<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/NCT02205216</url>
  </required_header>
  <id_info>
    <org_study_id>VD226/14</org_study_id>
    <nct_id>NCT02205216</nct_id>
  </id_info>
  <brief_title>Can tDCS Enhance Efficacy of Rehabilitative Intervention for Freezing of Gait in Parkinson's Disease?</brief_title>
  <official_title>Can Transcranial Direct Stimulation Enhance the Efficacy of a Rehabilitative Intervention for the Treatment of Freezing of Gait in Parkinson's Disease? A Double Blind Randomized Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Vaudois</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire Vaudois</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Freezing of gait in Parkinson's disease (PD) is a major cause of disability and falls and&#xD;
      responds often incompletely to conventional therapy. The pathogenesis remains largely unknown&#xD;
      and therapeutic alternatives are needed. Rehabilitative interventions that consist of&#xD;
      learning cognitive strategies with sensory cueing to prevent and to overcome FOG represent&#xD;
      the most efficacious intervention, but difficulties in learning and execution of these&#xD;
      cognitive strategies are the main cause of failure. Transcranial direct current stimulation&#xD;
      (tDCS) enhances motor task learning and execution in patients with PD and might enhance the&#xD;
      efficacy of rehabilitative interventions.&#xD;
&#xD;
      This study intends to address the following question whether tDCS can enhance the efficacy of&#xD;
      rehabilitative interventions in the treatment of freezing of gait in Parkinson's disease?&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <primary_completion_date type="Anticipated">August 2017</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>Parallel Assignment</intervention_model>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Walking parcours</measure>
    <time_frame>from baseline to one month follow-up</time_frame>
    <description>This standardized parcours, performed under guidance of a physiotherapist, includes real-life conditions which are known to precipitate freezing. Time needed to perform the parcours and number of FOG episodes will be assessed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>New Freezing of Gait Questionnaire (N-FOGQ)</measure>
    <time_frame>from baseline to follow-up periods (immediately, 1 and 3 months after the last intervention)</time_frame>
    <description>NFOG-Q is a widely used and validated questionnaire for quantifying FOG severity and frequency in the daily living</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)</measure>
    <time_frame>from baseline to follow-up periods (immediately, 1 and 3 months after the last intervention)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>39-Item Parkinson's Disease Questionnaire (PDQ-39)</measure>
    <time_frame>from baseline to follow-up periods (immediately, 1 and 3 months after the last intervention)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beck Depression Inventory (BDI)</measure>
    <time_frame>from baseline to follow-up periods (immediately, 1 and 3 months after the last intervention)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>10 Meter Walk Test (10MWT)</measure>
    <time_frame>from baseline to follow-up periods (immediately, 1 and 3 months after the last intervention)</time_frame>
    <description>10MWT measures the time taken and the number of steps needed to walk a 10-meter distance from a standing position. Gait testing includes three averaged trials.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Timed Up &amp; GO (TUG)</measure>
    <time_frame>from baseline to follow-up periods (immediately, 1 and 3 months after the last intervention)</time_frame>
    <description>TUG requires patients to get up of a standard armed-chair, to walk 3 meters away, to turn around a cone, to walk back and to sit down.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>Active tDCS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Active tDCS combined with a rehabilitative intervention consisting of cognitive training and sensory cueing.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham tDCS</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham tDCS combined with a rehabilitative intervention consisting of cognitive training and sensory cueing.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Active tDCS</intervention_name>
    <description>anode over the motor and premotor cortex with cathodes placed over both mastoids. TDCS will be applied for 20 minutes at 2 mA.</description>
    <arm_group_label>Active tDCS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham tDCS</intervention_name>
    <description>anode and cathode placed 1 cm apart over the forehead and DC (1mA) applied for 1-2 min, short-circuited through the skin creating the same temporary &quot;tingling&quot; sensation without effects on the brain.</description>
    <arm_group_label>Sham tDCS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Rehabilitation Therapy</intervention_name>
    <description>All patients will undergo a rehabilitation therapy intervention (2x a week for 4 weeks = 8 intervention sessions) with simultaneous sham or active tDCS. The trained physiotherapist will follow a standardized program with checklist. Each of the 8 training session will last approximately 45min. The rehabilitative interventions include:&#xD;
cognitive training: attentional strategies (mental counting, mental obstacle)&#xD;
transfer training: everyday activities&#xD;
motor training (walking) with sensory cueing (visual, acoustic, cane, ball) The rehabilitation therapy is divided into two sessions both including a 5 minutes warm-up and the learning of cueing and movement strategies based on different modalities (cognitive, visual, tactile and auditory).</description>
    <arm_group_label>Active tDCS</arm_group_label>
    <arm_group_label>Sham tDCS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  men and women aged 30 to 80 years with DOPA-responsive PD Hoehn and Yahr (HY) grade of&#xD;
             2 to 4 while &quot;off&quot;&#xD;
&#xD;
          -  must be on a regimen including levodopa&#xD;
&#xD;
          -  total dose of levodopa and dopamine agonists (using dopamine equivalents) has to be&#xD;
             equal to or more than 300 milligrams per day&#xD;
&#xD;
          -  Gait difficulties with Freezing of Gait as defined by MDS-UPDRS I score ≥ 2 in FOG&#xD;
&#xD;
          -  Optimal conventional PD medication for &gt; 1 month prior to screening&#xD;
&#xD;
          -  scheduled for rehabilitative intervention for the treatment of freezing of gait&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  significant concurrent medical or psychiatric disease&#xD;
&#xD;
          -  history of seizures and epilepsy&#xD;
&#xD;
          -  Dementia or other neurodegenerative disease (besides PD)&#xD;
&#xD;
          -  pallidotomy, implanted electrodes and generator for deep brain stimulation&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  surgically or traumatically implanted foreign bodies such as an implanted medical&#xD;
             pump, implanted hearing aids, metal plate in the skull, or metal implant in the skull&#xD;
             or eyes (other than dental appliances or fillings) that may pose a physical hazard&#xD;
             during tDCS.&#xD;
&#xD;
          -  Study would cause undue risk or stress for reasons such as tendency to fall, excessive&#xD;
             fatigue, general frailty, or excessive apprehensiveness.&#xD;
&#xD;
          -  significant postural instability with daily falls, inability to walk the parcours or&#xD;
             inability to walk 10 meters.&#xD;
&#xD;
          -  presence of significant cognitive dysfunction as determined by Montreal Cognitive&#xD;
             Assessment (MOCA) &lt;20 or mentally impaired patients having no capacity to provide&#xD;
             their own consent (the physician establishing the diagnosis and applying UPDRS will&#xD;
             evaluate patient's mental capacity using conventional clinical interview).&#xD;
&#xD;
          -  presence of other co-morbid conditions that can contribute to gait dysfunction&#xD;
             (orthopedic, rheumatologic, cardiac, other)&#xD;
&#xD;
          -  presence of clinically significant hallucinations&#xD;
&#xD;
          -  participation in any rehabilitation therapy for FOG within the last six months prior&#xD;
             to screening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Benninger, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalier Universitaire Vaudois</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Vaudois</name>
      <address>
        <city>Lausanne</city>
        <state>Vaud</state>
        <zip>1011</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David Benninger, MD</last_name>
      <phone>+41 21 314 95 83</phone>
      <email>david.benninger@chuv.ch</email>
    </contact>
    <investigator>
      <last_name>David Benninger, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>July 30, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 31, 2014</study_first_posted>
  <last_update_submitted>July 3, 2015</last_update_submitted>
  <last_update_submitted_qc>July 3, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 7, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centre Hospitalier Universitaire Vaudois</investigator_affiliation>
    <investigator_full_name>David Benninger, MD</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>tDCS</keyword>
  <keyword>FOG</keyword>
  <keyword>Freezing of Gait</keyword>
  <keyword>Parkinson</keyword>
  <keyword>Rehabilitation</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/NCT02205216
org study id: VD226/14
nct id: NCT02205216
lead sponsor: 
has dmc: Yes
Freezing of gait in Parkinson's disease (PD) is a major cause of disability and falls and
      responds often incompletely to conventional therapy. The pathogenesis remains largely unknown
      and therapeutic alternatives are needed. Rehabilitative interventions that consist of
      learning cognitive strategies with sensory cueing to prevent and to overcome FOG represent
      the most efficacious intervention, but difficulties in learning and execution of these
      cognitive strategies are the main cause of failure. Transcranial direct current stimulation
      (tDCS) enhances motor task learning and execution in patients with PD and might enhance the
      efficacy of rehabilitative interventions.

      This study intends to address the following question whether tDCS can enhance the efficacy of
      rehabilitative interventions in the treatment of freezing of gait in Parkinson's disease?
allocation: Randomized
intervention model: Parallel Assignment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Walking parcours
time frame: from baseline to one month follow-up
description: This standardized parcours, performed under guidance of a physiotherapist, includes real-life conditions which are known to precipitate freezing. Time needed to perform the parcours and number of FOG episodes will be assessed.
measure: New Freezing of Gait Questionnaire (N-FOGQ)
time frame: from baseline to follow-up periods (immediately, 1 and 3 months after the last intervention)
description: NFOG-Q is a widely used and validated questionnaire for quantifying FOG severity and frequency in the daily living
measure: Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
time frame: from baseline to follow-up periods (immediately, 1 and 3 months after the last intervention)
measure: 39-Item Parkinson's Disease Questionnaire (PDQ-39)
time frame: from baseline to follow-up periods (immediately, 1 and 3 months after the last intervention)
measure: Beck Depression Inventory (BDI)
time frame: from baseline to follow-up periods (immediately, 1 and 3 months after the last intervention)
measure: 10 Meter Walk Test (10MWT)
time frame: from baseline to follow-up periods (immediately, 1 and 3 months after the last intervention)
description: 10MWT measures the time taken and the number of steps needed to walk a 10-meter distance from a standing position. Gait testing includes three averaged trials.
measure: Timed Up & GO (TUG)
time frame: from baseline to follow-up periods (immediately, 1 and 3 months after the last intervention)
description: TUG requires patients to get up of a standard armed-chair, to walk 3 meters away, to turn around a cone, to walk back and to sit down.
arm group label: Active tDCS
arm group type: Active Comparator
description: Active tDCS combined with a rehabilitative intervention consisting of cognitive training and sensory cueing.
arm group label: Sham tDCS
arm group type: Sham Comparator
description: Sham tDCS combined with a rehabilitative intervention consisting of cognitive training and sensory cueing.
intervention type: Device
intervention name: Active tDCS
description: anode over the motor and premotor cortex with cathodes placed over both mastoids. TDCS will be applied for 20 minutes at 2 mA.
arm group label: Active tDCS
intervention type: Device
intervention name: Sham tDCS
description: anode and cathode placed 1 cm apart over the forehead and DC (1mA) applied for 1-2 min, short-circuited through the skin creating the same temporary "tingling" sensation without effects on the brain.
arm group label: Sham tDCS
intervention type: Behavioral
intervention name: Rehabilitation Therapy
description: All patients will undergo a rehabilitation therapy intervention (2x a week for 4 weeks = 8 intervention sessions) with simultaneous sham or active tDCS. The trained physiotherapist will follow a standardized program with checklist. Each of the 8 training session will last approximately 45min. The rehabilitative interventions include:
cognitive training: attentional strategies (mental counting, mental obstacle)
transfer training: everyday activities
motor training (walking) with sensory cueing (visual, acoustic, cane, ball) The rehabilitation therapy is divided into two sessions both including a 5 minutes warm-up and the learning of cueing and movement strategies based on different modalities (cognitive, visual, tactile and auditory).
arm group label: Active tDCS
arm group label: Sham tDCS
criteria: 
gender: All
minimum age: 30 Years
maximum age: 80 Years
healthy volunteers: No
last name: David Benninger, MD
role: Principal Investigator
affiliation: Centre Hospitalier Universitaire Vaudois
facility: 
status: Recruiting
contact: 
investigator: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: Centre Hospitalier Universitaire Vaudois
investigator full name: David Benninger, MD
investigator title: MD
mesh term: Parkinson Disease