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/NCT05999318</url>
    </required_header>
    <id_info>
      <org_study_id>CPSA03DB40</org_study_id>
      <nct_id>NCT05999318</nct_id>
    </id_info>
    <brief_title>pBFS-guided cTBS Over the Superior Temporal Gyrus for Aphasia After Ischemic Stroke</brief_title>
    <official_title>Personalized Brain Functional Sector-guided Continuous Theta Burst Stimulation Therapy Targeting at Superior Temporal Gyrus for Aphasia After Ischemic Stroke: a RCT</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Changping Laboratory</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Changping Laboratory</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>
        The objective of this trial is to evaluate the effectiveness and safeness of continuous Theta&#xD;
        Burst Stimulation (cTBS) over the right Superior Temporal Gyrus (STG), guided by personalized&#xD;
        Brain Function Sector (pBFS) technology, on language function recovery in patients with&#xD;
        post-ischemic stroke aphasia.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Increasing evidence suggests that rTMS has been effective in treating various psychological&#xD;
        and neurological diseases, including treating post-stroke symptoms. Using the personalized&#xD;
        brain functional sectors (pBFS) technique, investigators could precisely identify&#xD;
        individualized brain functional networks and the personalized language-related stimulation&#xD;
        site based on the resting-state functional MRI data. The current study proposes to conduct a&#xD;
        double-blinded, randomized and parallel controlled design trial, to investigate the efficacy&#xD;
        and safety of pBFS-guided personalized rTMS intervention in post-stroke aphasic patients.&#xD;
  &#xD;
        Subjects will be randomly assigned to the following two groups: active continuous TBS (cTBS)&#xD;
        group, or a sham control group. The allocation ratio will be 1:1. The stimulation protocol&#xD;
        consisted of a 3-week treatment, with 5 consecutive workdays each week (totally 15&#xD;
        day-treatment) . The stimulation procedure will be assisted with real-time neuronavigation to&#xD;
        ensure its precision.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 20, 2023</start_date>
    <completion_date type="Anticipated">August 20, 2025</completion_date>
    <primary_completion_date type="Anticipated">August 20, 2024</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>Change in the Western Aphasia Battery scores</measure>
      <time_frame>baseline, end of the 3-week therapy</time_frame>
      <description>The first four subsets of the WAB (Spontaneous Speech, Auditory verbal comprehension, Repetition, Naming and word finding) will be used to evaluate the participants' language ability impairments. A Chinese adapted version of WAB will be used. The scores from all four subsets will be calculated as an Aphasia Quotient (ranging from 0 to 100), with lower Aphasia Quotients indicating poorer language abilities.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in the Western Aphasia Battery scores</measure>
      <time_frame>baseline, end of the 5-day therapy, 90 days after treatment initiation</time_frame>
      <description>The first four subsets of the WAB (Spontaneous Speech, Auditory verbal comprehension, Repetition, Naming and word finding) will be used to evaluate the participants' language ability impairments. A Chinese adapted version of WAB will be used. The scores from all four subsets will be calculated as an Aphasia Quotient (ranging from 0 to 100), with lower Aphasia Quotients indicating poorer language abilities.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Boston Diagnostic Aphasia Examination Severity Ratings</measure>
      <time_frame>baseline，end of the 3-week therapy，90 days after treatment initiation</time_frame>
      <description>The Boston Diagnostic Aphasia Examination (BDAE) Severity Ratings is a clinical tool used to evaluate the severity and type of aphasia in individuals. The assessment includes four domains: communication abilities, language content, speech sound production and response abilities.BDAE severity ratings range from level 0 to level 5, with lower scores indicating more severe aphasia.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Token test</measure>
      <time_frame>baseline，end of the 3-week therapy，90 days after treatment initiation</time_frame>
      <description>The Token Test is a language assessment tool used to evaluate a person's ability to understand spoken language and follow instructions. Each correct response in each task is awarded one point, typically. Different point values may be assigned based on the complexity of the task. The total score is calculated by adding up the accumulated scores across all tasks. The total scores range from 0 to 36, with higher scores indicating better language abilities.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Chinese-version Stroke and Aphasia Quality of Life Scale 39-generic version (SAQOL-39g)</measure>
      <time_frame>baseline，end of the 3-week therapy，90 days after treatment initiation</time_frame>
      <description>The SAQOL-39g is a quality of life assessment tool that is used to evaluate the impact of stroke and aphasia on a patient's quality of life. It consists of 39 items that cover a range of domains related to the patient's quality of life, such as communication, physical functioning, mood, and social support. The items are rated on a 5-point Likert scale ranging from &quot;not at all&quot; to &quot;very much&quot;, with higher scores indicating better quality of life.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Stroke, Ischemic</condition>
    <condition>Aphasia</condition>
    <arm_group>
      <arm_group_label>active cTBS group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>active cTBS combined with speech language therapy</description>
    </arm_group>
    <arm_group>
      <arm_group_label>sham cTBS group</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>sham cTBS combined with speech language therapy</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>active continuous Theta Burst Stimulation</intervention_name>
      <description>Each patient will receive two 600-pulse cTBS stimulations per day, parted by a 15-minute rest period (a total of 1200 pulses daily), for 3-week treatment, with 5 consecutive workdays each week.</description>
      <arm_group_label>active cTBS group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>sham continuous Theta Burst Stimulation</intervention_name>
      <description>Each patient will receive two sham 600-pulse cTBS stimulations per day, parted by a 15-minute rest period (a total of 1200 pulses daily), for 3-week treatment, with 5 consecutive workdays each week.</description>
      <arm_group_label>sham cTBS group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  The patient's age ranges from 35 to 75 years old (including 35 and 75 years old);&#xD;
  &#xD;
            -  Meet the diagnostic criteria for acute ischemic stroke (diagnosed according to the&#xD;
               &quot;Guidelines for the Early Management of Patients With Acute Ischemic Stroke: 2019&#xD;
               Update to the 2018 Guidelines for the Early Management of Acute Ischemic Stroke&quot;&#xD;
               written by the American Heart Association/American Stroke Association in 2019 and the&#xD;
               &quot;Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke 2018&quot;&#xD;
               compiled by the Neurology Branch of the Chinese Medical Association in 2018), with&#xD;
               lesions in the left hemisphere, a duration of ≥15 days and ≤3 months;&#xD;
  &#xD;
            -  Diagnosed as aphasia patient according to the Chinese version of Western Aphasia&#xD;
               Battery (WAB), with a WAB-aphasia quotient of less than 93.8 points;&#xD;
  &#xD;
            -  First onset of stroke;&#xD;
  &#xD;
            -  Normal language function before the onset of stroke, and the patient's native language&#xD;
               is Chinese with at least 6 years of education;&#xD;
  &#xD;
            -  Understand the trial and signed the informed consent form.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Combined severe dysarthria (NIHSS item 10 score ≥2 points);&#xD;
  &#xD;
            -  Aphasia caused by bilateral hemisphere stroke, brain tumor, traumatic brain injury,&#xD;
               Parkinson's disease, motor neuron disease, or other diseases；&#xD;
  &#xD;
            -  Patients with implanted electronic devices such as cardiac pacemakers, cochlear&#xD;
               implants, or other metal foreign bodies, or those with MRI contraindications such as&#xD;
               claustrophobia or TMS treatment contraindications;&#xD;
  &#xD;
            -  History of epilepsy;&#xD;
  &#xD;
            -  Patient with concomitant severe systemic diseases affecting the heart, lungs, liver,&#xD;
               kidneys, etc., and uncontrolled by conventional medication, as detected and confirmed&#xD;
               through laboratory testing and examination;&#xD;
  &#xD;
            -  Patients with consciousness disorders (NIHSS 1(a) score ≥1);&#xD;
  &#xD;
            -  Patients with malignant hypertension;&#xD;
  &#xD;
            -  Patients with severe organic diseases, such as malignant tumors, with an expected&#xD;
               survival time of less than 1 year;&#xD;
  &#xD;
            -  Patients with severe hearing, visual, cognitive impairment or inability to cooperate&#xD;
               with the trial;&#xD;
  &#xD;
            -  Patients with severe depression, anxiety, or diagnosed with other mental illnesses&#xD;
               that prevent them from completing the trial;&#xD;
  &#xD;
            -  Patients who have received other neuromodulation treatments such as TMS, transcranial&#xD;
               electric stimulation, etc. in the 3 months prior to enrollment;&#xD;
  &#xD;
            -  Patients with a history of alcoholism, drug abuse, or other substance abuse;&#xD;
  &#xD;
            -  Patients with other abnormal findings that the researchers judge are not suitable for&#xD;
               participation in this trial;&#xD;
  &#xD;
            -  Patients who are unable to complete follow-up due to geographical or other reasons;&#xD;
  &#xD;
            -  Women of childbearing age who are currently pregnant, breastfeeding, or planning or&#xD;
               may become pregnant during the trial;&#xD;
  &#xD;
            -  Patients who are currently participating in other clinical trials.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>35 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Hesheng Liu, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>Changping Laboratory</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Na Xu, PhD</last_name>
      <phone>010-80726688</phone>
      <email>naxu@cpl.ac.cn</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</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>Stroke</mesh_term>
      <mesh_term>Ischemic Stroke</mesh_term>
      <mesh_term>Aphasia</mesh_term>
      <mesh_term>Ischemia</mesh_term>
    </condition_browse>
    <!-- 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/NCT05999318
  org study id: CPSA03DB40
  nct id: NCT05999318
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The objective of this trial is to evaluate the effectiveness and safeness of continuous Theta
        Burst Stimulation (cTBS) over the right Superior Temporal Gyrus (STG), guided by personalized
        Brain Function Sector (pBFS) technology, on language function recovery in patients with
        post-ischemic stroke aphasia.
  Increasing evidence suggests that rTMS has been effective in treating various psychological
        and neurological diseases, including treating post-stroke symptoms. Using the personalized
        brain functional sectors (pBFS) technique, investigators could precisely identify
        individualized brain functional networks and the personalized language-related stimulation
        site based on the resting-state functional MRI data. The current study proposes to conduct a
        double-blinded, randomized and parallel controlled design trial, to investigate the efficacy
        and safety of pBFS-guided personalized rTMS intervention in post-stroke aphasic patients.
  
        Subjects will be randomly assigned to the following two groups: active continuous TBS (cTBS)
        group, or a sham control group. The allocation ratio will be 1:1. The stimulation protocol
        consisted of a 3-week treatment, with 5 consecutive workdays each week (totally 15
        day-treatment) . The stimulation procedure will be assisted with real-time neuronavigation to
        ensure its precision.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Change in the Western Aphasia Battery scores
  time frame: baseline, end of the 3-week therapy
  description: The first four subsets of the WAB (Spontaneous Speech, Auditory verbal comprehension, Repetition, Naming and word finding) will be used to evaluate the participants' language ability impairments. A Chinese adapted version of WAB will be used. The scores from all four subsets will be calculated as an Aphasia Quotient (ranging from 0 to 100), with lower Aphasia Quotients indicating poorer language abilities.
  measure: Change in the Western Aphasia Battery scores
  time frame: baseline, end of the 5-day therapy, 90 days after treatment initiation
  description: The first four subsets of the WAB (Spontaneous Speech, Auditory verbal comprehension, Repetition, Naming and word finding) will be used to evaluate the participants' language ability impairments. A Chinese adapted version of WAB will be used. The scores from all four subsets will be calculated as an Aphasia Quotient (ranging from 0 to 100), with lower Aphasia Quotients indicating poorer language abilities.
  measure: Boston Diagnostic Aphasia Examination Severity Ratings
  time frame: baseline，end of the 3-week therapy，90 days after treatment initiation
  description: The Boston Diagnostic Aphasia Examination (BDAE) Severity Ratings is a clinical tool used to evaluate the severity and type of aphasia in individuals. The assessment includes four domains: communication abilities, language content, speech sound production and response abilities.BDAE severity ratings range from level 0 to level 5, with lower scores indicating more severe aphasia.
  measure: Token test
  time frame: baseline，end of the 3-week therapy，90 days after treatment initiation
  description: The Token Test is a language assessment tool used to evaluate a person's ability to understand spoken language and follow instructions. Each correct response in each task is awarded one point, typically. Different point values may be assigned based on the complexity of the task. The total score is calculated by adding up the accumulated scores across all tasks. The total scores range from 0 to 36, with higher scores indicating better language abilities.
  measure: Chinese-version Stroke and Aphasia Quality of Life Scale 39-generic version (SAQOL-39g)
  time frame: baseline，end of the 3-week therapy，90 days after treatment initiation
  description: The SAQOL-39g is a quality of life assessment tool that is used to evaluate the impact of stroke and aphasia on a patient's quality of life. It consists of 39 items that cover a range of domains related to the patient's quality of life, such as communication, physical functioning, mood, and social support. The items are rated on a 5-point Likert scale ranging from "not at all" to "very much", with higher scores indicating better quality of life.
  arm group label: active cTBS group
  arm group type: Active Comparator
  description: active cTBS combined with speech language therapy
  arm group label: sham cTBS group
  arm group type: Sham Comparator
  description: sham cTBS combined with speech language therapy
  intervention type: Device
  intervention name: active continuous Theta Burst Stimulation
  description: Each patient will receive two 600-pulse cTBS stimulations per day, parted by a 15-minute rest period (a total of 1200 pulses daily), for 3-week treatment, with 5 consecutive workdays each week.
  arm group label: active cTBS group
  intervention type: Device
  intervention name: sham continuous Theta Burst Stimulation
  description: Each patient will receive two sham 600-pulse cTBS stimulations per day, parted by a 15-minute rest period (a total of 1200 pulses daily), for 3-week treatment, with 5 consecutive workdays each week.
  arm group label: sham cTBS group
  criteria: 
  gender: All
  minimum age: 35 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Hesheng Liu, PhD
  role: Study Chair
  affiliation: Changping Laboratory
  last name: Na Xu, PhD
  phone: 010-80726688
  email: naxu@cpl.ac.cn
  responsible party type: Sponsor
  mesh term: Stroke
  mesh term: Ischemic Stroke
  mesh term: Aphasia
  mesh term: Ischemia