<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/NCT01731145</url>
  </required_header>
  <id_info>
    <org_study_id>D-1407-011-590</org_study_id>
    <nct_id>NCT01731145</nct_id>
  </id_info>
  <brief_title>Assessment of Tremor Using SNUMAP Motion Sensing System</brief_title>
  <acronym>SNUMAP</acronym>
  <official_title>Quantitative Assessment of Tremor Using Portable Six-axis (Tri-axial Accelerometer and Tri-axial Gyroscope) Motion Sensing System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Life Science Technology Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to record and measure tremor using portable six-axis (tri-axial&#xD;
      accelerometer and tri-axial gyroscope) motion sensing system.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      SNUMAP system is portable, finger-worn, battery powered device that contains MEMS&#xD;
      (micro-electro-mechanical system) hybrid motion sensor (three-axis accelerometer and&#xD;
      three-axis gyroscope). The SNUMAP device consists of a wrist module and finger module, which&#xD;
      attaches to an patients's finger and transmits three dimensional motions to a wrist module&#xD;
      for storage and further analysis. The aims of this study is to assess tremor severity using&#xD;
      tri-axial accelerometry and gyroscope to determine the reliability and the correlation with&#xD;
      clinical measurements.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>3-D Accelerometric and gyroscope variables measured</measure>
    <time_frame>1 day</time_frame>
    <description>Correlation between SNUMAP motion sensing system symptom assessment and clinical tremor rating scale (TRS) scores</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">187</enrollment>
  <condition>Tremor</condition>
  <arm_group>
    <arm_group_label>SNUMAP assessment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Uses SNUMAP motion sensing system to quantify tremor symptom.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SNUMAP</intervention_name>
    <description>Portable six-axis (tri-axial accelerometer and tri-axial gyroscope) motion sensing system</description>
    <arm_group_label>SNUMAP assessment</arm_group_label>
    <other_name>Hybrid (accelerometer and gyroscope)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 20-80 years&#xD;
&#xD;
          -  Patients with tremor (involuntary, rhythmic, oscillatory movement in one or more body&#xD;
             part)&#xD;
&#xD;
          -  Subject who signed an informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or nursing woman.&#xD;
&#xD;
          -  Comorbid neurologic illnesses that impact the ability to perform the study tasks.&#xD;
&#xD;
          -  Subjects with medical condition that in the opinion of the investigator would affect&#xD;
             his/her ability to participate in this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Beom S Jeon, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Neurology, Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>110-744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>November 15, 2012</study_first_submitted>
  <study_first_submitted_qc>November 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>July 7, 2015</last_update_submitted>
  <last_update_submitted_qc>July 7, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 8, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>BS Jeon</investigator_full_name>
    <investigator_title>Professor and Chairman, Department of Neurology</investigator_title>
  </responsible_party>
  <keyword>Tremor</keyword>
  <keyword>SNUMAP</keyword>
  <keyword>accelerometry</keyword>
  <keyword>gyroscope</keyword>
  <keyword>clinical rating scale</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tremor</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/NCT01731145
org study id: D-1407-011-590
nct id: NCT01731145
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to record and measure tremor using portable six-axis (tri-axial
      accelerometer and tri-axial gyroscope) motion sensing system.
SNUMAP system is portable, finger-worn, battery powered device that contains MEMS
      (micro-electro-mechanical system) hybrid motion sensor (three-axis accelerometer and
      three-axis gyroscope). The SNUMAP device consists of a wrist module and finger module, which
      attaches to an patients's finger and transmits three dimensional motions to a wrist module
      for storage and further analysis. The aims of this study is to assess tremor severity using
      tri-axial accelerometry and gyroscope to determine the reliability and the correlation with
      clinical measurements.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: 3-D Accelerometric and gyroscope variables measured
time frame: 1 day
description: Correlation between SNUMAP motion sensing system symptom assessment and clinical tremor rating scale (TRS) scores
arm group label: SNUMAP assessment
arm group type: Experimental
description: Uses SNUMAP motion sensing system to quantify tremor symptom.
intervention type: Device
intervention name: SNUMAP
description: Portable six-axis (tri-axial accelerometer and tri-axial gyroscope) motion sensing system
arm group label: SNUMAP assessment
other name: Hybrid (accelerometer and gyroscope)
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Beom S Jeon, M.D., Ph.D.
role: Principal Investigator
affiliation: Seoul National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: BS Jeon
investigator title: Professor and Chairman, Department of Neurology
mesh term: Tremor