<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/NCT01682668</url>
  </required_header>
  <id_info>
    <org_study_id>C11-40</org_study_id>
    <secondary_id>2012-A00225-38</secondary_id>
    <nct_id>NCT01682668</nct_id>
  </id_info>
  <brief_title>Subthalamic Nucleus, Akinesia and Parkinson's Disease</brief_title>
  <acronym>GB-MOV</acronym>
  <official_title>Role of the Subthalamic Nucleus in the Control of Movement: Physiopathology of Akinesia in Parkinson's Disease.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut National de la Santé Et de la Recherche Médicale, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut National de la Santé Et de la Recherche Médicale, France</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This program aims to understand the role of the subthalamic nucleus in the control of the&#xD;
      movement in healthy humans and patients with Parkinson's disease, how the STN dysfunction&#xD;
      contributes to akinesia and how the STN stimulation improves motor signs in PD patients .&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date>February 2013</start_date>
  <completion_date type="Anticipated">August 2024</completion_date>
  <primary_completion_date type="Anticipated">May 2024</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>Firing rate of the subthalamic neurons</measure>
    <time_frame>During surgery for bilateral STN stimulation</time_frame>
    <description>Changes in the neuronal activity of the STN before, during and after the execution of an arm movement</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evoked related potentials of the STN</measure>
    <time_frame>3-5 days after surgery for bilateral STN stimulation</time_frame>
    <description>Local-field potentials recordings with DBS electrodes when performing the execution of an arm movement or gait initiation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biomechanical parameters of gait initiation</measure>
    <time_frame>6 months</time_frame>
    <description>Gait initiation parameters by using a forceplate and EMG recordings</description>
  </secondary_outcome>
  <other_outcome>
    <measure>BOLD signal during fMRI</measure>
    <time_frame>1 month before surgery</time_frame>
    <description>Changes in the BOLD signal during fMRI with virtual imagery of movement</description>
  </other_outcome>
  <other_outcome>
    <measure>real-life assessment</measure>
    <time_frame>1 month after surgery</time_frame>
    <description>recording using the percept device</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Parkinson's Disease</condition>
  <arm_group>
    <arm_group_label>Frequency of subthalamic stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Comparison between healthy controls and PD patients (non-operable patients or who will be operated or already operated)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Bilateral subthalamic stimulation</intervention_name>
    <arm_group_label>Frequency of subthalamic stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria for patients who will be operated&#xD;
&#xD;
          1. Diagnosis of idiopathic Parkinson's disease (according to the criteria of the United&#xD;
             Kingdom Parkinson's Disease Society Brain Bank)&#xD;
&#xD;
          2. Age between 18 and 70;&#xD;
&#xD;
          3. Motor complications in the form of fluctuations in motor state or dyskinesias induced&#xD;
             by dopaminergic therapy, despite medical treatment optimum;&#xD;
&#xD;
          4. Other medical conditions that are stable or do not interfere with the procedure&#xD;
             proposed;&#xD;
&#xD;
          5. Excellent responsiveness to levodopa (UPDRS motor score improvement greater than 50%&#xD;
             in the acute levodopa test)&#xD;
&#xD;
          6. Brain MRI without abnormality&#xD;
&#xD;
          7. Normality of biological examinations&#xD;
&#xD;
          8. Person who has voluntarily and informedly agreed to participate in the study&#xD;
             (signature of a written consent)&#xD;
&#xD;
          9. Patient with social health insurance&#xD;
&#xD;
        Criteria for non-inclusion of Parkinsonian patients who will be operated&#xD;
&#xD;
          1. Contraindication to examinations necessary for inclusion&#xD;
&#xD;
          2. Evolutionary psychiatric pathology;&#xD;
&#xD;
          3. Dementia(MMS&lt;24/30);&#xD;
&#xD;
          4. Patients with a medical condition that makes surgery dangerous neuro-surgical;&#xD;
&#xD;
          5. Bleeding-promoting diseases and laboratory test abnormalities clotting;&#xD;
&#xD;
          6. Existence of contraindications to MRI (cardiac or neural pacemaker, clips&#xD;
             ferromagnetic surgeries, implants and metal objects, foreign bodies intraocular,&#xD;
             pregnancy, claustrophobia).&#xD;
&#xD;
          7. Taking drugs interfering with coagulation for 1 month before intervention.&#xD;
&#xD;
          8. Persons under guardianship, curatorship or any other administrative or judicial&#xD;
             measure deprivation of rights and liberty&#xD;
&#xD;
        Selection criteria for non-operated patients&#xD;
&#xD;
          1. Diagnosis of idiopathic Parkinson's disease (according to the criteria of the United&#xD;
             Kingdom Parkinson's Disease Society Brain Bank);&#xD;
&#xD;
          2. Age between 18 and 70;&#xD;
&#xD;
          3. Other medical conditions that are stable or do not interfere with the proposed&#xD;
             protocol;&#xD;
&#xD;
          4. Presence of axial signs (gait and/or balance disorders) no improved by&#xD;
             antiparkinsonian treatment&#xD;
&#xD;
          5. Brain MRI without notable abnormality&#xD;
&#xD;
          6. Normality of biological examinations&#xD;
&#xD;
          7. Person who has voluntarily and informedly agreed to participate in the study&#xD;
             (signature of a written consent)&#xD;
&#xD;
          8. Patient with social health insurance&#xD;
&#xD;
        Criteria for non-inclusion of non-operated patients&#xD;
&#xD;
          1. Contraindication to examinations necessary for inclusion&#xD;
&#xD;
          2. Progressive psychiatric pathology;&#xD;
&#xD;
          3. Dementia (MMS&lt;24/30);&#xD;
&#xD;
          4. Existence of contraindications to MRI (cardiac or neural pacemaker, clips&#xD;
             ferromagnetic surgeries, implants and metal objects, foreign bodies intraocular,&#xD;
             pregnancy, claustrophobia).&#xD;
&#xD;
          5. Persons under guardianship, curatorship or any other administrative or judicial&#xD;
             measuredeprivation of rights and liberty&#xD;
&#xD;
        Inclusion criteria for group 3 patients (already operated)&#xD;
&#xD;
          1. Diagnosis of idiopathic Parkinson's disease (according to the criteria of the United&#xD;
             Kingdom Parkinson's Disease Society Brain Bank);&#xD;
&#xD;
          2. Bilateral deep brain stimulation of the subthalamic nucleus for more than 1 year&#xD;
&#xD;
          3. Age between 18 and 70;&#xD;
&#xD;
          4. Person who has voluntarily and informedly agreed to participate in the study&#xD;
             (signature of a written consent)&#xD;
&#xD;
          5. Patient with social health insurance&#xD;
&#xD;
        Criteria for non-inclusion of Parkinsonian patients (already operated)&#xD;
&#xD;
          1. Contraindication to examinations necessary for inclusion&#xD;
&#xD;
          2. Evolutionary psychiatric pathology;&#xD;
&#xD;
          3. Dementia(MMS&lt;24/30);&#xD;
&#xD;
          4. Persons under guardianship, curatorship or any other administrative or judicial&#xD;
             measure deprivation of rights and liberty&#xD;
&#xD;
        Inclusion criteria for healthy subjects&#xD;
&#xD;
          1. Age between 18 and 70 years old&#xD;
&#xD;
          2. Normal neurological examination&#xD;
&#xD;
          3. Person who voluntarily and informedly agreed to participate in the study (signature of&#xD;
             a written consent)&#xD;
&#xD;
          4. Patient with social health insurance&#xD;
&#xD;
        Criteria for non-inclusion of healthy subjects&#xD;
&#xD;
          1. Persons under guardianship, curatorship or any other administrative or judicial&#xD;
             measure of deprivation of rights and freedom&#xD;
&#xD;
          2. Existence of neurological, orthopedic or psychiatric history&#xD;
&#xD;
          3. Existence of contraindications to MRI (cardiac or neural pacemaker, ferromagnetic&#xD;
             surgical clips, implants and metallic objects, foreign bodies intraocular, pregnancy,&#xD;
             claustrophobia).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marie-Laure Welter, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>GHPS, APHP, Paris, France</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marie-Laure Welter, MD, PhD</last_name>
    <email>marielaure.welter@icm-institute.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Carine Karachi, MD, PhD</last_name>
    <email>carine.karachi@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CIC-GHPS</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marie-Laure WELTER, PH</last_name>
      <phone>0142162461</phone>
      <email>marielaure.welter@icm-institute.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Groupe Hospitalier Pitie-Salpêtrière</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marie-Laure Welter, MD, PhD</last_name>
      <email>marie-laure.welter@psl.aphp.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>July 19, 2012</study_first_submitted>
  <study_first_submitted_qc>September 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2012</study_first_posted>
  <last_update_submitted>January 4, 2023</last_update_submitted>
  <last_update_submitted_qc>January 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>parkinson's disease</keyword>
  <keyword>subthalamic nucleus</keyword>
  <keyword>akinesia</keyword>
  <keyword>gait initiation</keyword>
  <keyword>neuronal activity</keyword>
  <keyword>before STN stimulation</keyword>
  <keyword>with STN stimulation</keyword>
  <keyword>functional MRI</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/NCT01682668
org study id: C11-40
secondary id: 2012-A00225-38
nct id: NCT01682668
lead sponsor: 
has dmc: No
This program aims to understand the role of the subthalamic nucleus in the control of the
      movement in healthy humans and patients with Parkinson's disease, how the STN dysfunction
      contributes to akinesia and how the STN stimulation improves motor signs in PD patients .
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Firing rate of the subthalamic neurons
time frame: During surgery for bilateral STN stimulation
description: Changes in the neuronal activity of the STN before, during and after the execution of an arm movement
measure: Evoked related potentials of the STN
time frame: 3-5 days after surgery for bilateral STN stimulation
description: Local-field potentials recordings with DBS electrodes when performing the execution of an arm movement or gait initiation
measure: Biomechanical parameters of gait initiation
time frame: 6 months
description: Gait initiation parameters by using a forceplate and EMG recordings
measure: BOLD signal during fMRI
time frame: 1 month before surgery
description: Changes in the BOLD signal during fMRI with virtual imagery of movement
measure: real-life assessment
time frame: 1 month after surgery
description: recording using the percept device
arm group label: Frequency of subthalamic stimulation
arm group type: Experimental
description: Comparison between healthy controls and PD patients (non-operable patients or who will be operated or already operated)
intervention type: Procedure
intervention name: Bilateral subthalamic stimulation
arm group label: Frequency of subthalamic stimulation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Marie-Laure Welter, MD, PhD
role: Principal Investigator
affiliation: GHPS, APHP, Paris, France
last name: Marie-Laure Welter, MD, PhD
email: marielaure.welter@icm-institute.org
last name: Carine Karachi, MD, PhD
email: carine.karachi@gmail.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Parkinson Disease