<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/NCT02214251</url>
  </required_header>
  <id_info>
    <org_study_id>CMUH103-REC2-017</org_study_id>
    <nct_id>NCT02214251</nct_id>
  </id_info>
  <brief_title>The Electrophysiological Investigation of Higher Level Neural Manifestations of Freezing of Gait in Parkinson's Disease Patient</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>China Medical University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Science Council, Taiwan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>China Medical University Hospital</source>
  <brief_summary>
    <textblock>
      We aim to investigate the higher level mechanism of gait disorders in PD patients by&#xD;
      ambulatory recording of electroencephalographic (EEG) and leg electromyographic (EMG) signals&#xD;
      during unconstrained walking. Independent component analysis will be conducted for signal&#xD;
      analysis. The connectivity among different brain regions will also be investigated. The PD&#xD;
      patients received deep brain stimulation will be recruited for the study. The local field&#xD;
      potentials recorded from sub-thalamic nuclei and/or PPN will be recorded concomitantly with&#xD;
      EEG and leg EMG signals during unconstrained walking in PD patients to assess the roles of&#xD;
      these deep structures in ambulation and their functional connectivity with other brain&#xD;
      regions during walking.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Gait disorder in Parkinson's disease (PD) contains several aspects including particularly the&#xD;
      slowness of walking and freezing of gait (FOG). These problems may sometimes cause fall of&#xD;
      patients and culminate in severe head injury and bony fracture. In this regard the&#xD;
      understanding of freezing of gait and other parkinsonian ambulatory disorders is important&#xD;
      for the management of patients. Previous electrophysiological studies of gait disorders were&#xD;
      majorly focused on the kinetic and kinematric measurements. How the higher level neural&#xD;
      structures including the cerebral cortex, basal ganglia, sub-thalamic nucleus or&#xD;
      pedunculopontine nucleus were involved in the gait processing are currently unknown. A recent&#xD;
      study by adopting movement related cortical potential (MRCP) recording to probe the PD&#xD;
      ambulatory disorders in freezing and non-freezing patients illustrated that PD patients with&#xD;
      FOG lost the relationship between stride length and the movement related potentials. Since&#xD;
      the study was performed in constrained condition and each trigger for MRCP did not guarantee&#xD;
      to be of freezing nature in FOG patients, the results cannot reflect the true manifestations&#xD;
      of gait freezing in PD patients. In the current proposal, we will perform concomitant&#xD;
      recording of the scalp electroencephagraphic and leg electromyographic signals during&#xD;
      unconstrained walking in normal subjects and PD with or without FOG. Independent component&#xD;
      analysis (ICA) will be conducted for analyzing the possible differences of patterns among the&#xD;
      three groups and within the FOG patients during the freezing and non-freezing phases. In&#xD;
      addition, the cortical effective connectivity among different cortical regions during&#xD;
      freezing and non-freezing phase will also be assessed. Since sub-thalamic nuclei and&#xD;
      pedunculopontine nucleus may be involved in the ambulatory circuitry, we will also&#xD;
      investigate this possibility in PD patients to be treated with deep brain stimulation. The&#xD;
      nuclear local field potentials will be recorded concomitantly with scalp&#xD;
      electroencephalographic signals and electromyographic signals during unconstrained signals.&#xD;
      ICA and event related de-synchronization analysis will be conducted to understand the roles&#xD;
      of these nuclei in walking. The effective connectivity of the deep nuclei and the cortical&#xD;
      regions will also be assessed to learn the functional set of ambulation. The pioneer&#xD;
      exploration of the higher level neural manifestations of walking will extend the spectrum&#xD;
      from conventional kinetic and kinematric gait analysis to peep how the central neural&#xD;
      circuitry operate in ambulation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">July 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recording of electroencephalographic (EEG) and electromyographic (EMG) signals during unconstrained walking.</measure>
    <time_frame>Baseline</time_frame>
    <description>Variables in gait analysis:1.Gait initiation; 2.Level walking; 3.Turning; 4.Gait termination.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Unified Parkinson's Disease Rating Scale (UPDRS)</measure>
    <time_frame>Baseline</time_frame>
    <description>The UPDRS score has three parts, part I (Mentation, Behavior and Mood), Part II (Activities of Daily Living) and Part III (Motor Examination). Each consisting of questions answered on a 0-4 point scale. The minimum total score possible is 0 and the maximum total score possible is 176. Higher scores indicating more severe symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The 39-item Parkinson's Disease Questionnaire (PDQ-39)</measure>
    <time_frame>Baseline</time_frame>
    <description>The PDQ-39 contains 39-items covering 8 discrete dimensions: mobility, activities of daily living, emotional well-being, stigma, social support, cognitions, communication, and bodily discomfort. Each question is scored on a 5-point scale and recoded to 0 to 4 for the analysis. The total score can range from 0 to 132 and with a higher score indicating more severe symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Fall Assessment Test of CMUH</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tinetti Performance Oriented Mobility Assessment (POMA)</measure>
    <time_frame>Baseline</time_frame>
    <description>The Tinetti assessment tool is an easily administered task-oriented test that measures an older adult's gait and balance abilities. The total score can range from 0 to 28 and with a lower score indicating more severe symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>New freezing of gait questionnaire (NFOG-Q)</measure>
    <time_frame>Baseline</time_frame>
    <description>The New Freezing of Gait Questionnaire (NFOG-Q) is a clinician-administered tool that aims to assess both the clinical aspects of FOG as well as its subsequent impairments on quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mini-Mental State Examination (MMSE)</measure>
    <time_frame>Baseline</time_frame>
    <description>MMSE consists of five sections (orientation, registration, attention-calculation, recall, and language) and results in a total possible score of 30, with higher scores indicating better function.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Parkinson's Disease</condition>
  <condition>Freezing of Gait</condition>
  <arm_group>
    <arm_group_label>PK-16CH EXG system</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PK-16CH EXG is a wireless physiological signal acquisition system for monitoring the bio-signals, such as EEG, ECG, and EMG. The system can concomitant EEG and EMG recording during ambulation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PK-16CH EXG system</intervention_name>
    <arm_group_label>PK-16CH EXG system</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients with PD will be diagnosed according to the Brain Bank criteria.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. impairment of cognition that leads unable to fully cooperate with the oral commands&#xD;
             during operation.&#xD;
&#xD;
          2. any moderate to severe medical disorders such as poor control of diabetic mellitus,&#xD;
             functional III or above congestive heart failure, or cancer with distant metastasis&#xD;
             etc.&#xD;
&#xD;
          3. severe mood disorders such as major depression.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>China Medical University Hospital/Neuro Depart</name>
      <address>
        <city>Taichung</city>
        <zip>40447</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>August 8, 2014</study_first_submitted>
  <study_first_submitted_qc>August 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 12, 2014</study_first_posted>
  <last_update_submitted>July 27, 2016</last_update_submitted>
  <last_update_submitted_qc>July 27, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 28, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>China Medical University Hospital</investigator_affiliation>
    <investigator_full_name>Chon-Haw Tsai</investigator_full_name>
    <investigator_title>The chief, Department of Neurology</investigator_title>
  </responsible_party>
  <keyword>Parkinson's disease</keyword>
  <keyword>freezing of gait</keyword>
  <keyword>movement disorders</keyword>
  <keyword>neuroscience</keyword>
  <keyword>neural</keyword>
  <keyword>mechanism</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</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/NCT02214251
org study id: CMUH103-REC2-017
nct id: NCT02214251
lead sponsor: 
collaborator: 
We aim to investigate the higher level mechanism of gait disorders in PD patients by
      ambulatory recording of electroencephalographic (EEG) and leg electromyographic (EMG) signals
      during unconstrained walking. Independent component analysis will be conducted for signal
      analysis. The connectivity among different brain regions will also be investigated. The PD
      patients received deep brain stimulation will be recruited for the study. The local field
      potentials recorded from sub-thalamic nuclei and/or PPN will be recorded concomitantly with
      EEG and leg EMG signals during unconstrained walking in PD patients to assess the roles of
      these deep structures in ambulation and their functional connectivity with other brain
      regions during walking.
Gait disorder in Parkinson's disease (PD) contains several aspects including particularly the
      slowness of walking and freezing of gait (FOG). These problems may sometimes cause fall of
      patients and culminate in severe head injury and bony fracture. In this regard the
      understanding of freezing of gait and other parkinsonian ambulatory disorders is important
      for the management of patients. Previous electrophysiological studies of gait disorders were
      majorly focused on the kinetic and kinematric measurements. How the higher level neural
      structures including the cerebral cortex, basal ganglia, sub-thalamic nucleus or
      pedunculopontine nucleus were involved in the gait processing are currently unknown. A recent
      study by adopting movement related cortical potential (MRCP) recording to probe the PD
      ambulatory disorders in freezing and non-freezing patients illustrated that PD patients with
      FOG lost the relationship between stride length and the movement related potentials. Since
      the study was performed in constrained condition and each trigger for MRCP did not guarantee
      to be of freezing nature in FOG patients, the results cannot reflect the true manifestations
      of gait freezing in PD patients. In the current proposal, we will perform concomitant
      recording of the scalp electroencephagraphic and leg electromyographic signals during
      unconstrained walking in normal subjects and PD with or without FOG. Independent component
      analysis (ICA) will be conducted for analyzing the possible differences of patterns among the
      three groups and within the FOG patients during the freezing and non-freezing phases. In
      addition, the cortical effective connectivity among different cortical regions during
      freezing and non-freezing phase will also be assessed. Since sub-thalamic nuclei and
      pedunculopontine nucleus may be involved in the ambulatory circuitry, we will also
      investigate this possibility in PD patients to be treated with deep brain stimulation. The
      nuclear local field potentials will be recorded concomitantly with scalp
      electroencephalographic signals and electromyographic signals during unconstrained signals.
      ICA and event related de-synchronization analysis will be conducted to understand the roles
      of these nuclei in walking. The effective connectivity of the deep nuclei and the cortical
      regions will also be assessed to learn the functional set of ambulation. The pioneer
      exploration of the higher level neural manifestations of walking will extend the spectrum
      from conventional kinetic and kinematric gait analysis to peep how the central neural
      circuitry operate in ambulation.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Recording of electroencephalographic (EEG) and electromyographic (EMG) signals during unconstrained walking.
time frame: Baseline
description: Variables in gait analysis:1.Gait initiation; 2.Level walking; 3.Turning; 4.Gait termination.
measure: Unified Parkinson's Disease Rating Scale (UPDRS)
time frame: Baseline
description: The UPDRS score has three parts, part I (Mentation, Behavior and Mood), Part II (Activities of Daily Living) and Part III (Motor Examination). Each consisting of questions answered on a 0-4 point scale. The minimum total score possible is 0 and the maximum total score possible is 176. Higher scores indicating more severe symptoms.
measure: The 39-item Parkinson's Disease Questionnaire (PDQ-39)
time frame: Baseline
description: The PDQ-39 contains 39-items covering 8 discrete dimensions: mobility, activities of daily living, emotional well-being, stigma, social support, cognitions, communication, and bodily discomfort. Each question is scored on a 5-point scale and recoded to 0 to 4 for the analysis. The total score can range from 0 to 132 and with a higher score indicating more severe symptoms.
measure: The Fall Assessment Test of CMUH
time frame: Baseline
measure: Tinetti Performance Oriented Mobility Assessment (POMA)
time frame: Baseline
description: The Tinetti assessment tool is an easily administered task-oriented test that measures an older adult's gait and balance abilities. The total score can range from 0 to 28 and with a lower score indicating more severe symptoms.
measure: New freezing of gait questionnaire (NFOG-Q)
time frame: Baseline
description: The New Freezing of Gait Questionnaire (NFOG-Q) is a clinician-administered tool that aims to assess both the clinical aspects of FOG as well as its subsequent impairments on quality of life.
measure: Mini-Mental State Examination (MMSE)
time frame: Baseline
description: MMSE consists of five sections (orientation, registration, attention-calculation, recall, and language) and results in a total possible score of 30, with higher scores indicating better function.
arm group label: PK-16CH EXG system
arm group type: Experimental
description: PK-16CH EXG is a wireless physiological signal acquisition system for monitoring the bio-signals, such as EEG, ECG, and EMG. The system can concomitant EEG and EMG recording during ambulation.
intervention type: Device
intervention name: PK-16CH EXG system
arm group label: PK-16CH EXG system
criteria: 
gender: All
minimum age: 20 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: China Medical University Hospital
investigator full name: Chon-Haw Tsai
investigator title: The chief, Department of Neurology
mesh term: Parkinson Disease