xml: <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/NCT05998486</url>
    </required_header>
    <id_info>
      <org_study_id>ARM-Tremor</org_study_id>
      <nct_id>NCT05998486</nct_id>
    </id_info>
    <brief_title>Detecting the Rest Tremor Associated With Parkinson's Disease Using Analysis of the Muscle Contractions Rhythmicity</brief_title>
    <acronym>TREMORHYTHM</acronym>
    <official_title>Detecting the Rest Tremor Associated With Parkinson's Disease Using Analysis of the Muscle Contractions Rhythmicity</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Henri Mondor University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Henri Mondor University Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Resting tremors associated with Parkinson's disease (PD) remains difficult to quantify and&#xD;
        track during disease progression. This study propose to explore the rhythmicity of distal&#xD;
        muscle contractions in the upper limb to characterize resting tremor and discriminate it from&#xD;
        cerebellar tremor (CT) based on the frequency spectrum of the EMG signal.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This retrospective study analyzed surface EMG recordings of wrist flexor-pronators and&#xD;
        extensor-supinators from patients with PD or CT bilaterally in five 10-second conditions:&#xD;
        rest with contralateral motor distraction, symmetrical arms extended forward posture with&#xD;
        hands pronated, semi-pronation, supination, and elbows flexed with hands pronated. The&#xD;
        rhythmicity index (RI) is calculated from the ratio of the area of the maximum power peak to&#xD;
        the total area of the spectrum between 1.5-12Hz.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 3, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 30, 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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>rhythmicity index</measure>
      <time_frame>10 seconds</time_frame>
      <description>The rhythmicity index (RI) is calculated from the ratio of the area of the maximum power peak to the total area of the spectrum between 1.5-12Hz.</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Parkinson</condition>
    <condition>Cerebellar Tumor</condition>
    <condition>Rest Tremor</condition>
    <condition>Diagnoses Disease</condition>
    <condition>Movement; Abnormal, Involuntary</condition>
    <arm_group>
      <arm_group_label>Tremor of rest</arm_group_label>
      <description>Patient with a diagnosis of Parkinson's disease and who performed surface EMG recordings of wrist flexor-pronators and extensor-supinators analysis in Laboratories</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cerebellar tremor</arm_group_label>
      <description>Patient with a diagnosis of cerebellar tremor and who performed surface EMG recordings of wrist flexor-pronators and extensor-supinators analysis in Laboratories</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>EMG in wrist flexor-pronators and extensor-supinators</intervention_name>
      <description>The subject is asked to perform a series of tasks: resting posture, symmetrical posture arms forward, unilateral distal movement. Each task lasts 10 seconds.</description>
      <arm_group_label>Cerebellar tremor</arm_group_label>
      <arm_group_label>Tremor of rest</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with Parkinson's disease or cerebellar tremor diagnosis.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  patient who performed surface EMG recordings of wrist flexor-pronators and&#xD;
               extensor-supinators in Laboratories;&#xD;
  &#xD;
            -  diagnosis of Parkinson's disease or cerebellar tremor.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Botulinium toxin injection in upper limb during a delay of 3 months before surface EMG&#xD;
               recordings;&#xD;
  &#xD;
            -  Levodopa drugs administrated during a delay of 12 hours before surface EMG recordings;&#xD;
  &#xD;
            -  Tremor-favour drugs administrated during a delay of 30 days before surface EMG&#xD;
               recordings;&#xD;
  &#xD;
            -  Presence of an other neurologic disease or of any disease associated with motor&#xD;
               disorders in upper limb.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Emilie Hutin</last_name>
      <role>Principal Investigator</role>
      <affiliation>Henri Mondor University Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Emilie Hutin, PhD</last_name>
      <phone>+33149812549</phone>
      <email>emilie.hutin@aphp.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Emilie Hutin</last_name>
      <email>emilie.hutin@aphp.fr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Laboratoire Analyse et Restauration du Mouvement</name>
        <address>
          <city>Créteil</city>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Emilie Hutin, PhD</last_name>
        <phone>+33149812549</phone>
        <email>emilie.hutin@aphp.fr</email>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Henri Mondor University Hospital</investigator_affiliation>
      <investigator_full_name>Emilie Hutin</investigator_full_name>
      <investigator_title>Co-director of laboratory</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cerebellar Neoplasms</mesh_term>
      <mesh_term>Parkinson Disease</mesh_term>
      <mesh_term>Tremor</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05998486
  org study id: ARM-Tremor
  nct id: NCT05998486
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Resting tremors associated with Parkinson's disease (PD) remains difficult to quantify and
        track during disease progression. This study propose to explore the rhythmicity of distal
        muscle contractions in the upper limb to characterize resting tremor and discriminate it from
        cerebellar tremor (CT) based on the frequency spectrum of the EMG signal.
  This retrospective study analyzed surface EMG recordings of wrist flexor-pronators and
        extensor-supinators from patients with PD or CT bilaterally in five 10-second conditions:
        rest with contralateral motor distraction, symmetrical arms extended forward posture with
        hands pronated, semi-pronation, supination, and elbows flexed with hands pronated. The
        rhythmicity index (RI) is calculated from the ratio of the area of the maximum power peak to
        the total area of the spectrum between 1.5-12Hz.
  observational model: Cohort
  time perspective: Retrospective
  measure: rhythmicity index
  time frame: 10 seconds
  description: The rhythmicity index (RI) is calculated from the ratio of the area of the maximum power peak to the total area of the spectrum between 1.5-12Hz.
  arm group label: Tremor of rest
  description: Patient with a diagnosis of Parkinson's disease and who performed surface EMG recordings of wrist flexor-pronators and extensor-supinators analysis in Laboratories
  arm group label: Cerebellar tremor
  description: Patient with a diagnosis of cerebellar tremor and who performed surface EMG recordings of wrist flexor-pronators and extensor-supinators analysis in Laboratories
  intervention type: Diagnostic Test
  intervention name: EMG in wrist flexor-pronators and extensor-supinators
  description: The subject is asked to perform a series of tasks: resting posture, symmetrical posture arms forward, unilateral distal movement. Each task lasts 10 seconds.
  arm group label: Cerebellar tremor
  arm group label: Tremor of rest
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 100 Years
  healthy volunteers: No
  last name: Emilie Hutin
  role: Principal Investigator
  affiliation: Henri Mondor University Hospital
  last name: Emilie Hutin, PhD
  phone: +33149812549
  email: emilie.hutin@aphp.fr
  last name: Emilie Hutin
  email: emilie.hutin@aphp.fr
  facility: 
  status: Recruiting
  contact: 
  country: France
  responsible party type: Principal Investigator
  investigator affiliation: Henri Mondor University Hospital
  investigator full name: Emilie Hutin
  investigator title: Co-director of laboratory
  mesh term: Cerebellar Neoplasms
  mesh term: Parkinson Disease
  mesh term: Tremor
  sharing ipd: No