficits, which put a heavy burden not only on their&#xD;
      families but also on the whole society. However, no effective treatment for PPA has been&#xD;
      explored so far. The current clinical randomized trial is to study the safety and efficacy of&#xD;
      repetitive Transcranial Magnetic Stimulation (rTMS) for the treatment of PPA. Also,&#xD;
      multi-modality of neuroimaging techniques, such as functional MRI and PET will be used to&#xD;
      investigate brain network changing in this procedure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Anticipated">December 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2023</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, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Boston naming test evaluation</measure>
    <time_frame>1 day before the treatment</time_frame>
    <description>Assessment of the language production. Scores range from 0 to 30. Higher scores means better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Boston naming test evaluation</measure>
    <time_frame>1 month, 3 months and 6 months after the treatment</time_frame>
    <description>Assessment of the language production. Scores range from 0 to 30. Higher scores means better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Western Aphasia Battery (WAB) Speech fluency</measure>
    <time_frame>1 day before the treatment</time_frame>
    <description>Assessment of the language production. Scores range from 0 to 20. Higher scores means better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Western Aphasia Battery (WAB) Speech fluency</measure>
    <time_frame>1 month, 3 months and 6 months after the treatment</time_frame>
    <description>Assessment of the language production. Scores range from 0 to 20. Higher scores means better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Western Aphasia Battery (WAB) Repetition</measure>
    <time_frame>1 day before the treatment</time_frame>
    <description>Assessment of the repetition ability. Scores range from 0 to 100. Higher scores means better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Western Aphasia Battery (WAB) Repetition</measure>
    <time_frame>1 month, 3 months and 6 months after the treatment</time_frame>
    <description>Assessment of the repetition ability. Scores range from 0 to 100. Higher scores means better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Western Aphasia Battery (WAB) Word recognition</measure>
    <time_frame>1 day before the treatment</time_frame>
    <description>Assessment of the reading. Scores range from 0 to 60. Higher scores means better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Western Aphasia Battery (WAB) Word recognition</measure>
    <time_frame>1 month, 3 months and 6 months after the treatment</time_frame>
    <description>Assessment of the reading. Scores range from 0 to 60. Higher scores means better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Syntax comprehension part of Bilingual aphasia test (Standard Modern Chinese Version)</measure>
    <time_frame>1 day before the treatment</time_frame>
    <description>Assessment of the grammar ability. Scores range from 0 to 50. Higher scores means better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Syntax comprehension part of Bilingual aphasia test (Standard Modern Chinese Version)</measure>
    <time_frame>1 month, 3 months and 6 months after the treatment</time_frame>
    <description>Assessment of the grammar ability. Scores range from 0 to 50. Higher scores means better outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>functional connectivity map (FC map)</measure>
    <time_frame>1 day before the treatment</time_frame>
    <description>Functional Connectivity was examined using a seed-based voxel-wise correlation approach. The language related brain areas, such as Broca Area and Wernicke Area, were defined as the regions of interest (ROI). Pearson's correlation analysis between the time course of the ROI and that of every voxel in the whole brain was computed for a map of correlation coefficients, which were Fisher's z-transformed and called as z-FC maps. This outcome measurement, the z-FC map, is not numeric data. Z-FC map is a radiographic imaging measurement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>functional connectivity map (FC map)</measure>
    <time_frame>1 month, 3 months and 6 months after the treatment</time_frame>
    <description>Functional Connectivity was examined using a seed-based voxel-wise correlation approach. The language related brain areas, such as Broca Area and Wernicke Area, were defined as the regions of interest (ROI). Pearson's correlation analysis between the time course of the ROI and that of every voxel in the whole brain was computed for a map of correlation coefficients, which were Fisher's z-transformed and called as z-FC maps. This outcome measurement, the z-FC map, is not numeric data. Z-FC map is a radiographic imaging measurement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Standardized Uptake Value (SUV)</measure>
    <time_frame>1 day before the treatment</time_frame>
    <description>PET parameter to evaluate brain metabolism</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Standardized Uptake Value (SUV)</measure>
    <time_frame>1 month, 3 months and 6 months after the treatment</time_frame>
    <description>PET parameter to evaluate brain metabolism</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Primary Progressive Aphasia</condition>
  <condition>Repetitive Transcranical Magnetic Stimulation</condition>
  <arm_group>
    <arm_group_label>rTMS treatment group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participants will be divided into the rTMS treatment group and the sham treatment group by means of randomized methods.The protocol of the treatment is to use rTMS with high frequency 10/20Hz 120%RMT 20 times for one month. The device is Magtism rTMS made in London, UK</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sham treatment group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>The control group is to receive sham treatment. The device is the same as the one used in the real treatment group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Magstim rTMS</intervention_name>
    <description>The device is made in London,UK</description>
    <arm_group_label>rTMS treatment group</arm_group_label>
    <arm_group_label>sham treatment group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of PPA&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Scored below 15 on the mini-mental state exam (MMSE)&#xD;
&#xD;
          -  history of seizures or unexplained loss of consciousness&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  surgical breach of the skull&#xD;
&#xD;
          -  MRI contraindication&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Yuzhou Guan</last_name>
    <phone>8613910081750</phone>
    <email>guanyz001@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Caiyan Liu</last_name>
    <phone>8618601017840</phone>
    <email>liucy-pumch@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yuzhou Guan</last_name>
      <phone>8613910081750</phone>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>June 3, 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>July 31, 2022</last_update_submitted>
  <last_update_submitted_qc>July 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aphasia</mesh_term>
    <mesh_term>Aphasia, Primary Progressive</mesh_term>
    <mesh_term>Pick Disease of the Brain</mesh_term>
    <mesh_term>Frontotemporal Dementia</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/NCT04431401
org study id: PPA-rTMS
nct id: NCT04431401
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Primary Progressive Aphasia (PPA) is a neurodegenerative disease in which language function
      is gradually and progressively impaired. Patients will eventually be disabled in
      communication and have cognition deficits, which put a heavy burden not only on their
      families but also on the whole society. However, no effective treatment for PPA has been
      explored so far. The current clinical randomized trial is to study the safety and efficacy of
      repetitive Transcranial Magnetic Stimulation (rTMS) for the treatment of PPA. Also,
      multi-modality of neuroimaging techniques, such as functional MRI and PET will be used to
      investigate brain network changing in this procedure.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Boston naming test evaluation
time frame: 1 day before the treatment
description: Assessment of the language production. Scores range from 0 to 30. Higher scores means better outcome.
measure: Boston naming test evaluation
time frame: 1 month, 3 months and 6 months after the treatment
description: Assessment of the language production. Scores range from 0 to 30. Higher scores means better outcome.
measure: Western Aphasia Battery (WAB) Speech fluency
time frame: 1 day before the treatment
description: Assessment of the language production. Scores range from 0 to 20. Higher scores means better outcome.
measure: Western Aphasia Battery (WAB) Speech fluency
time frame: 1 month, 3 months and 6 months after the treatment
description: Assessment of the language production. Scores range from 0 to 20. Higher scores means better outcome.
measure: Western Aphasia Battery (WAB) Repetition
time frame: 1 day before the treatment
description: Assessment of the repetition ability. Scores range from 0 to 100. Higher scores means better outcome.
measure: Western Aphasia Battery (WAB) Repetition
time frame: 1 month, 3 months and 6 months after the treatment
description: Assessment of the repetition ability. Scores range from 0 to 100. Higher scores means better outcome.
measure: Western Aphasia Battery (WAB) Word recognition
time frame: 1 day before the treatment
description: Assessment of the reading. Scores range from 0 to 60. Higher scores means better outcome.
measure: Western Aphasia Battery (WAB) Word recognition
time frame: 1 month, 3 months and 6 months after the treatment
description: Assessment of the reading. Scores range from 0 to 60. Higher scores means better outcome.
measure: Syntax comprehension part of Bilingual aphasia test (Standard Modern Chinese Version)
time frame: 1 day before the treatment
description: Assessment of the grammar ability. Scores range from 0 to 50. Higher scores means better outcome.
measure: Syntax comprehension part of Bilingual aphasia test (Standard Modern Chinese Version)
time frame: 1 month, 3 months and 6 months after the treatment
description: Assessment of the grammar ability. Scores range from 0 to 50. Higher scores means better outcome.
measure: functional connectivity map (FC map)
time frame: 1 day before the treatment
description: Functional Connectivity was examined using a seed-based voxel-wise correlation approach. The language related brain areas, such as Broca Area and Wernicke Area, were defined as the regions of interest (ROI). Pearson's correlation analysis between the time course of the ROI and that of every voxel in the whole brain was computed for a map of correlation coefficients, which were Fisher's z-transformed and called as z-FC maps. This outcome measurement, the z-FC map, is not numeric data. Z-FC map is a radiographic imaging measurement.
measure: functional connectivity map (FC map)
time frame: 1 month, 3 months and 6 months after the treatment
description: Functional Connectivity was examined using a seed-based voxel-wise correlation approach. The language related brain areas, such as Broca Area and Wernicke Area, were defined as the regions of interest (ROI). Pearson's correlation analysis between the time course of the ROI and that of every voxel in the whole brain was computed for a map of correlation coefficients, which were Fisher's z-transformed and called as z-FC maps. This outcome measurement, the z-FC map, is not numeric data. Z-FC map is a radiographic imaging measurement.
measure: Standardized Uptake Value (SUV)
time frame: 1 day before the treatment
description: PET parameter to evaluate brain metabolism
measure: Standardized Uptake Value (SUV)
time frame: 1 month, 3 months and 6 months after the treatment
description: PET parameter to evaluate brain metabolism
arm group label: rTMS treatment group
arm group type: Experimental
description: The participants will be divided into the rTMS treatment group and the sham treatment group by means of randomized methods.The protocol of the treatment is to use rTMS with high frequency 10/20Hz 120%RMT 20 times for one month. The device is Magtism rTMS made in London, UK
arm group label: sham treatment group
arm group type: Sham Comparator
description: The control group is to receive sham treatment. The device is the same as the one used in the real treatment group.
intervention type: Device
intervention name: Magstim rTMS
description: The device is made in London,UK
arm group label: rTMS treatment group
arm group label: sham treatment group
criteria: 
gender: All
minimum age: 35 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yuzhou Guan
phone: 8613910081750
email: guanyz001@163.com
last name: Caiyan Liu
phone: 8618601017840
email: liucy-pumch@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Aphasia
mesh term: Aphasia, Primary Progressive
mesh term: Pick Disease of the Brain
mesh term: Frontotemporal Dementia