<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/NCT02978924</url>
  </required_header>
  <id_info>
    <org_study_id>C16-26</org_study_id>
    <secondary_id>2016-A01202-49</secondary_id>
    <nct_id>NCT02978924</nct_id>
  </id_info>
  <brief_title>Trans-spinal Direct Current Stimulation in Primary Orthostatic Tremor</brief_title>
  <acronym>STOP</acronym>
  <official_title>Trans-spinal Direct Current Stimulation in Primary Orthostatic Tremor</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To explore the effect of cathodal tsDCS vs sham tsDCS in primary orthostatic tremor. The&#xD;
      investigators hypothesize that cathodal tsDCS but not sham tsDCS would be able to restore&#xD;
      both motor and sensory pathways of the spinal cord leading to functional improvements.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Regain of function and improvement of motor skills is a major challenge in motor disorders in&#xD;
      which spinal cord functions play a key role. The growing development of non-invasive brain&#xD;
      stimulations in the past decade led to significant progress in the understanding of neuronal&#xD;
      abnormalities in patients with movement disorders that opens up new vistas for experimental&#xD;
      treatments. However, these treatments are currently limited due to their high cost and lack&#xD;
      of possibility to use in outpatients. Recently, trans-spinal direct current stimulation&#xD;
      (tsDCS) has emerged as a novel tool to modulate non-invasively spinal cord excitability. This&#xD;
      may be an excellent alternative to epidural stimulation, the sole technique available up to&#xD;
      now to alter spinal functions in an invasive fashion. The overall goal of this study is to&#xD;
      assess the potential of tsDCS to restore spinal cord functions in patients with primary&#xD;
      orthostatic tremor (POT), a disorder with little or no current therapeutic resources and high&#xD;
      disability for patients.&#xD;
&#xD;
      Using a crossover, randomized, double-blinded approach, cathodal (2mA, 20 min) or sham tsDCS&#xD;
      (with the active electrodes over the thoracic level and the reference electrode on the right&#xD;
      shoulder) will be delivered to 15 patients with POT. The maximal time in upright position&#xD;
      determined by a force platform, the cortical excitability assessed by transcranial magnetic&#xD;
      stimulation (input / output curve of the tibialis anterior muscle and short-latency afferent&#xD;
      inhibition) and EMG activities of lower extremity muscles will be measured before (PRE),&#xD;
      immediately and 30 minutes after current offset (POST0 and POST30 respectively). Cathodal and&#xD;
      sham tsDCS will be delivered in two different sessions with a washout period of at least 7&#xD;
      days. The investigators anticipate that cathodal tsDCS but not sham tsDCS will be able to&#xD;
      modulate both sensory and motor functions in POT and will, in turn, lead to functional&#xD;
      improvement.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 17, 2017</start_date>
  <completion_date type="Actual">November 28, 2017</completion_date>
  <primary_completion_date type="Actual">November 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>Crossover Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in maximal time in the upright position without support</measure>
    <time_frame>Before (PRE) and immediately after current offset (POST0)</time_frame>
    <description>Force plateform</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quantitative assessment of tremor (EMG)</measure>
    <time_frame>Before (PRE), immediately after (POST0) and 30min (POST30) current offset</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cortical excitability assessed by Transcranial Magnetic Stimulation</measure>
    <time_frame>Before (PRE), immediately after (POST0) and 30min (POST30) current offset</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Primary Orthostatic Tremor</condition>
  <arm_group>
    <arm_group_label>Cathodal tsDCS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>20 min of active treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham tsDCS</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>20 min of sham treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>tsDCS</intervention_name>
    <description>20 min of treatment applied at the thoracic level (active electrode) with reference placed on the right shoulder</description>
    <arm_group_label>Cathodal tsDCS</arm_group_label>
    <arm_group_label>Sham tsDCS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with POT diagnosed since at least 1 year&#xD;
&#xD;
          -  Normal neurological examination with the exception of POT&#xD;
&#xD;
          -  Patients with or without treatment for TOP, or with treatment not sufficiently&#xD;
             effective&#xD;
&#xD;
          -  Affiliated with the French social security scheme, universal medical coverages (CMU),&#xD;
             or an equivalent scheme&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Psychiatric or neurological conditions (with the exception of POT)&#xD;
&#xD;
          -  Presence of potential tsDCS risk factors including an electrically, magnetically or&#xD;
             mechanically activated implant (including cardiac pacemaker, epidural stimulation&#xD;
             electrodes, etc.), an intravascular clip or any other electrically sensitive support&#xD;
             system, damaged skin at the stimulation sites (i.e., skin with ingrown hairs, acne,&#xD;
             razor nicks, wounds that have not healed, recent scar tissue, broken skin, etc.)&#xD;
&#xD;
          -  Presence of TMS risk factor including cardiac pacemaker, history of epilepsy,&#xD;
             traumatic brain injury with loss of consciousness, intracerebral clips, cochlear or&#xD;
             ocular implants&#xD;
&#xD;
          -  Pregnancy in women (as determined by a urine pregnancy test in pre-menopausal women),&#xD;
             or lactating women or women planning pregnancy during the course of the study&#xD;
&#xD;
          -  Patients enrolled in another biomedical research at the time of the study&#xD;
&#xD;
          -  Participant who does not wish to be informed of any clinically relevant abnormalities&#xD;
             (as determined by the investigators) identified during the course of the study&#xD;
&#xD;
          -  Patient under guardianship or curatorship, or under judicial supervision&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marie Vidailhet, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>marie.vidailhet@psl.aphp.fr</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre investigation clinique</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <last_update_submitted>August 24, 2021</last_update_submitted>
  <last_update_submitted_qc>August 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>spinal cord</keyword>
  <keyword>tsDCS</keyword>
  <keyword>3D motion capture</keyword>
  <keyword>EMG</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tremor</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/NCT02978924
org study id: C16-26
secondary id: 2016-A01202-49
nct id: NCT02978924
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To explore the effect of cathodal tsDCS vs sham tsDCS in primary orthostatic tremor. The
      investigators hypothesize that cathodal tsDCS but not sham tsDCS would be able to restore
      both motor and sensory pathways of the spinal cord leading to functional improvements.
Regain of function and improvement of motor skills is a major challenge in motor disorders in
      which spinal cord functions play a key role. The growing development of non-invasive brain
      stimulations in the past decade led to significant progress in the understanding of neuronal
      abnormalities in patients with movement disorders that opens up new vistas for experimental
      treatments. However, these treatments are currently limited due to their high cost and lack
      of possibility to use in outpatients. Recently, trans-spinal direct current stimulation
      (tsDCS) has emerged as a novel tool to modulate non-invasively spinal cord excitability. This
      may be an excellent alternative to epidural stimulation, the sole technique available up to
      now to alter spinal functions in an invasive fashion. The overall goal of this study is to
      assess the potential of tsDCS to restore spinal cord functions in patients with primary
      orthostatic tremor (POT), a disorder with little or no current therapeutic resources and high
      disability for patients.

      Using a crossover, randomized, double-blinded approach, cathodal (2mA, 20 min) or sham tsDCS
      (with the active electrodes over the thoracic level and the reference electrode on the right
      shoulder) will be delivered to 15 patients with POT. The maximal time in upright position
      determined by a force platform, the cortical excitability assessed by transcranial magnetic
      stimulation (input / output curve of the tibialis anterior muscle and short-latency afferent
      inhibition) and EMG activities of lower extremity muscles will be measured before (PRE),
      immediately and 30 minutes after current offset (POST0 and POST30 respectively). Cathodal and
      sham tsDCS will be delivered in two different sessions with a washout period of at least 7
      days. The investigators anticipate that cathodal tsDCS but not sham tsDCS will be able to
      modulate both sensory and motor functions in POT and will, in turn, lead to functional
      improvement.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: Double (Participant, Outcomes Assessor)
measure: Change in maximal time in the upright position without support
time frame: Before (PRE) and immediately after current offset (POST0)
description: Force plateform
measure: Quantitative assessment of tremor (EMG)
time frame: Before (PRE), immediately after (POST0) and 30min (POST30) current offset
measure: Cortical excitability assessed by Transcranial Magnetic Stimulation
time frame: Before (PRE), immediately after (POST0) and 30min (POST30) current offset
arm group label: Cathodal tsDCS
arm group type: Active Comparator
description: 20 min of active treatment
arm group label: Sham tsDCS
arm group type: Sham Comparator
description: 20 min of sham treatment
intervention type: Device
intervention name: tsDCS
description: 20 min of treatment applied at the thoracic level (active electrode) with reference placed on the right shoulder
arm group label: Cathodal tsDCS
arm group label: Sham tsDCS
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Marie Vidailhet, MD
role: Principal Investigator
affiliation: marie.vidailhet@psl.aphp.fr
facility: 
country: France
responsible party type: Sponsor
mesh term: Tremor
sharing ipd: No