<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/NCT02976298</url>
  </required_header>
  <id_info>
    <org_study_id>C12-05</org_study_id>
    <secondary_id>2012-A00796-37</secondary_id>
    <nct_id>NCT02976298</nct_id>
  </id_info>
  <brief_title>Effects of Cerebellum or Supplementary Motor Area Functional Inactivation on Gait and Balance Control</brief_title>
  <acronym>CERESMARCHE</acronym>
  <official_title>Rôle du Cervelet et de l'Aire Motrice supplémentaire Dans le contrôle Postural au Cours de la Marche Chez l'Homme</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>
      In human, the physiology of gait and balance is not clearly established. By using functional&#xD;
      imaging and electrophysiological techniques, various brain regions from the cortex to the&#xD;
      midbrain area, including the cerebellum, have been identified as involved in such control.&#xD;
      The specific role of these structures in both the capacity to go forward (locomotion) and&#xD;
      stand upright (balance), but also in the different phases of the gait initiation process, are&#xD;
      not known, however. In this study,the investigators aimed to assess the specific role of both&#xD;
      the supplementary motor area (SMA) and the cerebellum in postural control during the&#xD;
      initiation of gait. For this purpose, the investigators plan to study the gait initiation in&#xD;
      20 healthy subjects before and after functional inactivation (using inhibitory repetitive&#xD;
      transcranial magnetic stimulation, rTMS) of the cerebellum or SMA. Biomechanical, kinematic&#xD;
      and electromyographic parameters of the gait initiation will be recorded using a force&#xD;
      platform, reflective markers with infrared cameras (VICON system) and lower limbs surface EMG&#xD;
      electrodes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2013</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Basic Science</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>postural control during gait initiation</measure>
    <time_frame>change between baseline and 5 minutes after transcranial magnetic stimulation</time_frame>
    <description>braking capacity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>duration of anticipatory postural adjustments</measure>
    <time_frame>change between baseline and 5 minutes after transcranial magnetic stimulation</time_frame>
    <description>duration</description>
  </secondary_outcome>
  <other_outcome>
    <measure>centre of foot pressure displacement during postural adjustments</measure>
    <time_frame>change between baseline and 5 minutes after transcranial magnetic stimulation</time_frame>
    <description>centre of foot pressure displacement measured by force platform</description>
  </other_outcome>
  <other_outcome>
    <measure>step length</measure>
    <time_frame>change between baseline and 5 minutes after transcranial magnetic stimulation</time_frame>
    <description>step length</description>
  </other_outcome>
  <other_outcome>
    <measure>step velocity</measure>
    <time_frame>change between baseline and 5 minutes after transcranial magnetic stimulation</time_frame>
    <description>step velocity</description>
  </other_outcome>
  <other_outcome>
    <measure>duration of electromyographic activity of the tibialis anterior muscles</measure>
    <time_frame>change between baseline and 5 minutes after magnetic transcranial stimulation</time_frame>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Transcranial Magnetic Stimulation</condition>
  <arm_group>
    <arm_group_label>transcranial magnetic stimulation</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>sham transcranial magnetic stimulation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>supplementary motor area stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>supplementary motor area transcranial magnetic stimulation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>cerebellar stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>cerebellar transcranial magnetic stimulation</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>transcranial magnetic stimulation</intervention_name>
    <description>comparison of different conditions of transcranial magnetic stimulation</description>
    <arm_group_label>cerebellar stimulation</arm_group_label>
    <arm_group_label>supplementary motor area stimulation</arm_group_label>
    <arm_group_label>transcranial magnetic stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-70 years&#xD;
&#xD;
          -  agree to participate to the study with signature of the informed consent&#xD;
&#xD;
          -  heathy insurance&#xD;
&#xD;
          -  normal clinical exam&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous medical history of neurological, rheumatological, orthopedic or psychiatric&#xD;
             disorders&#xD;
&#xD;
          -  contra-indication to MRI or TMS&#xD;
&#xD;
          -  drug treatment that modifies the nervous central system excitability (antidepressant,&#xD;
             antiepileptic, neuroleptic)&#xD;
&#xD;
          -  chronic alcoholism&#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>APHP</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sabine Meunier, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Institut National de la Santé Et de la Recherche Médicale, France</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>M.L.Welter</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>March 26, 2013</study_first_submitted>
  <study_first_submitted_qc>November 24, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>December 6, 2016</last_update_submitted>
  <last_update_submitted_qc>December 6, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 7, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cerebellum</keyword>
  <keyword>supplementary motor area</keyword>
  <!-- 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/NCT02976298
org study id: C12-05
secondary id: 2012-A00796-37
nct id: NCT02976298
lead sponsor: 
has dmc: No
In human, the physiology of gait and balance is not clearly established. By using functional
      imaging and electrophysiological techniques, various brain regions from the cortex to the
      midbrain area, including the cerebellum, have been identified as involved in such control.
      The specific role of these structures in both the capacity to go forward (locomotion) and
      stand upright (balance), but also in the different phases of the gait initiation process, are
      not known, however. In this study,the investigators aimed to assess the specific role of both
      the supplementary motor area (SMA) and the cerebellum in postural control during the
      initiation of gait. For this purpose, the investigators plan to study the gait initiation in
      20 healthy subjects before and after functional inactivation (using inhibitory repetitive
      transcranial magnetic stimulation, rTMS) of the cerebellum or SMA. Biomechanical, kinematic
      and electromyographic parameters of the gait initiation will be recorded using a force
      platform, reflective markers with infrared cameras (VICON system) and lower limbs surface EMG
      electrodes.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Double (Participant, Outcomes Assessor)
measure: postural control during gait initiation
time frame: change between baseline and 5 minutes after transcranial magnetic stimulation
description: braking capacity
measure: duration of anticipatory postural adjustments
time frame: change between baseline and 5 minutes after transcranial magnetic stimulation
description: duration
measure: centre of foot pressure displacement during postural adjustments
time frame: change between baseline and 5 minutes after transcranial magnetic stimulation
description: centre of foot pressure displacement measured by force platform
measure: step length
time frame: change between baseline and 5 minutes after transcranial magnetic stimulation
description: step length
measure: step velocity
time frame: change between baseline and 5 minutes after transcranial magnetic stimulation
description: step velocity
measure: duration of electromyographic activity of the tibialis anterior muscles
time frame: change between baseline and 5 minutes after magnetic transcranial stimulation
arm group label: transcranial magnetic stimulation
arm group type: Sham Comparator
description: sham transcranial magnetic stimulation
arm group label: supplementary motor area stimulation
arm group type: Experimental
description: supplementary motor area transcranial magnetic stimulation
arm group label: cerebellar stimulation
arm group type: Experimental
description: cerebellar transcranial magnetic stimulation
intervention type: Other
intervention name: transcranial magnetic stimulation
description: comparison of different conditions of transcranial magnetic stimulation
arm group label: cerebellar stimulation
arm group label: supplementary motor area stimulation
arm group label: transcranial magnetic 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: APHP
last name: Sabine Meunier, MD, PhD
role: Study Director
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
facility: 
country: France
responsible party type: Sponsor