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/NCT05973019</url>
    </required_header>
    <id_info>
      <org_study_id>230425</org_study_id>
      <nct_id>NCT05973019</nct_id>
    </id_info>
    <brief_title>rTMS Improves Functions in Spinocerebellar Ataxia</brief_title>
    <official_title>Repetitive Transcranial Magnetic Stimulation Improves Functional Performance in Spinocerebellar Ataxia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Changhua Christian Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Changhua Christian Hospital</source>
    <oversight_info>
      <has_dmc>Yes</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>
        Spinocerebellar ataxia (SCA) is a group of inherited brain disorders. SCA often result in&#xD;
        poor limb coordination. This study aims to discover the effects of repeated transcranial&#xD;
        magnetic stimulation (rTMS) on balance &amp; gait in SCA. The hypothesis of this study is that&#xD;
        rTMS might improve SCA limb functional performance.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        rTMS has been shown that improves walking speed and balance performance, however, the optimal&#xD;
        treatment protocols have not been approved. Past studies used different frequencies 1 Hz, 5&#xD;
        Hz and 10 Hz to improve functional performance. The results might be affected by the types of&#xD;
        SCA. In this study, we will focus on the SCA type 3 to assess the effects on high frequency&#xD;
        (10 Hz) of rTMS intervention.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>All subjects receive 12 times rTMS intervention</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Changes of International Cooperative Ataxia Rating Scale</measure>
      <time_frame>Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),</time_frame>
      <description>International Cooperative Ataxia Rating Scale (ICARS): quantify the level of impairment as a result of ataxia as related to hereditary ataxias. Disorders rated as subscales within the ICARS are: Postural and gait disturbances, Limb Ataxia, Dysarthria, and Oculomotor disorders.It translates the symptomatology of cerebellar ataxia into a scoring system out of 100.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes of SARA</measure>
      <time_frame>Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),</time_frame>
      <description>Scale for the Assessment and Rating of Ataxia (SARA): a tool for assessing ataxia. It has eight categories with accumulative score ranging from 0 (no ataxia) to 40 (most severe ataxia).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes of Berg Balance Scale</measure>
      <time_frame>Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),</time_frame>
      <description>Berg Balance Scale (BBS): a widely used assessment to determine a person's balance abilities. The test contains 14 simple tasks, scoring ranges from 0 to 56. The lower your score, the more at risk you are for losing your balance. The entire process takes about 20 minutes to complete.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes of Timed up and go</measure>
      <time_frame>Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),</time_frame>
      <description>Timed up and go (TUG): Patients wear their regular footwear and can use a walking aid, if needed. Begin by having the patient sit back in a standard arm chair and identify a line 3 meters, or 10 feet away, on the floor.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes of Center of pressure trajectory</measure>
      <time_frame>Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),</time_frame>
      <description>Center of pressure (COP): he trajectory of the COP, commonly known as a stabilogram, during static balance is frequently used to measure postural control. When standing still on a force platform, the COP is thought to be an indicator of the motor mechanisms involved in maintaining balance with opened-eyes or closed-eyes. Two trials for each condition were performed within 5 minutes.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes of Kinematic of Gait</measure>
      <time_frame>Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),</time_frame>
      <description>The joint angles of hip, knee, ankle are collected during walking in a 10 meters walkway.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes of Electromyography of Gait</measure>
      <time_frame>Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),</time_frame>
      <description>A wireless surface Electromyography (EMG) is used to collect lower extremities muscle activation signals during walking in a walkway.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Concentration of Neurofilament</measure>
      <time_frame>Baseline (T0), 12 days after first rTMS intervention (T2)</time_frame>
      <description>neurofilament proteins is the biomarkers of axonal damage in diseases affecting the central nervous system</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes of Mini-mental state examination</measure>
      <time_frame>Baseline (T0)</time_frame>
      <description>The mini-mental state examination (MMSE) is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. A score of 25 or higher is classed as normal. If the score is below 24, the result is usually considered to be abnormal, indicating possible cognitive impairment. In this study, it is used to rule out subjects who might have dementia.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Transcranial Magnetic Stimulation</condition>
    <condition>Spinocerebellar Ataxias</condition>
    <arm_group>
      <arm_group_label>rTMS with 10 Hz</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>6 times/per week for 2 weeks, total 12 times rTMS.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Repetitive Transcranial Magnetic Stimulation (rTMS)</intervention_name>
      <description>6 times/per week for 2 weeks, total 12 times rTMS with 10 Hz.</description>
      <arm_group_label>rTMS with 10 Hz</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  SCA type 3&#xD;
  &#xD;
            -  independently walk with/without an assistive device&#xD;
  &#xD;
            -  SARA greater than 3&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Epilepsy history&#xD;
  &#xD;
            -  Unstable blood pressure&#xD;
  &#xD;
            -  Brain Trauma&#xD;
  &#xD;
            -  Alcoholism, drug abuse, antipsychotics drug use&#xD;
  &#xD;
            -  Metallic hardware (e.g. - cochlear implants, brain stimulators or electrodes, aneurysm&#xD;
               clips) anywhere in head.&#xD;
  &#xD;
            -  Dementia, depression&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Sen Yung Liu, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Changhua Christian Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sen Yung Liu, MD</last_name>
      <phone>88647238595</phone>
      <phone_ext>7427</phone_ext>
      <email>88925@cch.org.tw</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Changhua Christian Hospital</investigator_affiliation>
      <investigator_full_name>Sen-yung Liu</investigator_full_name>
      <investigator_title>Chief Medical Officer</investigator_title>
    </responsible_party>
    <keyword>rTMS</keyword>
    <keyword>SCA</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Ataxia</mesh_term>
      <mesh_term>Cerebellar Ataxia</mesh_term>
      <mesh_term>Spinocerebellar Ataxias</mesh_term>
      <mesh_term>Spinocerebellar Degenerations</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/NCT05973019
  org study id: 230425
  nct id: NCT05973019
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Spinocerebellar ataxia (SCA) is a group of inherited brain disorders. SCA often result in
        poor limb coordination. This study aims to discover the effects of repeated transcranial
        magnetic stimulation (rTMS) on balance & gait in SCA. The hypothesis of this study is that
        rTMS might improve SCA limb functional performance.
  rTMS has been shown that improves walking speed and balance performance, however, the optimal
        treatment protocols have not been approved. Past studies used different frequencies 1 Hz, 5
        Hz and 10 Hz to improve functional performance. The results might be affected by the types of
        SCA. In this study, we will focus on the SCA type 3 to assess the effects on high frequency
        (10 Hz) of rTMS intervention.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: All subjects receive 12 times rTMS intervention
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Changes of International Cooperative Ataxia Rating Scale
  time frame: Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),
  description: International Cooperative Ataxia Rating Scale (ICARS): quantify the level of impairment as a result of ataxia as related to hereditary ataxias. Disorders rated as subscales within the ICARS are: Postural and gait disturbances, Limb Ataxia, Dysarthria, and Oculomotor disorders.It translates the symptomatology of cerebellar ataxia into a scoring system out of 100.
  measure: Changes of SARA
  time frame: Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),
  description: Scale for the Assessment and Rating of Ataxia (SARA): a tool for assessing ataxia. It has eight categories with accumulative score ranging from 0 (no ataxia) to 40 (most severe ataxia).
  measure: Changes of Berg Balance Scale
  time frame: Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),
  description: Berg Balance Scale (BBS): a widely used assessment to determine a person's balance abilities. The test contains 14 simple tasks, scoring ranges from 0 to 56. The lower your score, the more at risk you are for losing your balance. The entire process takes about 20 minutes to complete.
  measure: Changes of Timed up and go
  time frame: Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),
  description: Timed up and go (TUG): Patients wear their regular footwear and can use a walking aid, if needed. Begin by having the patient sit back in a standard arm chair and identify a line 3 meters, or 10 feet away, on the floor.
  measure: Changes of Center of pressure trajectory
  time frame: Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),
  description: Center of pressure (COP): he trajectory of the COP, commonly known as a stabilogram, during static balance is frequently used to measure postural control. When standing still on a force platform, the COP is thought to be an indicator of the motor mechanisms involved in maintaining balance with opened-eyes or closed-eyes. Two trials for each condition were performed within 5 minutes.
  measure: Changes of Kinematic of Gait
  time frame: Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),
  description: The joint angles of hip, knee, ankle are collected during walking in a 10 meters walkway.
  measure: Changes of Electromyography of Gait
  time frame: Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),
  description: A wireless surface Electromyography (EMG) is used to collect lower extremities muscle activation signals during walking in a walkway.
  measure: Concentration of Neurofilament
  time frame: Baseline (T0), 12 days after first rTMS intervention (T2)
  description: neurofilament proteins is the biomarkers of axonal damage in diseases affecting the central nervous system
  measure: Changes of Mini-mental state examination
  time frame: Baseline (T0)
  description: The mini-mental state examination (MMSE) is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. A score of 25 or higher is classed as normal. If the score is below 24, the result is usually considered to be abnormal, indicating possible cognitive impairment. In this study, it is used to rule out subjects who might have dementia.
  arm group label: rTMS with 10 Hz
  arm group type: Experimental
  description: 6 times/per week for 2 weeks, total 12 times rTMS.
  intervention type: Device
  intervention name: Repetitive Transcranial Magnetic Stimulation (rTMS)
  description: 6 times/per week for 2 weeks, total 12 times rTMS with 10 Hz.
  arm group label: rTMS with 10 Hz
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Sen Yung Liu, MD
  role: Principal Investigator
  affiliation: Changhua Christian Hospital
  last name: Sen Yung Liu, MD
  phone: 88647238595
  phone ext: 7427
  email: 88925@cch.org.tw
  responsible party type: Principal Investigator
  investigator affiliation: Changhua Christian Hospital
  investigator full name: Sen-yung Liu
  investigator title: Chief Medical Officer
  mesh term: Ataxia
  mesh term: Cerebellar Ataxia
  mesh term: Spinocerebellar Ataxias
  mesh term: Spinocerebellar Degenerations