<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/NCT03780426</url>
  </required_header>
  <id_info>
    <org_study_id>Fundacion de Investigación HM</org_study_id>
    <nct_id>NCT03780426</nct_id>
  </id_info>
  <brief_title>tSMS in Essential Tremor</brief_title>
  <official_title>Transcranial Static Magnetic Field Stimulation (tSMS) in Essential Tremor</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundación de investigación HM</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fundación de investigación HM</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is randomized double-blind study to study the hypothesis that transcranial static&#xD;
      magnetic field stimulation of the primary motor cortex improves tremor in patients with&#xD;
      essential tremor. Half of the patients will receive tSMS of the left hemisphere and the other&#xD;
      half of the right hemisphere.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2018</start_date>
  <completion_date type="Actual">December 1, 2019</completion_date>
  <primary_completion_date type="Actual">December 1, 2019</primary_completion_date>
  <phase>Phase 2</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in postural tremor amplitude in the hand contralateral to hemispheren that received tSMS treatment compared to the hand contralateral to the hemisphere that received sham treatment, as measured by accelerometry.</measure>
    <time_frame>Immediately after treatment compared baseline</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in postural tremor amplitude 15 minutes after treatment, as measured by accelerometry.</measure>
    <time_frame>15 minutes after treatment compared to baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in rest tremor amplitude, as measured by accelerometry.</measure>
    <time_frame>Immediately after treatment and 15 minutes after treatment compared baseline.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in tremor frequency, as measured by accelerometry.</measure>
    <time_frame>Immediately after treatment and 15 minutes after treatment compared baseline.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in the Clinical Rating Scale for Tremor part B (drawing)</measure>
    <time_frame>5 minutes after treatment and 20 minutes after treatment compared to baseline</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Essential Tremor</condition>
  <arm_group>
    <arm_group_label>tSMS left motor cortex (sham right)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>30 min of tSMS applied to the left motor cortex with sham on the right motor cortex</description>
  </arm_group>
  <arm_group>
    <arm_group_label>tSMS right motor cortex (sham left)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>30 min of tSMS applied to the right motor cortex with sham on the left motor cortex</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>tSMS</intervention_name>
    <description>Transcranial static magnetic field stimulation (tSMS) is a non-invasive brain stimulation (NIBS) technique that decreases cortical excitability (Oliviero et al., 2011; Oliviero et al., 2015; Dileone et al., 2018). Static magnetic fields suitable for tSMS are obtained with commercially available neodymium magnets. We will use a cylindrical neodymium magnet of 45 mm diameter and 30 mm of thickness, with a weight of 360 g (MAG45r; Neurek SL, Toledo, Spain), which will be applied with south polarity to the left or right motor cortex, using a tSMS helmet (MAGmv1.0; Neurek SL, Toledo, Spain).</description>
    <arm_group_label>tSMS left motor cortex (sham right)</arm_group_label>
    <arm_group_label>tSMS right motor cortex (sham left)</arm_group_label>
    <other_name>MAGmv1.0 with MAG45r, Neurek S.L. (Toledo, Spain)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>sham</intervention_name>
    <description>A non-magnetic metal cylinder, with the same size, weight and appearance of the magnet, will be used for sham stimulation (MAG45s; Neurek SL, Toledo, Spain) of motor cortex contralateral to the stimulated hemisphere.</description>
    <arm_group_label>tSMS left motor cortex (sham right)</arm_group_label>
    <arm_group_label>tSMS right motor cortex (sham left)</arm_group_label>
    <other_name>MAGmv1.0 with MAG45s, Neurek S.L. (Toledo, Spain)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Essential tremor&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  MRI-incompatible metal objects in the body (e.g. cardiac pacemakers)&#xD;
&#xD;
          -  other main neuropsychiatric co-morbidity&#xD;
&#xD;
          -  pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CINAC, Hospital Universitario Puerta del Sur</name>
      <address>
        <city>Móstoles</city>
        <state>Madrid</state>
        <zip>28938</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Oliviero A, Mordillo-Mateos L, Arias P, Panyavin I, Foffani G, Aguilar J. Transcranial static magnetic field stimulation of the human motor cortex. J Physiol. 2011 Oct 15;589(Pt 20):4949-58. doi: 10.1113/jphysiol.2011.211953. Epub 2011 Aug 1.</citation>
    <PMID>21807616</PMID>
  </reference>
  <reference>
    <citation>Oliviero A, Carrasco-Lopez MC, Campolo M, Perez-Borrego YA, Soto-Leon V, Gonzalez-Rosa JJ, Higuero AM, Strange BA, Abad-Rodriguez J, Foffani G. Safety Study of Transcranial Static Magnetic Field Stimulation (tSMS) of the Human Cortex. Brain Stimul. 2015 May-Jun;8(3):481-5. doi: 10.1016/j.brs.2014.12.002. Epub 2014 Dec 11.</citation>
    <PMID>25595064</PMID>
  </reference>
  <reference>
    <citation>Dileone M, Mordillo-Mateos L, Oliviero A, Foffani G. Long-lasting effects of transcranial static magnetic field stimulation on motor cortex excitability. Brain Stimul. 2018 Jul-Aug;11(4):676-688. doi: 10.1016/j.brs.2018.02.005. Epub 2018 Feb 7.</citation>
    <PMID>29500043</PMID>
  </reference>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>June 3, 2022</last_update_submitted>
  <last_update_submitted_qc>June 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tremor</mesh_term>
    <mesh_term>Essential Tremor</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/NCT03780426
org study id: Fundacion de Investigación HM
nct id: NCT03780426
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This is randomized double-blind study to study the hypothesis that transcranial static
      magnetic field stimulation of the primary motor cortex improves tremor in patients with
      essential tremor. Half of the patients will receive tSMS of the left hemisphere and the other
      half of the right hemisphere.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change from baseline in postural tremor amplitude in the hand contralateral to hemispheren that received tSMS treatment compared to the hand contralateral to the hemisphere that received sham treatment, as measured by accelerometry.
time frame: Immediately after treatment compared baseline
measure: Change from baseline in postural tremor amplitude 15 minutes after treatment, as measured by accelerometry.
time frame: 15 minutes after treatment compared to baseline
measure: Change from baseline in rest tremor amplitude, as measured by accelerometry.
time frame: Immediately after treatment and 15 minutes after treatment compared baseline.
measure: Change from baseline in tremor frequency, as measured by accelerometry.
time frame: Immediately after treatment and 15 minutes after treatment compared baseline.
measure: Change from baseline in the Clinical Rating Scale for Tremor part B (drawing)
time frame: 5 minutes after treatment and 20 minutes after treatment compared to baseline
arm group label: tSMS left motor cortex (sham right)
arm group type: Experimental
description: 30 min of tSMS applied to the left motor cortex with sham on the right motor cortex
arm group label: tSMS right motor cortex (sham left)
arm group type: Experimental
description: 30 min of tSMS applied to the right motor cortex with sham on the left motor cortex
intervention type: Device
intervention name: tSMS
description: Transcranial static magnetic field stimulation (tSMS) is a non-invasive brain stimulation (NIBS) technique that decreases cortical excitability (Oliviero et al., 2011; Oliviero et al., 2015; Dileone et al., 2018). Static magnetic fields suitable for tSMS are obtained with commercially available neodymium magnets. We will use a cylindrical neodymium magnet of 45 mm diameter and 30 mm of thickness, with a weight of 360 g (MAG45r; Neurek SL, Toledo, Spain), which will be applied with south polarity to the left or right motor cortex, using a tSMS helmet (MAGmv1.0; Neurek SL, Toledo, Spain).
arm group label: tSMS left motor cortex (sham right)
arm group label: tSMS right motor cortex (sham left)
other name: MAGmv1.0 with MAG45r, Neurek S.L. (Toledo, Spain)
intervention type: Device
intervention name: sham
description: A non-magnetic metal cylinder, with the same size, weight and appearance of the magnet, will be used for sham stimulation (MAG45s; Neurek SL, Toledo, Spain) of motor cortex contralateral to the stimulated hemisphere.
arm group label: tSMS left motor cortex (sham right)
arm group label: tSMS right motor cortex (sham left)
other name: MAGmv1.0 with MAG45s, Neurek S.L. (Toledo, Spain)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Spain
citation: Oliviero A, Mordillo-Mateos L, Arias P, Panyavin I, Foffani G, Aguilar J. Transcranial static magnetic field stimulation of the human motor cortex. J Physiol. 2011 Oct 15;589(Pt 20):4949-58. doi: 10.1113/jphysiol.2011.211953. Epub 2011 Aug 1.
PMID: 21807616
citation: Oliviero A, Carrasco-Lopez MC, Campolo M, Perez-Borrego YA, Soto-Leon V, Gonzalez-Rosa JJ, Higuero AM, Strange BA, Abad-Rodriguez J, Foffani G. Safety Study of Transcranial Static Magnetic Field Stimulation (tSMS) of the Human Cortex. Brain Stimul. 2015 May-Jun;8(3):481-5. doi: 10.1016/j.brs.2014.12.002. Epub 2014 Dec 11.
PMID: 25595064
citation: Dileone M, Mordillo-Mateos L, Oliviero A, Foffani G. Long-lasting effects of transcranial static magnetic field stimulation on motor cortex excitability. Brain Stimul. 2018 Jul-Aug;11(4):676-688. doi: 10.1016/j.brs.2018.02.005. Epub 2018 Feb 7.
PMID: 29500043
responsible party type: Sponsor
mesh term: Tremor
mesh term: Essential Tremor