<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/NCT04405479</url>
  </required_header>
  <id_info>
    <org_study_id>EK-VP/23/0/2014</org_study_id>
    <nct_id>NCT04405479</nct_id>
  </id_info>
  <brief_title>Resting Postural Tremor in Multiple Sclerosis</brief_title>
  <official_title>Spectral Analyses of Resting Postural Tremor Measured by Accelerometer and Gyroscope as a Predictive Tool of Multiple Sclerosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Charles University, Czech Republic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Charles University, Czech Republic</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Early diagnosis is a key factor for effective treatment of multiple sclerosis. Accelerometer&#xD;
      and gyroscope measurement of tremor could screen potential motor control dysfunction and&#xD;
      predict a risk for development of multiple sclerosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is to test whether specially developed accelerometer and gyroscope can&#xD;
      differentiate pattern of resting postural tremor in healthy and people with multiple&#xD;
      sclerosis.&#xD;
&#xD;
      Spectral analysis and the correlation of the average signal spectra will be computed.&#xD;
      Moreover, categorization based on the tremor component according to the maximum likelihood&#xD;
      estimation will be done.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 1, 2021</start_date>
  <completion_date type="Anticipated">December 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">October 28, 2023</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>Tremor</measure>
    <time_frame>baseline</time_frame>
    <description>accelerometer (1 m·s-2)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hand grip strength</measure>
    <time_frame>baseline</time_frame>
    <description>Hand dynamometer JAMA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hand and arm function</measure>
    <time_frame>baseline</time_frame>
    <description>Nine Hole Peg Test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychomotor processing speed</measure>
    <time_frame>baseline</time_frame>
    <description>Coin Rotation Task</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>Patients with multiple sclerosis</arm_group_label>
    <description>MS patients will be chosen by an independent neurologist.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy volunteers</arm_group_label>
    <description>Healthy controls will be paired by age and sex with MS patients.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Examination of tremor and upper hand functions</intervention_name>
    <description>Participants will be only examined. They will not undergo any intervention.</description>
    <arm_group_label>Healthy volunteers</arm_group_label>
    <arm_group_label>Patients with multiple sclerosis</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        People with MS and healthy volunteers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Group 1:&#xD;
&#xD;
          -  Definite diagnosis of MS&#xD;
&#xD;
          -  prevailed motor deficit of upper extremities, but without visible tremor&#xD;
&#xD;
          -  stable clinical status in the preceding 3 months&#xD;
&#xD;
          -  Expanded Disability Status Scale score (EDSS) ≥ 2 ≤ 7.5, and&#xD;
&#xD;
          -  no corticosteroid therapy in the preceding month&#xD;
&#xD;
        Group 2:&#xD;
&#xD;
          -  Healthy volunteers in the age of 20-70 years will be employed&#xD;
&#xD;
          -  There will be defined as persons without any neurological disease diagnose at the time&#xD;
             of the measurement.&#xD;
&#xD;
        Exclusion Criteria (both groups):&#xD;
&#xD;
        Patients with factors disturbing mobility (e.g. stroke, pregnancy, fractures) were excluded&#xD;
        from the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kamila Řasová, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Third Faculty of Mecicine, Charles Univerzity</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kamila Řasová, Ph.D.</last_name>
    <phone>+420604511416</phone>
    <email>kamila.rasova@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of neurology</name>
      <address>
        <city>Prague</city>
        <zip>100 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ivana Stetkarova, prof MD PhD</last_name>
      <phone>+420197170</phone>
      <email>ivana.stetkarova@fnkv.cz</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Deparment of revmatology and rehabilitation</name>
      <address>
        <city>Prague</city>
        <zip>140 59</zip>
        <country>Czechia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tom Philipp, M.D., Ph.D.</last_name>
      <phone>+420737273589</phone>
      <email>tom.philipp@ftn.cz</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Kamila Řasová</name>
      <address>
        <city>Praha</city>
        <zip>128 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kamila Řasová, Ph.D.</last_name>
      <phone>+420604511416</phone>
      <email>kamila.rasova@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Natalia Hrušková</last_name>
      <phone>+420702836959</phone>
      <email>natalia0087@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Czechia</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>February 9, 2023</last_update_submitted>
  <last_update_submitted_qc>February 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Charles University, Czech Republic</investigator_affiliation>
    <investigator_full_name>Kamila Řasová</investigator_full_name>
    <investigator_title>associate professor PhDr. Kamila Řasová, Ph.D.</investigator_title>
  </responsible_party>
  <keyword>Tremor</keyword>
  <keyword>Accelerometer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Tremor</mesh_term>
    <mesh_term>Sclerosis</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/NCT04405479
org study id: EK-VP/23/0/2014
nct id: NCT04405479
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Early diagnosis is a key factor for effective treatment of multiple sclerosis. Accelerometer
      and gyroscope measurement of tremor could screen potential motor control dysfunction and
      predict a risk for development of multiple sclerosis.
The aim of this study is to test whether specially developed accelerometer and gyroscope can
      differentiate pattern of resting postural tremor in healthy and people with multiple
      sclerosis.

      Spectral analysis and the correlation of the average signal spectra will be computed.
      Moreover, categorization based on the tremor component according to the maximum likelihood
      estimation will be done.
observational model: Cohort
time perspective: Prospective
measure: Tremor
time frame: baseline
description: accelerometer (1 m·s-2)
measure: Hand grip strength
time frame: baseline
description: Hand dynamometer JAMA
measure: Hand and arm function
time frame: baseline
description: Nine Hole Peg Test
measure: Psychomotor processing speed
time frame: baseline
description: Coin Rotation Task
arm group label: Patients with multiple sclerosis
description: MS patients will be chosen by an independent neurologist.
arm group label: Healthy volunteers
description: Healthy controls will be paired by age and sex with MS patients.
intervention type: Behavioral
intervention name: Examination of tremor and upper hand functions
description: Participants will be only examined. They will not undergo any intervention.
arm group label: Healthy volunteers
arm group label: Patients with multiple sclerosis
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kamila Řasová, Ph.D.
role: Principal Investigator
affiliation: Third Faculty of Mecicine, Charles Univerzity
last name: Kamila Řasová, Ph.D.
phone: +420604511416
email: kamila.rasova@gmail.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
country: Czechia
responsible party type: Principal Investigator
investigator affiliation: Charles University, Czech Republic
investigator full name: Kamila Řasová
investigator title: associate professor PhDr. Kamila Řasová, Ph.D.
mesh term: Multiple Sclerosis
mesh term: Tremor
mesh term: Sclerosis
sharing ipd: No