<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/NCT03837548</url>
  </required_header>
  <id_info>
    <org_study_id>18027-2</org_study_id>
    <secondary_id>UMIN000032937</secondary_id>
    <nct_id>NCT03837548</nct_id>
  </id_info>
  <brief_title>A Study of Neurofeedback for the Treatment of Parkinson's Disease</brief_title>
  <official_title>A Phase 1 Double-Blind Crossover Comparative Study of Neurofeedback for the Treatment of Parkinson's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Osaka University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Japan Agency for Medical Research and Development</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Osaka University</source>
  <oversight_info>
    <has_dmc>No</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>
      This study aims to reveal relationship between brain activities and the symptoms of Parkinson&#xD;
      disease when a neurofeedback training was applied for them.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 1, 2019</start_date>
  <completion_date type="Anticipated">March 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">March 31, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Alteration of Brain Activities</measure>
    <time_frame>At the time Immediately following the training</time_frame>
    <description>measured by magnetoencephalography</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The raw score change from baseline in the Movement disorder society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part Ⅲ scores</measure>
    <time_frame>At the time Immediately following the training</time_frame>
    <description>MDS-UPDRS retains the four-scale structure with a reorganization of the various subscales. The scales are now titled; (Part I) nonmotor experiences of daily living (13 items), (Part II) motor experiences of daily living (13 items), (Part III) motor examination (18 items), and (Part IV) motor complications (six items). Each subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe.&#xD;
The total score is the sum of the subscale scores for Part III and ranges from 0 (no disability) to 132 (total dependence).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>Training with Neurofeedback</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>The other Training with Neurofeedback</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Training with Neurofeedback</intervention_name>
    <description>Neurofeedback the brain activities by Magnetoencephalography</description>
    <arm_group_label>Training with Neurofeedback</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>The other Training with Neurofeedback</intervention_name>
    <description>Neurofeedback the brain activities by Magnetoencephalography</description>
    <arm_group_label>The other Training with Neurofeedback</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects with age more than 20&#xD;
&#xD;
          -  Subjects obtained the consent&#xD;
&#xD;
          -  Subjects with Parkinson disease and healthy subjects&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The subjects who can not conduct the tasks&#xD;
&#xD;
          -  Subjects with severe illness&#xD;
&#xD;
          -  Subjects whom the experimenter think as in appropriate&#xD;
&#xD;
          -  Subjects with implantable devices such as pacemaker&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Takufumi Yanagisawa, Ph.D.</last_name>
    <phone>+81-6-6879-3652</phone>
    <email>tyanagisawa@nsurg.med.osaka-u.ac.jp</email>
  </overall_contact>
  <location>
    <facility>
      <name>Osaka University</name>
      <address>
        <city>Suita-City</city>
        <state>Osaka-fu</state>
        <zip>5650871</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Takufumi Yanagisawa, Ph.D.</last_name>
      <phone>+81-6-6879-3652</phone>
      <email>tyanagisawa@nsurg.med.osaka-u.ac.jp</email>
    </contact>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>February 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>September 10, 2019</last_update_submitted>
  <last_update_submitted_qc>September 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Parkinson's Disease</keyword>
  <keyword>Magnetoencephalography</keyword>
  <keyword>Neurofeedback</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</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/NCT03837548
org study id: 18027-2
secondary id: UMIN000032937
nct id: NCT03837548
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to reveal relationship between brain activities and the symptoms of Parkinson
      disease when a neurofeedback training was applied for them.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Alteration of Brain Activities
time frame: At the time Immediately following the training
description: measured by magnetoencephalography
measure: The raw score change from baseline in the Movement disorder society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part Ⅲ scores
time frame: At the time Immediately following the training
description: MDS-UPDRS retains the four-scale structure with a reorganization of the various subscales. The scales are now titled; (Part I) nonmotor experiences of daily living (13 items), (Part II) motor experiences of daily living (13 items), (Part III) motor examination (18 items), and (Part IV) motor complications (six items). Each subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe.
The total score is the sum of the subscale scores for Part III and ranges from 0 (no disability) to 132 (total dependence).
arm group label: Training with Neurofeedback
arm group type: Experimental
arm group label: The other Training with Neurofeedback
arm group type: Experimental
intervention type: Other
intervention name: Training with Neurofeedback
description: Neurofeedback the brain activities by Magnetoencephalography
arm group label: Training with Neurofeedback
intervention type: Other
intervention name: The other Training with Neurofeedback
description: Neurofeedback the brain activities by Magnetoencephalography
arm group label: The other Training with Neurofeedback
criteria: 
gender: All
minimum age: 20 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Takufumi Yanagisawa, Ph.D.
phone: +81-6-6879-3652
email: tyanagisawa@nsurg.med.osaka-u.ac.jp
facility: 
status: Recruiting
contact: 
country: Japan
responsible party type: Sponsor
mesh term: Parkinson Disease
sharing ipd: No