<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/NCT03263884</url>
  </required_header>
  <id_info>
    <org_study_id>N-20170041</org_study_id>
    <nct_id>NCT03263884</nct_id>
  </id_info>
  <brief_title>Repetitive Transcranial Magnetic Stimulation and the Development of Ongoing Muscle Pain</brief_title>
  <official_title>Repetitive Transcranial Magnetic Stimulation and the Development of Ongoing Muscle Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aalborg University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aalborg University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The main purpose of the study is to assess the mechanisms of repeated sessions of repetitive&#xD;
      trancranial magnetic stimulation (rTMS) applied on left dorsolateral prefrontal cortex on the&#xD;
      development of pain in a prolonged muscle pain model.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aims to investigate whether i) rTMS of left DLPFC will reduce the severity and&#xD;
      duration of experimentally induced muscle pain when a 5-day course of treatment is given&#xD;
      immediately following an initial nerve growth factor (NGF) injection; ii) the analgesic&#xD;
      effects of left DLPFC rTMS will be related to an improved cognitive network function as&#xD;
      assessed by electroencephalography (EEG).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">February 28, 2018</completion_date>
  <primary_completion_date type="Actual">November 30, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain relief</measure>
    <time_frame>Change from baseline at 2 weeks</time_frame>
    <description>Pain on an 11-point numerical rating scale (0 = no pain, 10 = most intense pain imaginable)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Muscle soreness</measure>
    <time_frame>Change from baseline at 2 weeks</time_frame>
    <description>7-point Likert scale; 0 = 'a complete absence of soreness', 1 = 'a light soreness in the muscle felt only when touched/vague ache', 2 = 'a moderate soreness felt only when touched/a slight persistent ache', '3 = 'a light muscle soreness when lifting or carrying objects', 4 = 'a light muscle soreness, stiffness or weakness when moving the wrist without gripping an object', 5 = 'a moderate muscle soreness, stiffness or weakness when moving the wrist', 6 = 'a severe muscle soreness, stiffness or weakness that limits the ability to move'</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-rated Tennis Elbow Evaluation</measure>
    <time_frame>Change from baseline at 2 weeks</time_frame>
    <description>The Patient-rated Tennis Elbow Evaluation will be used to assess average pain and disability of the injected arm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Attention network test</measure>
    <time_frame>Change from baseline at 2 weeks</time_frame>
    <description>This task assesses cognitive function in 3 domains: alerting, orienting, and executive function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pressure pain thresholds</measure>
    <time_frame>Change from baseline at 2 weeks</time_frame>
    <description>Pressure applied to the surface of the skin using a handheld algometer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cuff pressure algometry</measure>
    <time_frame>Change from baseline at 2 weeks</time_frame>
    <description>The experimental setup consists of a tourniquet cuff, a computer-controlled air compressor and an electronic visual analog scale VAS (Aalborg University, Denmark). The cuff is connected to the compressor and wrapped around the leg. The pain intensity is recorded with the electronic VAS and sampled at 10 Hz. The &quot;0 cm&quot; and &quot;10 cm&quot; extremes on the VAS are defined as &quot;no pain&quot; and as &quot;maximal pain&quot;, respectively. The compression rate of the cuff is programmed on and controlled by a computer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EEG recordings</measure>
    <time_frame>Change from baseline at 1 weeks</time_frame>
    <description>we will record brain activity in the following conditions: eyes closed rest, performance of a computer-based cognitive task (ANT).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Pain Relief</condition>
  <arm_group>
    <arm_group_label>Real treatment group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Transcranial magnetic stimulation (TMS) is used to stimulate small regions of the brain. During a TMS procedure, a magnetic field generator, or &quot;coil&quot;, is placed near the head of the person receiving the treatment. The coil produces small electric currents in the region of the brain just under the coil via electromagnetic induction.&#xD;
The protocol used in this research includes 20 minutes of 10Hz stimulation, 5 seconds on, 10 seconds off, at 110% RMT, for a total of 4000 pulses.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham treatment group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham coil is used to mimic the clicking sound of the TMS coil and skin stimulation</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Repetitive trancranial magnetic stimulation (rTMS) group</intervention_name>
    <description>Repetitive trancranial magnetic stimulation is applied on the dorsolateral prefrontal cortex. The protocol consists on 20 minutes of 10Hz stimulation, 5 seconds on, 10 seconds off, at 110% RMT, for a total of 4000 pulses.</description>
    <arm_group_label>Real treatment group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham group</intervention_name>
    <description>A sham coil is used to mimic the clicking sound of the trancranial magnetic coil and skin stimulation.</description>
    <arm_group_label>Sham treatment group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy men and women&#xD;
&#xD;
          -  Speak and understand English.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Drug addiction defined as the use of cannabis, opioids or other drugs&#xD;
&#xD;
          -  Previous neurologic, musculoskeletal or mental illnesses&#xD;
&#xD;
          -  Lack of ability to cooperate&#xD;
&#xD;
          -  History of chronic pain or current acute pain&#xD;
&#xD;
          -  Previous experience with rTMS&#xD;
&#xD;
          -  Contraindications to rTMS application (history of epilepsy, metal in the head or jaw&#xD;
             etc.).&#xD;
&#xD;
          -  Failure to pass the &quot;TASS questionnaire&quot; (TASS = Transcranial Magnetic Stimulation&#xD;
             Adult Safety Screen)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Enrico De Martino, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aalborg University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aalborg University</name>
      <address>
        <city>Aalborg</city>
        <state>Nordjylland</state>
        <zip>9000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</study_first_posted>
  <last_update_submitted>March 2, 2018</last_update_submitted>
  <last_update_submitted_qc>March 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aalborg University</investigator_affiliation>
    <investigator_full_name>Enrico De Martino</investigator_full_name>
    <investigator_title>Medical Doctor</investigator_title>
  </responsible_party>
  <keyword>nerve growth factor</keyword>
  <keyword>repetitive transcranial magnetic stimulation</keyword>
  <keyword>dorsolateral prefrontal cortex</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myalgia</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/NCT03263884
org study id: N-20170041
nct id: NCT03263884
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The main purpose of the study is to assess the mechanisms of repeated sessions of repetitive
      trancranial magnetic stimulation (rTMS) applied on left dorsolateral prefrontal cortex on the
      development of pain in a prolonged muscle pain model.
This study aims to investigate whether i) rTMS of left DLPFC will reduce the severity and
      duration of experimentally induced muscle pain when a 5-day course of treatment is given
      immediately following an initial nerve growth factor (NGF) injection; ii) the analgesic
      effects of left DLPFC rTMS will be related to an improved cognitive network function as
      assessed by electroencephalography (EEG).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Pain relief
time frame: Change from baseline at 2 weeks
description: Pain on an 11-point numerical rating scale (0 = no pain, 10 = most intense pain imaginable)
measure: Muscle soreness
time frame: Change from baseline at 2 weeks
description: 7-point Likert scale; 0 = 'a complete absence of soreness', 1 = 'a light soreness in the muscle felt only when touched/vague ache', 2 = 'a moderate soreness felt only when touched/a slight persistent ache', '3 = 'a light muscle soreness when lifting or carrying objects', 4 = 'a light muscle soreness, stiffness or weakness when moving the wrist without gripping an object', 5 = 'a moderate muscle soreness, stiffness or weakness when moving the wrist', 6 = 'a severe muscle soreness, stiffness or weakness that limits the ability to move'
measure: Patient-rated Tennis Elbow Evaluation
time frame: Change from baseline at 2 weeks
description: The Patient-rated Tennis Elbow Evaluation will be used to assess average pain and disability of the injected arm
measure: Attention network test
time frame: Change from baseline at 2 weeks
description: This task assesses cognitive function in 3 domains: alerting, orienting, and executive function
measure: Pressure pain thresholds
time frame: Change from baseline at 2 weeks
description: Pressure applied to the surface of the skin using a handheld algometer.
measure: Cuff pressure algometry
time frame: Change from baseline at 2 weeks
description: The experimental setup consists of a tourniquet cuff, a computer-controlled air compressor and an electronic visual analog scale VAS (Aalborg University, Denmark). The cuff is connected to the compressor and wrapped around the leg. The pain intensity is recorded with the electronic VAS and sampled at 10 Hz. The "0 cm" and "10 cm" extremes on the VAS are defined as "no pain" and as "maximal pain", respectively. The compression rate of the cuff is programmed on and controlled by a computer.
measure: EEG recordings
time frame: Change from baseline at 1 weeks
description: we will record brain activity in the following conditions: eyes closed rest, performance of a computer-based cognitive task (ANT).
arm group label: Real treatment group
arm group type: Experimental
description: Transcranial magnetic stimulation (TMS) is used to stimulate small regions of the brain. During a TMS procedure, a magnetic field generator, or "coil", is placed near the head of the person receiving the treatment. The coil produces small electric currents in the region of the brain just under the coil via electromagnetic induction.
The protocol used in this research includes 20 minutes of 10Hz stimulation, 5 seconds on, 10 seconds off, at 110% RMT, for a total of 4000 pulses.
arm group label: Sham treatment group
arm group type: Sham Comparator
description: Sham coil is used to mimic the clicking sound of the TMS coil and skin stimulation
intervention type: Device
intervention name: Repetitive trancranial magnetic stimulation (rTMS) group
description: Repetitive trancranial magnetic stimulation is applied on the dorsolateral prefrontal cortex. The protocol consists on 20 minutes of 10Hz stimulation, 5 seconds on, 10 seconds off, at 110% RMT, for a total of 4000 pulses.
arm group label: Real treatment group
intervention type: Device
intervention name: Sham group
description: A sham coil is used to mimic the clicking sound of the trancranial magnetic coil and skin stimulation.
arm group label: Sham treatment group
criteria: 
gender: All
minimum age: 21 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Enrico De Martino, MD
role: Principal Investigator
affiliation: Aalborg University
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Aalborg University
investigator full name: Enrico De Martino
investigator title: Medical Doctor
mesh term: Myalgia
sharing ipd: No