<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/NCT03839810</url>
  </required_header>
  <id_info>
    <org_study_id>MOST107-2314-B-010-050</org_study_id>
    <nct_id>NCT03839810</nct_id>
  </id_info>
  <brief_title>Stochastic Resonance Stimulation in Brain Plasticity and Post Stroke Motor Recovery</brief_title>
  <official_title>Effects of Stochastic Resonance Electrical Stimulation on Post Stroke Cortical Plasticity and Motor Function Recovery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Yang Ming University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Taipei Veterans General Hospital, Taiwan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National Yang Ming 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>
      This study evaluates the effectiveness of stochastic resonance electric stimulation on&#xD;
      neuromuscular control and proprioception in healthy and individuals with stroke.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Stroke is one of the leading causes of motor disability. The main intervention strategy in&#xD;
      stroke rehabilitation is to induce cortical plasticity for motor re-learning.&#xD;
&#xD;
      It has been demonstrated that electrical stimulation applied to the periphery can elicit&#xD;
      abundant sensory afferent inputs to enhance excitability and activation area in the&#xD;
      sensorimotor cortex. Recent evidence suggested that a new type of electrical stimulation&#xD;
      pattern, stochastic resonance stimulation, is capable of efficiently enhancing the activation&#xD;
      of peripheral and central nervous system. Therefore, the purpose of this study are to&#xD;
      identify the effects of stochastic resonance electrical stimulation on neuromuscular control&#xD;
      and proprioception, and to investigate the effectiveness of combining stochastic resonance&#xD;
      electrical stimulation with rehabilitation program on post stroke motor function recovery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 1, 2018</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2019</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>EEG</measure>
    <time_frame>baseline and one minute after stimulation</time_frame>
    <description>we will calculate power spectral and see whether change in the alpha, beta, theta band</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fugl-Meyer Assessment for Upper Extremity</measure>
    <time_frame>baseline and one minute after stimulation</time_frame>
    <description>changes in upper extremity function of the stroke subjects</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>force deviation</measure>
    <time_frame>baseline and one minute after stimulation</time_frame>
    <description>we first calculated the absolute value of the difference between force output and the value of 50%MVC for each data point and then calculated the average force deviation value by dividing the sum of all values by the number of data points</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>joint angle</measure>
    <time_frame>baseline and one minute after stimulation</time_frame>
    <description>ABS(the subject perform degree - target degree )</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>muscle activation</measure>
    <time_frame>baseline and one minute after stimulation</time_frame>
    <description>EMG changes in stimulation</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Stroke, Ischemic</condition>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>stochastic resonance</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>stochastic resonance electrical stimulation is applied to the upper extremity during the subjects perform upper extremity motor function.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sham stimulation</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>sham electrical stimulation (same electrode location, but no electrical current is applied) is applied to the upper extremity during the subjects perform upper extremity motor function.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>stochastic resonance electrical stimulation</intervention_name>
    <description>stochastic resonance electrical stimulation is applied in the upper extremity during motor functional training.&#xD;
Sham comparator group uses sham stimulation - same electrode location, but no electrical current is applied during motor functional training</description>
    <arm_group_label>sham stimulation</arm_group_label>
    <arm_group_label>stochastic resonance</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        In first stage&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
        healthy adults without history of neurological disorders or limitation in range of motion&#xD;
        for thumb ﬂexion&#xD;
&#xD;
        In the second stage&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          1. first-ever cerebral cortical region involved chronic stroke, onset over a month&#xD;
&#xD;
          2. able to perform active grasp on the affected side with the scores of manual muscle&#xD;
             test at least two points&#xD;
&#xD;
          3. at stable medical condition for intervention confirmed by a specialized physician.&#xD;
&#xD;
        The exclusion criteria were&#xD;
&#xD;
          1. history of other neurological disorders&#xD;
&#xD;
          2. cognitive impairment (Mini-Mental State Examination score &lt; 24, MMSE)29&#xD;
&#xD;
          3. unable to follow instructions&#xD;
&#xD;
          4. contraindications of ES&#xD;
&#xD;
          5. under 20 years old.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Li-Wei Chou, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Yang Ming University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Li-Wei Chou, PhD</last_name>
    <phone>+886228267092</phone>
    <email>lwchou@ym.edu.tw</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Shiang-Lin Hou</last_name>
    <phone>+886988563887</phone>
    <email>g30622007@gm.ym.edu.tw</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>National Yang-Ming University</name>
      <address>
        <city>Taipei</city>
        <zip>112</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Li-Wei Chou, PhD</last_name>
      <phone>+88628267092</phone>
      <email>lwchou@ym.edu.tw</email>
    </contact>
    <contact_backup>
      <last_name>Shiang-Lin Hou</last_name>
      <phone>+886988563887</phone>
      <email>g30622007@gm.ym.edu.tw</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 17, 2019</study_first_submitted>
  <study_first_submitted_qc>February 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>February 11, 2019</last_update_submitted>
  <last_update_submitted_qc>February 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>stochastic resonance</keyword>
  <keyword>proprioception</keyword>
  <keyword>motor control</keyword>
  <keyword>motor recovery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Ischemic Stroke</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/NCT03839810
org study id: MOST107-2314-B-010-050
nct id: NCT03839810
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the effectiveness of stochastic resonance electric stimulation on
      neuromuscular control and proprioception in healthy and individuals with stroke.
Stroke is one of the leading causes of motor disability. The main intervention strategy in
      stroke rehabilitation is to induce cortical plasticity for motor re-learning.

      It has been demonstrated that electrical stimulation applied to the periphery can elicit
      abundant sensory afferent inputs to enhance excitability and activation area in the
      sensorimotor cortex. Recent evidence suggested that a new type of electrical stimulation
      pattern, stochastic resonance stimulation, is capable of efficiently enhancing the activation
      of peripheral and central nervous system. Therefore, the purpose of this study are to
      identify the effects of stochastic resonance electrical stimulation on neuromuscular control
      and proprioception, and to investigate the effectiveness of combining stochastic resonance
      electrical stimulation with rehabilitation program on post stroke motor function recovery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: EEG
time frame: baseline and one minute after stimulation
description: we will calculate power spectral and see whether change in the alpha, beta, theta band
measure: Fugl-Meyer Assessment for Upper Extremity
time frame: baseline and one minute after stimulation
description: changes in upper extremity function of the stroke subjects
measure: force deviation
time frame: baseline and one minute after stimulation
description: we first calculated the absolute value of the difference between force output and the value of 50%MVC for each data point and then calculated the average force deviation value by dividing the sum of all values by the number of data points
measure: joint angle
time frame: baseline and one minute after stimulation
description: ABS(the subject perform degree - target degree )
measure: muscle activation
time frame: baseline and one minute after stimulation
description: EMG changes in stimulation
arm group label: stochastic resonance
arm group type: Experimental
description: stochastic resonance electrical stimulation is applied to the upper extremity during the subjects perform upper extremity motor function.
arm group label: sham stimulation
arm group type: Sham Comparator
description: sham electrical stimulation (same electrode location, but no electrical current is applied) is applied to the upper extremity during the subjects perform upper extremity motor function.
intervention type: Other
intervention name: stochastic resonance electrical stimulation
description: stochastic resonance electrical stimulation is applied in the upper extremity during motor functional training.
Sham comparator group uses sham stimulation - same electrode location, but no electrical current is applied during motor functional training
arm group label: sham stimulation
arm group label: stochastic resonance
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Li-Wei Chou, PhD
role: Principal Investigator
affiliation: National Yang Ming University
last name: Li-Wei Chou, PhD
phone: +886228267092
email: lwchou@ym.edu.tw
last name: Shiang-Lin Hou
phone: +886988563887
email: g30622007@gm.ym.edu.tw
facility: 
status: Recruiting
contact: 
contact backup: 
country: Taiwan
responsible party type: Sponsor
mesh term: Stroke
mesh term: Ischemic Stroke