<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/NCT04432363</url>
  </required_header>
  <id_info>
    <org_study_id>30012020204820</org_study_id>
    <nct_id>NCT04432363</nct_id>
  </id_info>
  <brief_title>Effects of tDCS in M1 and DLPFC on Pain Processing in Healthy Volunteers</brief_title>
  <official_title>Effects of Transcranial Direct Current Stimulation on Primary Cortex and Prefrontal Dorsolateral Cortex in Pain Processing on Healthy Volunteers: A Triple Blind Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Rey Juan Carlos</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad Rey Juan Carlos</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the effects of a direct current applied transcranial&#xD;
      over two cortical areas on healthy volunteers' pain processing.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 6, 2020</start_date>
  <completion_date type="Actual">July 25, 2020</completion_date>
  <primary_completion_date type="Actual">July 25, 2020</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>
    <intervention_model_description>Three groups cross over study with two intervention groups and one sham group.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Conditioned Pain Modulation</measure>
    <time_frame>Pre-intervention and immediately after treatment</time_frame>
    <description>Pain pressure threshold change after a painful ischemic stimulus</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain pressure algometer temporal summation</measure>
    <time_frame>Pre-intervention and immediately after treatment</time_frame>
    <description>Change in pain perceived between the first and tenth painful pressure stimulus</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain pressure threshold</measure>
    <time_frame>Pre-intervention and immediately after treatment</time_frame>
    <description>Measurement of pressure applied until the perception of pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain pressure tolerance</measure>
    <time_frame>Pre-intervention and immediately after treatment</time_frame>
    <description>Measurement of maximal painful pressure tolerate using a pressure algometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neural mechanosensitivity</measure>
    <time_frame>Pre-intervention and immediately after treatment</time_frame>
    <description>Measurement of range of motion achieved until the perception of tension</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cold hyperalgesia with a cold pack</measure>
    <time_frame>Pre-intervention and immediately after treatment</time_frame>
    <description>Pain rated in a visual analogue scale after 10 seconds of a cold stimulus</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Isometric grip strength</measure>
    <time_frame>Pre-intervention and immediately after treatment</time_frame>
    <description>Maximal pressure achieved in a isometric gripping task</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Pain Processing in Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>M1 stimulation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A 20 minutes 1mA direct current stimulation over left M1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>M1+DLPFC stimulation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A 20 minutes 1mA direct current stimulation over left M1 and 1mA direct current stimulation over left DLPFC.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham stimulation</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>A 20 minutes sham stimulation where the device only is working first 30s and last 30s of the intervention and have a 10 seconds fade out in intensity at each ramp.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Transcranial direct current stimulation</intervention_name>
    <description>Direct current application over the scalp to stimulate and change the excitability of the cortical areas underneath the electrodes (in this case left primary motor cortex and left dorsolateral prefrontal cortex).</description>
    <arm_group_label>M1 stimulation</arm_group_label>
    <arm_group_label>M1+DLPFC stimulation</arm_group_label>
    <arm_group_label>Sham stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 18 and 40 years&#xD;
&#xD;
          -  Comprehension of the study tasks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of pain in the previous 6 months&#xD;
&#xD;
          -  Altered sensitivity in the tested regions&#xD;
&#xD;
          -  Intolerance to electrotherapy&#xD;
&#xD;
          -  Presence of pacemakers or any other implanted device&#xD;
&#xD;
          -  Ulcers or scars in the skin at the location of the electrodes&#xD;
&#xD;
          -  Treatment with direct current stimulation within one week&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Frequent headaches&#xD;
&#xD;
          -  Epilepsy&#xD;
&#xD;
          -  History of neuromuscular disease&#xD;
&#xD;
          -  Previous clinical history of cervical surgery&#xD;
&#xD;
          -  Injuries or surgery affecting the upper limb&#xD;
&#xD;
          -  diabetes mellitus&#xD;
&#xD;
          -  Cardiovascular diseases&#xD;
&#xD;
          -  Oncological diseases&#xD;
&#xD;
          -  Consumption of analgesic drugs 7 days before the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Josue Fernandez Carnero, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Universidad Rey Juan Carlos</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universidad Rey Juan Carlos</name>
      <address>
        <city>Alcorcon</city>
        <state>Madrid</state>
        <zip>28922</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <link>
    <url>http://www.urjc.es</url>
    <description>Rey Juan Carlos University</description>
  </link>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>October 28, 2020</last_update_submitted>
  <last_update_submitted_qc>October 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad Rey Juan Carlos</investigator_affiliation>
    <investigator_full_name>Josue Fernandez Carnero</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <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/NCT04432363
org study id: 30012020204820
nct id: NCT04432363
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The purpose of this study is to evaluate the effects of a direct current applied transcranial
      over two cortical areas on healthy volunteers' pain processing.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Three groups cross over study with two intervention groups and one sham group.
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Conditioned Pain Modulation
time frame: Pre-intervention and immediately after treatment
description: Pain pressure threshold change after a painful ischemic stimulus
measure: Pain pressure algometer temporal summation
time frame: Pre-intervention and immediately after treatment
description: Change in pain perceived between the first and tenth painful pressure stimulus
measure: Pain pressure threshold
time frame: Pre-intervention and immediately after treatment
description: Measurement of pressure applied until the perception of pain
measure: Pain pressure tolerance
time frame: Pre-intervention and immediately after treatment
description: Measurement of maximal painful pressure tolerate using a pressure algometer
measure: Neural mechanosensitivity
time frame: Pre-intervention and immediately after treatment
description: Measurement of range of motion achieved until the perception of tension
measure: Cold hyperalgesia with a cold pack
time frame: Pre-intervention and immediately after treatment
description: Pain rated in a visual analogue scale after 10 seconds of a cold stimulus
measure: Isometric grip strength
time frame: Pre-intervention and immediately after treatment
description: Maximal pressure achieved in a isometric gripping task
arm group label: M1 stimulation
arm group type: Active Comparator
description: A 20 minutes 1mA direct current stimulation over left M1.
arm group label: M1+DLPFC stimulation
arm group type: Active Comparator
description: A 20 minutes 1mA direct current stimulation over left M1 and 1mA direct current stimulation over left DLPFC.
arm group label: Sham stimulation
arm group type: Sham Comparator
description: A 20 minutes sham stimulation where the device only is working first 30s and last 30s of the intervention and have a 10 seconds fade out in intensity at each ramp.
intervention type: Device
intervention name: Transcranial direct current stimulation
description: Direct current application over the scalp to stimulate and change the excitability of the cortical areas underneath the electrodes (in this case left primary motor cortex and left dorsolateral prefrontal cortex).
arm group label: M1 stimulation
arm group label: M1+DLPFC stimulation
arm group label: Sham stimulation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Josue Fernandez Carnero, PhD
role: Study Director
affiliation: Universidad Rey Juan Carlos
facility: 
country: Spain
url: http://www.urjc.es
description: Rey Juan Carlos University
responsible party type: Principal Investigator
investigator affiliation: Universidad Rey Juan Carlos
investigator full name: Josue Fernandez Carnero
investigator title: Associate Professor
sharing ipd: No