<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/NCT02979925</url>
  </required_header>
  <id_info>
    <org_study_id>B2366-P</org_study_id>
    <secondary_id>1192133</secondary_id>
    <nct_id>NCT02979925</nct_id>
  </id_info>
  <brief_title>Improving Functions in Veterans With Post-traumatic Peripheral Neuropathic Pain</brief_title>
  <acronym>PTP-NP</acronym>
  <official_title>Improving Functions in Veterans With Post-Traumatic Peripheral Neuropathic Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Office of Research and Development</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The proposed study will set the foundation for future multi-center studies. To validate tMS&#xD;
      as a non-contact and non-invasive pain treatment option for reducing pain in Veterans with&#xD;
      PTP-NP and improving their overall functions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will only be conducted at the VA hospital in San Diego.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2016</start_date>
  <completion_date type="Actual">September 30, 2019</completion_date>
  <primary_completion_date type="Actual">September 30, 2019</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of Spontaneous Pain Scores</measure>
    <time_frame>Assessed during each of the subject's baseline visit, 1 week post treatment visit, and 4 weeks post treatment visit.</time_frame>
    <description>Spontaneous pain rating: Spontaneous pain level will be measured by using a sliding algometer, known as the Mechanical Visual Analog Scale (M-VAS). The device has been well validated, and is anchored at the left by &quot;no pain sensation&quot; and at the right by &quot;the most intense pain sensation imaginable.&quot; The corresponding length of the red bar with a scale from 0 to 100, which can be read on the back by the tester, represents the subject's intensity of pain. 0 represents &quot;no pain sensation&quot; and 100 represents &quot;the most intense pain sensation imaginable.&quot; A lower value indicates a better outcome with lower levels of pain reported.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of Evoked Pain Scores: Stroking</measure>
    <time_frame>Assessed during each of the subject's baseline visit, 1 week post treatment visit, and 4 weeks post treatment visit.</time_frame>
    <description>Stroking evoked pain will be assessed by gently moving a paintbrush over the site of PTNP. The patients will be asked if pain is felt. If so, the intensity of pain will be rated on a scale known as the Mechanical Visual Analog Scale (M-VAS). The device has been well validated, and is anchored at the left by &quot;no pain sensation&quot; and at the right by &quot;the most intense pain sensation imaginable.&quot; The corresponding length of the red bar with a scale from 0 to 100, which can be read on the back by the tester, represents the subject's intensity of pain. 0 represents &quot;no pain sensation&quot; and 100 represents &quot;the most intense pain sensation imaginable.&quot; A lower value indicates a better outcome with lower levels of pain reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of Evoked Pain Scores: Von Frey</measure>
    <time_frame>Assessed during each of the subject's baseline visit, 1 week post treatment visit, and 4 weeks post treatment visit.</time_frame>
    <description>Punctate evoked pain will be conducted by gently pressing a 5.18 von Frey monofilament against the site of PTNP. The patients will be asked if pain is felt. If so, the intensity of pain will be rated on a scale known as the Mechanical Visual Analog Scale (M-VAS). The device has been well validated, and is anchored at the left by &quot;no pain sensation&quot; and at the right by &quot;the most intense pain sensation imaginable.&quot; The corresponding length of the red bar with a scale from 0 to 100, which can be read on the back by the tester, represents the subject's intensity of pain. 0 represents &quot;no pain sensation&quot; and 100 represents &quot;the most intense pain sensation imaginable.&quot; A lower value indicates a better outcome with lower levels of pain reported.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">57</enrollment>
  <condition>Neuropathic Pain</condition>
  <arm_group>
    <arm_group_label>Active transcutaneous magnetic stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Active transcutaneous magnetic stimulation (TMS) at the target site of nerve damage/injury.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham transcutaneous magnetic stimulation</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham TMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Active Transcutaneous Magnetic Stimulation</intervention_name>
    <description>Active transcutaneous magnetic stimulation (TMS) at the target site of nerve damage/injury.</description>
    <arm_group_label>Active transcutaneous magnetic stimulation</arm_group_label>
    <other_name>TMS</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham Transcutaneous Magnetic Stimulation</intervention_name>
    <description>Sham TMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.</description>
    <arm_group_label>Sham transcutaneous magnetic stimulation</arm_group_label>
    <other_name>TMS</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Evidence of a personally signed and dated informed consent document indicating that&#xD;
             the subject has been informed of all pertinent aspects of the study&#xD;
&#xD;
          -  Subject is willing and able to comply with scheduled visits, treatment plan, daily&#xD;
             pain, sleep and all study related assessments and procedures&#xD;
&#xD;
          -  Subjects must be literate in the language used in the assessments and pain diary&#xD;
&#xD;
          -  Veterans (men or women) of any race or ethnicity who are at least 18 years of age&#xD;
&#xD;
          -  Female subjects of childbearing potential must agree to use a highly effective method&#xD;
             of contraception throughout the study and for at least 7 days after the last session&#xD;
             of the assigned treatment&#xD;
&#xD;
               -  A subject is of childbearing potential if, in the opinion of the investigator,&#xD;
                  he/she is biologically capable of having children and is sexually active&#xD;
&#xD;
          -  Subject must have chronic peripheral neuropathic pain present for more than 4 months&#xD;
             after a traumatic or surgical event per medical history, this may include, for&#xD;
             example:&#xD;
&#xD;
               -  motor vehicle accident&#xD;
&#xD;
               -  fall&#xD;
&#xD;
               -  sports injury&#xD;
&#xD;
               -  knee or hip replacement&#xD;
&#xD;
               -  hernia repair&#xD;
&#xD;
               -  thoracotomy&#xD;
&#xD;
               -  mastectomy&#xD;
&#xD;
               -  focal/localized burns or crush injury&#xD;
&#xD;
          -  In addition, to be eligible for inclusion in the study, all subjects must:&#xD;
&#xD;
               -  have an average daily Numerical Pain Rating Scale (NPRS) score &gt;3 during B1; and&#xD;
&#xD;
               -  have a spontaneous pain intensity &gt;30 on 0-100 Mechanical Visual Analogue Scale&#xD;
                  (M-VAS) to be eligible for randomization&#xD;
&#xD;
          -  Must have their implicated peripheral nerve(s) identified&#xD;
&#xD;
          -  Must meet criteria for neuropathic pain assessment to meet eligibility for the study&#xD;
             [46]. Pain distribution across a nerve territory and history indicates relevant lesion&#xD;
             or disease plus criteria listed in a and/or b&#xD;
&#xD;
          -  (A): At least one negative or positive sensory sign or symptom confined to innervation&#xD;
             territory of the lesioned nervous structure. Examples of negative or positive signs or&#xD;
             symptoms include:&#xD;
&#xD;
               -  Burning, stabbing or tingling sensation/pain&#xD;
&#xD;
               -  Numbness/paresthesia&#xD;
&#xD;
               -  Cold, heat or pressure&#xD;
&#xD;
               -  Hyperalgesia or allodynia&#xD;
&#xD;
               -  Hypoesthesia&#xD;
&#xD;
               -  Increased or decreased sharp sensation (e.g., pinprick testing)&#xD;
&#xD;
               -  Decreased vibration/vibratory sensation&#xD;
&#xD;
          -  (B): Prior diagnostic tests confirming lesion or disease explaining neuropathic pain&#xD;
             (Nerve conduction studies, EMG, skin or nerve biopsy). Documentation of affected&#xD;
             nerve(s) indicating that the subject's pain is of neuropathic origin and is a result&#xD;
             of injury/trauma to the affected/implicated nerve(s).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Subjects presenting with ANY of the following will NOT be included in the study:&#xD;
&#xD;
          -  Subjects with neuropathic pain due to:&#xD;
&#xD;
               -  diabetic peripheral neuropathy&#xD;
&#xD;
               -  post herpetic neuralgia&#xD;
&#xD;
               -  Human Immunodeficiency Virus&#xD;
&#xD;
               -  chemo/anti-viral therapy&#xD;
&#xD;
               -  trigeminal neuralgia&#xD;
&#xD;
               -  carpal tunnel syndrome&#xD;
&#xD;
               -  subjects whose post-traumatic neuropathic pain is categorized as central (e.g.,&#xD;
                  spinal cord injury) rather than peripheral&#xD;
&#xD;
          -  Subjects with pain due to Complex Regional Pain Syndrome (CRPS, Type I or Type II)&#xD;
&#xD;
          -  Phantom limb pain after amputation. However, subjects with stump pain and phantom&#xD;
             sensation but no phantom pain will not be excluded&#xD;
&#xD;
          -  Subjects with skin conditions in the affected dermatome that in the judgment of the&#xD;
             investigator can interfere with evaluation of the neuropathic pain condition&#xD;
&#xD;
          -  Subjects with other pain such as lumbar or cervical radiculopathy that may confound&#xD;
             assessment or self-evaluation of the peripheral neuropathic pain&#xD;
&#xD;
               -  subjects with significant somatic pain at the site of their trauma that may&#xD;
                  confound assessment or self-evaluation of their neuropathic pain&#xD;
&#xD;
          -  Any subject considered at risk of suicide or self-harm based on investigator judgment&#xD;
             and/or the details of a risk assessment&#xD;
&#xD;
          -  Use of prohibited medications in the absence of appropriate washout periods&#xD;
&#xD;
          -  Participation in any other clinical trial within the 30 days prior to screening and/or&#xD;
             during participation in this study&#xD;
&#xD;
          -  Subjects with a history of a cardiac arrhythmia that has led to the placement of a&#xD;
             cardiac pacer or defibrillator will be excluded from the study&#xD;
&#xD;
          -  Pregnant females and females of childbearing potential not using highly effective&#xD;
             contraception or not agreeing to continue highly effective contraception during the&#xD;
             study&#xD;
&#xD;
          -  Subjects with a current diagnosis of DSM-IV-TR Axis I disorder, including, for&#xD;
             example:&#xD;
&#xD;
               -  schizophrenia&#xD;
&#xD;
               -  bipolar disorder&#xD;
&#xD;
               -  other psychotic disorders such as schizoaffective disorder and delusion disorder&#xD;
&#xD;
               -  somatoform disorders or factitious disorders&#xD;
&#xD;
               -  bipolar disorders, even if controlled or stable&#xD;
&#xD;
               -  alcohol or substance related disorders in the past 2 years&#xD;
&#xD;
               -  however, diagnoses of Generalized Anxiety Disorder (GAD) or major depression&#xD;
                  (MDD) that is clinically stable are allowed&#xD;
&#xD;
          -  Subjects with pending Worker's Compensation, Worker's Compensation, civil litigation&#xD;
             or disability claims pertinent to the subject based upon trauma&#xD;
&#xD;
               -  current involvement in out-of-court settlements for claims pertinent to subject's&#xD;
                  trauma&#xD;
&#xD;
               -  subjects with fully resolved litigation and compensation claims can participate&#xD;
&#xD;
          -  Subjects who have previously received either transcranial or transcutaneous magnetic&#xD;
             stimulation therapy in the past&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Albert Yick Leung, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>VA San Diego Healthcare System, San Diego, CA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>VA San Diego Healthcare System, San Diego, CA</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92161</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <results_first_submitted>May 25, 2021</results_first_submitted>
  <results_first_submitted_qc>May 25, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">June 18, 2021</results_first_posted>
  <disposition_first_submitted>September 14, 2020</disposition_first_submitted>
  <disposition_first_submitted_qc>September 14, 2020</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">September 16, 2020</disposition_first_posted>
  <last_update_submitted>June 17, 2021</last_update_submitted>
  <last_update_submitted_qc>June 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>neuropathic pain</keyword>
  <keyword>TMS</keyword>
  <keyword>nerve injury</keyword>
  <keyword>transcutaneous magnetic stimulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neuralgia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 7, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/25/NCT02979925/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were recruited from October 2016 to June 2018 at the VA San Diego Medical Center.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Active Transcutaneous Magnetic Stimulation</title>
          <description>Active transcutaneous magnetic stimulation (tMS) at the target site of nerve damage/injury.&#xD;
Active Transcutaneous Magnetic Stimulation: Active transcutaneous magnetic stimulation (tMS) at the target site of nerve damage/injury.</description>
        </group>
        <group group_id="P2">
          <title>Sham Transcutaneous Magnetic Stimulation</title>
          <description>Sham tMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.&#xD;
Sham Transcutaneous Magnetic Stimulation: Sham tMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
                <participants group_id="P2" count="29"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
                <participants group_id="P2" count="23"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Active Transcutaneous Magnetic Stimulation</title>
          <description>Active transcutaneous magnetic stimulation (tMS) at the target site of nerve damage/injury.&#xD;
Active Transcutaneous Magnetic Stimulation: Active transcutaneous magnetic stimulation (tMS) at the target site of nerve damage/injury.</description>
        </group>
        <group group_id="B2">
          <title>Sham Transcutaneous Magnetic Stimulation</title>
          <description>Sham tMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.&#xD;
Sham Transcutaneous Magnetic Stimulation: Sham tMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="28"/>
            <count group_id="B2" value="23"/>
            <count group_id="B3" value="51"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54.11" spread="17.02"/>
                    <measurement group_id="B2" value="50.78" spread="14.04"/>
                    <measurement group_id="B3" value="52.61" spread="15.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Spontaneous Pain Score</title>
          <description>Spontaneous pain level was measured using a sliding algometer, known as the Mechanical Visual Analog Scale (M-VAS). The device has been well validated, and is anchored at the left by &quot;no pain sensation&quot; and at the right by &quot;the most intense pain sensation imaginable.&quot; The corresponding length of the red bar with a scale from 0 to 100, which can be read on the back by the tester, represents the subject's intensity of pain. 0 represents &quot;no pain sensation&quot; and 100 represents &quot;the most intense pain sensation imaginable.&quot; A lower value indicates a better outcome with lower levels of pain reported.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53.52" spread="21.01"/>
                    <measurement group_id="B2" value="49.13" spread="22.61"/>
                    <measurement group_id="B3" value="50.44" spread="22.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Evaluation of Spontaneous Pain Scores</title>
        <description>Spontaneous pain rating: Spontaneous pain level will be measured by using a sliding algometer, known as the Mechanical Visual Analog Scale (M-VAS). The device has been well validated, and is anchored at the left by &quot;no pain sensation&quot; and at the right by &quot;the most intense pain sensation imaginable.&quot; The corresponding length of the red bar with a scale from 0 to 100, which can be read on the back by the tester, represents the subject's intensity of pain. 0 represents &quot;no pain sensation&quot; and 100 represents &quot;the most intense pain sensation imaginable.&quot; A lower value indicates a better outcome with lower levels of pain reported.</description>
        <time_frame>Assessed during each of the subject's baseline visit, 1 week post treatment visit, and 4 weeks post treatment visit.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Active Transcutaneous Magnetic Stimulation</title>
            <description>Active transcutaneous magnetic stimulation (tMS) at the target site of nerve damage/injury.&#xD;
Active Transcutaneous Magnetic Stimulation: Active transcutaneous magnetic stimulation (tMS) at the target site of nerve damage/injury.</description>
          </group>
          <group group_id="O2">
            <title>Sham Transcutaneous Magnetic Stimulation</title>
            <description>Sham tMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.&#xD;
Sham Transcutaneous Magnetic Stimulation: Sham tMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.</description>
          </group>
        </group_list>
        <measure>
          <title>Evaluation of Spontaneous Pain Scores</title>
          <description>Spontaneous pain rating: Spontaneous pain level will be measured by using a sliding algometer, known as the Mechanical Visual Analog Scale (M-VAS). The device has been well validated, and is anchored at the left by &quot;no pain sensation&quot; and at the right by &quot;the most intense pain sensation imaginable.&quot; The corresponding length of the red bar with a scale from 0 to 100, which can be read on the back by the tester, represents the subject's intensity of pain. 0 represents &quot;no pain sensation&quot; and 100 represents &quot;the most intense pain sensation imaginable.&quot; A lower value indicates a better outcome with lower levels of pain reported.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.52" spread="21.01"/>
                    <measurement group_id="O2" value="49.13" spread="22.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 week post treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.41" spread="30.09"/>
                    <measurement group_id="O2" value="46.17" spread="26.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 weeks post treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.92" spread="29.16"/>
                    <measurement group_id="O2" value="37.52" spread="30.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.246</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Evaluation of Evoked Pain Scores: Stroking</title>
        <description>Stroking evoked pain will be assessed by gently moving a paintbrush over the site of PTNP. The patients will be asked if pain is felt. If so, the intensity of pain will be rated on a scale known as the Mechanical Visual Analog Scale (M-VAS). The device has been well validated, and is anchored at the left by &quot;no pain sensation&quot; and at the right by &quot;the most intense pain sensation imaginable.&quot; The corresponding length of the red bar with a scale from 0 to 100, which can be read on the back by the tester, represents the subject's intensity of pain. 0 represents &quot;no pain sensation&quot; and 100 represents &quot;the most intense pain sensation imaginable.&quot; A lower value indicates a better outcome with lower levels of pain reported.</description>
        <time_frame>Assessed during each of the subject's baseline visit, 1 week post treatment visit, and 4 weeks post treatment visit.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Active Transcutaneous Magnetic Stimulation</title>
            <description>Active transcutaneous magnetic stimulation (tMS) at the target site of nerve damage/injury.&#xD;
Active Transcutaneous Magnetic Stimulation: Active transcutaneous magnetic stimulation (tMS) at the target site of nerve damage/injury.</description>
          </group>
          <group group_id="O2">
            <title>Sham Transcutaneous Magnetic Stimulation</title>
            <description>Sham tMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.&#xD;
Sham Transcutaneous Magnetic Stimulation: Sham tMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.</description>
          </group>
        </group_list>
        <measure>
          <title>Evaluation of Evoked Pain Scores: Stroking</title>
          <description>Stroking evoked pain will be assessed by gently moving a paintbrush over the site of PTNP. The patients will be asked if pain is felt. If so, the intensity of pain will be rated on a scale known as the Mechanical Visual Analog Scale (M-VAS). The device has been well validated, and is anchored at the left by &quot;no pain sensation&quot; and at the right by &quot;the most intense pain sensation imaginable.&quot; The corresponding length of the red bar with a scale from 0 to 100, which can be read on the back by the tester, represents the subject's intensity of pain. 0 represents &quot;no pain sensation&quot; and 100 represents &quot;the most intense pain sensation imaginable.&quot; A lower value indicates a better outcome with lower levels of pain reported.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.55" spread="31.07"/>
                    <measurement group_id="O2" value="24.78" spread="25.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 week post treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.74" spread="23.78"/>
                    <measurement group_id="O2" value="20.04" spread="24.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 weeks post treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.92" spread="21.90"/>
                    <measurement group_id="O2" value="21.35" spread="25.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.651</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Evaluation of Evoked Pain Scores: Von Frey</title>
        <description>Punctate evoked pain will be conducted by gently pressing a 5.18 von Frey monofilament against the site of PTNP. The patients will be asked if pain is felt. If so, the intensity of pain will be rated on a scale known as the Mechanical Visual Analog Scale (M-VAS). The device has been well validated, and is anchored at the left by &quot;no pain sensation&quot; and at the right by &quot;the most intense pain sensation imaginable.&quot; The corresponding length of the red bar with a scale from 0 to 100, which can be read on the back by the tester, represents the subject's intensity of pain. 0 represents &quot;no pain sensation&quot; and 100 represents &quot;the most intense pain sensation imaginable.&quot; A lower value indicates a better outcome with lower levels of pain reported.</description>
        <time_frame>Assessed during each of the subject's baseline visit, 1 week post treatment visit, and 4 weeks post treatment visit.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Active Transcutaneous Magnetic Stimulation</title>
            <description>Active transcutaneous magnetic stimulation (tMS) at the target site of nerve damage/injury.&#xD;
Active Transcutaneous Magnetic Stimulation: Active transcutaneous magnetic stimulation (tMS) at the target site of nerve damage/injury.</description>
          </group>
          <group group_id="O2">
            <title>Sham Transcutaneous Magnetic Stimulation</title>
            <description>Sham tMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.&#xD;
Sham Transcutaneous Magnetic Stimulation: Sham tMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.</description>
          </group>
        </group_list>
        <measure>
          <title>Evaluation of Evoked Pain Scores: Von Frey</title>
          <description>Punctate evoked pain will be conducted by gently pressing a 5.18 von Frey monofilament against the site of PTNP. The patients will be asked if pain is felt. If so, the intensity of pain will be rated on a scale known as the Mechanical Visual Analog Scale (M-VAS). The device has been well validated, and is anchored at the left by &quot;no pain sensation&quot; and at the right by &quot;the most intense pain sensation imaginable.&quot; The corresponding length of the red bar with a scale from 0 to 100, which can be read on the back by the tester, represents the subject's intensity of pain. 0 represents &quot;no pain sensation&quot; and 100 represents &quot;the most intense pain sensation imaginable.&quot; A lower value indicates a better outcome with lower levels of pain reported.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.97" spread="27.04"/>
                    <measurement group_id="O2" value="43.13" spread="26.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 week post treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.89" spread="25.98"/>
                    <measurement group_id="O2" value="36.22" spread="26.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 weeks post treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.27" spread="24.72"/>
                    <measurement group_id="O2" value="38.26" spread="23.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.902</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data was collected from first treatment to 4 weeks after the last treatment.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Active Transcutaneous Magnetic Stimulation</title>
          <description>Active transcutaneous magnetic stimulation (tMS) at the target site of nerve damage/injury.&#xD;
Active Transcutaneous Magnetic Stimulation: Active transcutaneous magnetic stimulation (tMS) at the target site of nerve damage/injury.</description>
        </group>
        <group group_id="E2">
          <title>Sham Transcutaneous Magnetic Stimulation</title>
          <description>Sham tMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.&#xD;
Sham Transcutaneous Magnetic Stimulation: Sham tMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>One limitation of this study is small sample size. In addition, the location of nerve damage (whether it is extremities or truncal region) could be a confounding factor for the effectiveness of the treatment.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Albert Leung, MD</name_or_title>
      <organization>VA San Diego Healthcare System</organization>
      <phone>858-552-8585 ext 3866</phone>
      <email>albert.leung@va.gov</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02979925
org study id: B2366-P
secondary id: 1192133
nct id: NCT02979925
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The proposed study will set the foundation for future multi-center studies. To validate tMS
      as a non-contact and non-invasive pain treatment option for reducing pain in Veterans with
      PTP-NP and improving their overall functions.
This study will only be conducted at the VA hospital in San Diego.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Evaluation of Spontaneous Pain Scores
time frame: Assessed during each of the subject's baseline visit, 1 week post treatment visit, and 4 weeks post treatment visit.
description: Spontaneous pain rating: Spontaneous pain level will be measured by using a sliding algometer, known as the Mechanical Visual Analog Scale (M-VAS). The device has been well validated, and is anchored at the left by "no pain sensation" and at the right by "the most intense pain sensation imaginable." The corresponding length of the red bar with a scale from 0 to 100, which can be read on the back by the tester, represents the subject's intensity of pain. 0 represents "no pain sensation" and 100 represents "the most intense pain sensation imaginable." A lower value indicates a better outcome with lower levels of pain reported.
measure: Evaluation of Evoked Pain Scores: Stroking
time frame: Assessed during each of the subject's baseline visit, 1 week post treatment visit, and 4 weeks post treatment visit.
description: Stroking evoked pain will be assessed by gently moving a paintbrush over the site of PTNP. The patients will be asked if pain is felt. If so, the intensity of pain will be rated on a scale known as the Mechanical Visual Analog Scale (M-VAS). The device has been well validated, and is anchored at the left by "no pain sensation" and at the right by "the most intense pain sensation imaginable." The corresponding length of the red bar with a scale from 0 to 100, which can be read on the back by the tester, represents the subject's intensity of pain. 0 represents "no pain sensation" and 100 represents "the most intense pain sensation imaginable." A lower value indicates a better outcome with lower levels of pain reported.
measure: Evaluation of Evoked Pain Scores: Von Frey
time frame: Assessed during each of the subject's baseline visit, 1 week post treatment visit, and 4 weeks post treatment visit.
description: Punctate evoked pain will be conducted by gently pressing a 5.18 von Frey monofilament against the site of PTNP. The patients will be asked if pain is felt. If so, the intensity of pain will be rated on a scale known as the Mechanical Visual Analog Scale (M-VAS). The device has been well validated, and is anchored at the left by "no pain sensation" and at the right by "the most intense pain sensation imaginable." The corresponding length of the red bar with a scale from 0 to 100, which can be read on the back by the tester, represents the subject's intensity of pain. 0 represents "no pain sensation" and 100 represents "the most intense pain sensation imaginable." A lower value indicates a better outcome with lower levels of pain reported.
arm group label: Active transcutaneous magnetic stimulation
arm group type: Experimental
description: Active transcutaneous magnetic stimulation (TMS) at the target site of nerve damage/injury.
arm group label: Sham transcutaneous magnetic stimulation
arm group type: Sham Comparator
description: Sham TMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.
intervention type: Device
intervention name: Active Transcutaneous Magnetic Stimulation
description: Active transcutaneous magnetic stimulation (TMS) at the target site of nerve damage/injury.
arm group label: Active transcutaneous magnetic stimulation
other name: TMS
intervention type: Device
intervention name: Sham Transcutaneous Magnetic Stimulation
description: Sham TMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.
arm group label: Sham transcutaneous magnetic stimulation
other name: TMS
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Albert Yick Leung, MD
role: Principal Investigator
affiliation: VA San Diego Healthcare System, San Diego, CA
facility: 
country: United States
responsible party type: Sponsor
mesh term: Neuralgia
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: One limitation of this study is small sample size. In addition, the location of nerve damage (whether it is extremities or truncal region) could be a confounding factor for the effectiveness of the treatment.
point of contact: 