<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/NCT03279640</url>
  </required_header>
  <id_info>
    <org_study_id>2013-06-002</org_study_id>
    <nct_id>NCT03279640</nct_id>
  </id_info>
  <brief_title>Effects of Brain Network by Simultaneous Dual-mode Stimulation in Subacute Stroke Patients</brief_title>
  <official_title>Investigation for Individualized Noninvasive Neuromodulation in Neurorehabilitation of Brain Disease: Longitudinal Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Samsung Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Samsung Medical Center</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>
      Repetitive transcranial magnetic stimulation (rTMS) or transcranial direct current&#xD;
      stimulation (tDCS) has been used for the modulation of stroke patients' motor function by&#xD;
      altering the cortical excitability. Recently, more challenging approaches, such as&#xD;
      stimulation of two or more sites or use of dual modality have been studied in stroke&#xD;
      patients. In this study, simultaneous stimulation using both rTMS and tDCS (dual-mode&#xD;
      stimulation) over bilateral primary motor cortices (M1s) was investigated to compare its&#xD;
      modulatory effects with single rTMS stimulation in subacute stroke patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Investigators assessed each patient's motor function using the Fugl-Meyer Assessment (FMA)&#xD;
      score and acquired their resting-state fMRI (rs-fMRI) data at two times: prior to stimulation&#xD;
      and 2 months after stimulation. Changes in rs-fMRI network measures were investigated between&#xD;
      groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2014</start_date>
  <completion_date type="Actual">February 28, 2017</completion_date>
  <primary_completion_date type="Actual">February 28, 2017</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Neuroimaging Assessment</measure>
    <time_frame>Change from baseline resting-state brain network at 8 weeks after intervention</time_frame>
    <description>Resting-state fMRI</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Stroke</condition>
  <condition>Motor Disorder</condition>
  <arm_group>
    <arm_group_label>Dual-mode stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>rTMS on ipsilesional M1 + tDCS on contralesional M1&#xD;
10 Hz of rTMS was applied over the ipsilesional M1 for 20 minutes with simultaneous application of cathodal tDCS on the contralesional M1.&#xD;
Each participant's total FMA score is assessed and their resting-state fMRI data at two times: prior to stimulation (pre-stimulation) and 2 months after stimulation (post-stimulation) are acquired.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Single stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>rTMS on ipsilesional M1&#xD;
10 Hz of rTMS over the ipsilesional M1 was applied for 20 minutes.&#xD;
Each participant's total FMA score is assessed and their resting-state fMRI data at two times: prior to stimulation (pre-stimulation) and 2 months after stimulation (post-stimulation) are acquired.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>rTMS on ipsilesional M1</intervention_name>
    <arm_group_label>Dual-mode stimulation</arm_group_label>
    <arm_group_label>Single stimulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>tDCS on contralesional M1</intervention_name>
    <arm_group_label>Dual-mode stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  First-ever stroke patients&#xD;
&#xD;
          -  Subacute stage (less than 4 weeks)&#xD;
&#xD;
          -  Total Fugl-Meyer Assessment (FMA) score under 84&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Major active neurological disease or psychiatric disease&#xD;
&#xD;
          -  A history of seizure&#xD;
&#xD;
          -  Metallic implants in their brain&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yun-Hee Kim, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Samsung Medical Center</affiliation>
  </overall_official>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>September 10, 2017</study_first_submitted>
  <study_first_submitted_qc>September 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>September 12, 2017</last_update_submitted>
  <last_update_submitted_qc>September 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Motor Network</keyword>
  <keyword>Resting-state fMRI</keyword>
  <keyword>Repetitive Transcranial Magnetic Stimulation</keyword>
  <keyword>Transcranial Direct Current Stimulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Motor Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 10, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/40/NCT03279640/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03279640
org study id: 2013-06-002
nct id: NCT03279640
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Repetitive transcranial magnetic stimulation (rTMS) or transcranial direct current
      stimulation (tDCS) has been used for the modulation of stroke patients' motor function by
      altering the cortical excitability. Recently, more challenging approaches, such as
      stimulation of two or more sites or use of dual modality have been studied in stroke
      patients. In this study, simultaneous stimulation using both rTMS and tDCS (dual-mode
      stimulation) over bilateral primary motor cortices (M1s) was investigated to compare its
      modulatory effects with single rTMS stimulation in subacute stroke patients.
Investigators assessed each patient's motor function using the Fugl-Meyer Assessment (FMA)
      score and acquired their resting-state fMRI (rs-fMRI) data at two times: prior to stimulation
      and 2 months after stimulation. Changes in rs-fMRI network measures were investigated between
      groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Neuroimaging Assessment
time frame: Change from baseline resting-state brain network at 8 weeks after intervention
description: Resting-state fMRI
arm group label: Dual-mode stimulation
arm group type: Experimental
description: rTMS on ipsilesional M1 + tDCS on contralesional M1
10 Hz of rTMS was applied over the ipsilesional M1 for 20 minutes with simultaneous application of cathodal tDCS on the contralesional M1.
Each participant's total FMA score is assessed and their resting-state fMRI data at two times: prior to stimulation (pre-stimulation) and 2 months after stimulation (post-stimulation) are acquired.
arm group label: Single stimulation
arm group type: Experimental
description: rTMS on ipsilesional M1
10 Hz of rTMS over the ipsilesional M1 was applied for 20 minutes.
Each participant's total FMA score is assessed and their resting-state fMRI data at two times: prior to stimulation (pre-stimulation) and 2 months after stimulation (post-stimulation) are acquired.
intervention type: Device
intervention name: rTMS on ipsilesional M1
arm group label: Dual-mode stimulation
arm group label: Single stimulation
intervention type: Device
intervention name: tDCS on contralesional M1
arm group label: Dual-mode stimulation
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Yun-Hee Kim, MD, PhD
role: Principal Investigator
affiliation: Samsung Medical Center
responsible party type: Sponsor
mesh term: Motor Disorders
sharing ipd: No
provided document: 