<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/NCT03277534</url>
  </required_header>
  <id_info>
    <org_study_id>104-2314-B-010-024</org_study_id>
    <nct_id>NCT03277534</nct_id>
  </id_info>
  <brief_title>Electrical Stimulation Combined With Motor Training on EEG-EMG Coherence and Motor Function in Individuals With Stroke</brief_title>
  <official_title>Effects of 8-week Sensory Electrical Stimulation Combined With Motor Training on EEG-EMG Coherence and Motor Function in Individuals With Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Yang Ming University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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 investigated whether electrical stimulation (ES) prior to a hand function training&#xD;
      session for a total of eight weeks can better improve neuromuscular control and hand function&#xD;
      in subacute stroke individuals and change electroencephalography-electromyography (EEG-EMG)&#xD;
      coherence, as compared to the control (sham ES).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects were randomly assigned into ES and control groups. Both groups received 20-minute&#xD;
      hand function training twice a week, and the ES group received 40-minute ES on the median&#xD;
      nerve of the affected side before each training session. The control group received sham ES -&#xD;
      electrodes were placed on the same location but no electric current was applied. EEG, EMG and&#xD;
      Fugl-Meyer Assessment (FMA) were collected before, at the 4th week, at the end of 8th week,&#xD;
      and 4 weeks after the end of intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 28, 2013</start_date>
  <completion_date type="Actual">January 4, 2017</completion_date>
  <primary_completion_date type="Actual">January 4, 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>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fugl-Meyer Assessment for Upper Extremity</measure>
    <time_frame>before intervention, four weeks after, at the end of the eight-week intervention and four weeks after the intervention period ended</time_frame>
    <description>evaluate changes in upper extremity function of the stroke subjects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>EEG-EMG coherence</measure>
    <time_frame>before intervention, four weeks after, at the end of the eight-week intervention and four weeks after the intervention period ended</time_frame>
    <description>evaluate changes in functional connectivity between motor cortex and active muscles</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Electrical stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Electrical stimulation</intervention_name>
    <description>sensory electrical stimulation was applied prior to upper limb functional training</description>
    <arm_group_label>Electrical stimulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sham electrical stimulation</intervention_name>
    <description>electrodes were placed on the same location as the Electrical stimulation condition, but no electric current was applied</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. first-ever cerebral cortical region involved chronic stroke, onset over a month,&#xD;
&#xD;
          2. able to perform active thumb flexion on the affected side with the scores of manual&#xD;
             muscle test at least two points, and&#xD;
&#xD;
          3. at stable medical condition for intervention&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. history of other neurological disorders,&#xD;
&#xD;
          2. cognitive impairment (Mini-Mental State Examination score &lt;24, MMSE),26&#xD;
&#xD;
          3. unable to follow orders,&#xD;
&#xD;
          4. contraindications of ES, and&#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>No</healthy_volunteers>
  </eligibility>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>September 6, 2017</last_update_submitted>
  <last_update_submitted_qc>September 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Yang Ming University</investigator_affiliation>
    <investigator_full_name>Li-Wei Chou</investigator_full_name>
    <investigator_title>Associate professor</investigator_title>
  </responsible_party>
  <keyword>electrical stimulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>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/NCT03277534
org study id: 104-2314-B-010-024
nct id: NCT03277534
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study investigated whether electrical stimulation (ES) prior to a hand function training
      session for a total of eight weeks can better improve neuromuscular control and hand function
      in subacute stroke individuals and change electroencephalography-electromyography (EEG-EMG)
      coherence, as compared to the control (sham ES).
Subjects were randomly assigned into ES and control groups. Both groups received 20-minute
      hand function training twice a week, and the ES group received 40-minute ES on the median
      nerve of the affected side before each training session. The control group received sham ES -
      electrodes were placed on the same location but no electric current was applied. EEG, EMG and
      Fugl-Meyer Assessment (FMA) were collected before, at the 4th week, at the end of 8th week,
      and 4 weeks after the end of intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Participant)
measure: Fugl-Meyer Assessment for Upper Extremity
time frame: before intervention, four weeks after, at the end of the eight-week intervention and four weeks after the intervention period ended
description: evaluate changes in upper extremity function of the stroke subjects
measure: EEG-EMG coherence
time frame: before intervention, four weeks after, at the end of the eight-week intervention and four weeks after the intervention period ended
description: evaluate changes in functional connectivity between motor cortex and active muscles
arm group label: Electrical stimulation
arm group type: Experimental
arm group label: Control
arm group type: Sham Comparator
intervention type: Other
intervention name: Electrical stimulation
description: sensory electrical stimulation was applied prior to upper limb functional training
arm group label: Electrical stimulation
intervention type: Other
intervention name: Sham electrical stimulation
description: electrodes were placed on the same location as the Electrical stimulation condition, but no electric current was applied
arm group label: Control
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: National Yang Ming University
investigator full name: Li-Wei Chou
investigator title: Associate professor
mesh term: Stroke