<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/NCT03243318</url>
  </required_header>
  <id_info>
    <org_study_id>KHMEPsUL2017</org_study_id>
    <nct_id>NCT03243318</nct_id>
  </id_info>
  <brief_title>Motor Evoked Potential in the Affected Upper Limb Predicts the Potential of Motor Recovery in Subacute Stroke Patients</brief_title>
  <official_title>Motor Evoked Potential in the Affected Upper Limb Predicts the Potential of Motor Recovery in Subacute Stroke Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Authority, Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Authority, Hong Kong</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Stroke is the third common cause of adult disability in dveloped countries. Early&#xD;
      identification of the potential for motor recovery is important to avoid 'learned disuse' and&#xD;
      to initiate appropriate therapy with achievable goals. The current cohort study focuses on&#xD;
      those patients with SAFE &lt;8 and using motor evoked potentials (MEPs) to improve on&#xD;
      prognostication of upper limb motor recovery among subacute stroke patients in a local stroke&#xD;
      population.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 11, 2017</start_date>
  <completion_date type="Actual">November 30, 2021</completion_date>
  <primary_completion_date type="Actual">October 31, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Action Research Arm Test</measure>
    <time_frame>Change of Baseline Action Research Arm Test at 12 weeks post-stroke</time_frame>
    <description>Upper limb functional test</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">32</enrollment>
  <condition>Stroke, Subacute</condition>
  <arm_group>
    <arm_group_label>Presence of motor evoked potentials</arm_group_label>
    <description>Those patients with Shoulder Abduction and Finger Extension (SAFE) score &lt;8/10 with the presence of motor evoked potentials elicited by TMS over the ipsilesional motor cortex</description>
  </arm_group>
  <arm_group>
    <arm_group_label>absence of motor evoked potentials</arm_group_label>
    <description>Those patients with Shoulder Abduction and Finger Extension (SAFE) score &lt;8/10 with the absence of motor evoked potentials elicited by TMS over the ipsilesional motor cortex</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>MEPs induced by TMS</intervention_name>
    <description>Using TMS induced MEPs over motor cortex of the affected side to predict motor recovery potentials</description>
    <arm_group_label>Presence of motor evoked potentials</arm_group_label>
    <arm_group_label>absence of motor evoked potentials</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subacute stroke patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  First stroke with hemiparesis or hemiplegia with SAFE &lt;8&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  contra-indication to TMS or MRI, history of seizure, pregnancy and mentally unfit to&#xD;
             understand the consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Rehabilitation, Kowloon Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>August 4, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>May 21, 2022</last_update_submitted>
  <last_update_submitted_qc>May 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 26, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Authority, Hong Kong</investigator_affiliation>
    <investigator_full_name>Eric Man Pun Yeung</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03243318
org study id: KHMEPsUL2017
nct id: NCT03243318
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Stroke is the third common cause of adult disability in dveloped countries. Early
      identification of the potential for motor recovery is important to avoid 'learned disuse' and
      to initiate appropriate therapy with achievable goals. The current cohort study focuses on
      those patients with SAFE <8 and using motor evoked potentials (MEPs) to improve on
      prognostication of upper limb motor recovery among subacute stroke patients in a local stroke
      population.
observational model: Cohort
time perspective: Prospective
measure: Action Research Arm Test
time frame: Change of Baseline Action Research Arm Test at 12 weeks post-stroke
description: Upper limb functional test
arm group label: Presence of motor evoked potentials
description: Those patients with Shoulder Abduction and Finger Extension (SAFE) score <8/10 with the presence of motor evoked potentials elicited by TMS over the ipsilesional motor cortex
arm group label: absence of motor evoked potentials
description: Those patients with Shoulder Abduction and Finger Extension (SAFE) score <8/10 with the absence of motor evoked potentials elicited by TMS over the ipsilesional motor cortex
intervention type: Diagnostic Test
intervention name: MEPs induced by TMS
description: Using TMS induced MEPs over motor cortex of the affected side to predict motor recovery potentials
arm group label: Presence of motor evoked potentials
arm group label: absence of motor evoked potentials
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: Hospital Authority, Hong Kong
investigator full name: Eric Man Pun Yeung
investigator title: Doctor
mesh term: Stroke
sharing ipd: No