<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/NCT03243084</url>
  </required_header>
  <id_info>
    <org_study_id>17-0870</org_study_id>
    <secondary_id>R01MH101547</secondary_id>
    <nct_id>NCT03243084</nct_id>
  </id_info>
  <brief_title>Transcranial Alternating Current Stimulation in Back Pain- Pilot Sudy</brief_title>
  <acronym>BPS</acronym>
  <official_title>Effect of Transcranial Alternating Current Stimulation in Chronic Low Back Pain: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of North Carolina, Chapel Hill</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chronic pain is a severe disabling problem within society, affecting 25-30% of the United&#xD;
      States population.. Transcranial alternating current stimulation (tACS) has the potential to&#xD;
      provide a treatment option that is safe, scientifically-supported, low-cost, and&#xD;
      easy-to-administer method to effectively reduce symptoms in patients suffering from chronic&#xD;
      pain. The purpose of this study is to test the feasibility of using tACS to treat patients&#xD;
      with chronic pain, and to collect pilot efficacy as well as EEG and EKG biomarker data for&#xD;
      optimizing the design of subsequent large-scale studies. The treatment rationale is to&#xD;
      renormalize the presumed pathological structure of alpha oscillations in the prefrontal&#xD;
      cortex (PFC) of patients with chronic pain.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 7, 2017</start_date>
  <completion_date type="Actual">January 10, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>Each participant will receive sham stimulation and 10Hz tACS stimulation at two separate sessions. The order will be randomized (ie, half the participants will receive sham stimulation at the first session and 10Hz tACS stimulation at the second session, and the other half will receive 10Hz tACS stimulation at the first session and sham stimulation at the second session).</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>This is a double-blind study, meaning that neither the participant nor the experimenter knows what kind of stimulation the participant is receiving. An unblinded monitor (separate from the staff that interacts with the participant) is responsible for creating the stimulation codes that run each session and for ensuring that these codes worked correctly.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Heart Rate Variability Before and After 40-minute Stimulation</measure>
    <time_frame>before and after 40-minute stimulation at each session</time_frame>
    <description>Changes in parasympathetic tone, increase in high frequency band input via spectral analysis on EKG recordings between active and sham stimulation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Electroencephalogram Power in Alpha Band Before and After 40-minute Stimulation</measure>
    <time_frame>5 minute recordings before and after each 40-minute stimulation at each session.</time_frame>
    <description>Changes in the EEG power in the alpha (8-12 Hz) band before and after 40-minute stimulation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Pain Rating on the Visual Analog Scale Before and After 40-minute Stimulation</measure>
    <time_frame>before and after 40 minute stimulation session</time_frame>
    <description>Self reported pain rating using a Visual Analog Scale (VAS) ranging from 0-10 done before and after stimulation with '0' being no pain and '10' as bad as it could be. Lower values represent a better outcome. (Pain difference was normalized using modulation index to account for ordinal scale)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Chronic Low Back Pain</condition>
  <arm_group>
    <arm_group_label>Sham tACS</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation is delivered using the XCSITE100 Stimulator Sham.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active 10 Hz tACS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive 2mA of alternating current stimulation at a frequency of 10Hz for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>XCSITE100 Stimulator Sham</intervention_name>
    <description>The participant will receive up to one minute of tACS stimulation until the stimulation fades. Sham stimulation mimics the skin sensations a participant would experience during a tACS session</description>
    <arm_group_label>Sham tACS</arm_group_label>
    <other_name>Sham tACS</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>XCSITE100 Stimulator tACS</intervention_name>
    <description>Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied</description>
    <arm_group_label>Active 10 Hz tACS</arm_group_label>
    <other_name>tACS</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female, aged 18-65&#xD;
&#xD;
          -  Diagnosed with nonspecific chronic low back pain by clinician&#xD;
&#xD;
          -  BMI is less than 30&#xD;
&#xD;
          -  Suffered from chronic pain for &gt; 6 months&#xD;
&#xD;
          -  Self-report pain measures &gt;4&#xD;
&#xD;
          -  Meets criteria for low depression and suicide risk as defined by the&#xD;
             Hamilton-Depression Rating Scale&#xD;
&#xD;
          -  Capacity to understand all relevant risks and potential benefits of the study&#xD;
             (informed consent)&#xD;
&#xD;
          -  Not currently taking opioids, benzodiazepines, and anticonvulsant medications&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Radicular Pain&#xD;
&#xD;
          -  Traumatic brain injury, Any brain devices/implants, including cochlear implants and&#xD;
             aneurysm clips&#xD;
&#xD;
          -  History of major neurological or psychiatric illness, including epilepsy&#xD;
&#xD;
          -  (For females) Pregnancy or breast feeding&#xD;
&#xD;
          -  Diagnosis of eating disorder (current or within the past 6 months), Obsessive&#xD;
             Compulsive Disorder (lifetime), or Attention-Deficit Hyperactivity Disorder (currently&#xD;
             under treatment)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Karen McCulloch, PhD, DPT</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of North Carolina Chapel Hill</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27514</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>August 3, 2017</study_first_submitted>
  <study_first_submitted_qc>August 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <results_first_submitted>October 19, 2018</results_first_submitted>
  <results_first_submitted_qc>November 16, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">December 12, 2018</results_first_posted>
  <last_update_submitted>November 16, 2018</last_update_submitted>
  <last_update_submitted_qc>November 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>tACS</keyword>
  <keyword>transcranial alternating current stimulation</keyword>
  <keyword>low back pain</keyword>
  <keyword>chronic pain</keyword>
  <keyword>alpha oscillations</keyword>
  <keyword>heart rate variability</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Low Back Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>No Plan</ipd_description>
  </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>March 29, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/84/NCT03243084/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment ran from August 2017 - December 2017. This clinical trial utilized multiple recruitment strategies including UNC University Physical Therapy and Pain clinic locations, informational notify.unc.edu system, and jointheconquest.org along with the listing on clinicaltrials.gov</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Sham Then Active 10 Hz tACS</title>
          <description>At session 1 this group received sham tACS and at session 2 they received active 10Hz tACS</description>
        </group>
        <group group_id="P2">
          <title>Active 10 Hz Then Sham tACS</title>
          <description>At session 1 this group received active 10Hz tACS and at session 2 they received sham tACS</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Session 1</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Washout (1-3 Weeks)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Session 2</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Sham Then Active 10 Hz tACS</title>
          <description>At session 1 this group received sham tACS and at session 2 they received active 10Hz tACS</description>
        </group>
        <group group_id="B2">
          <title>Active 10 Hz Then Sham tACS</title>
          <description>At session 1 this group received active 10Hz tACS and at session 2 they received sham 10Hz tACS</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="11"/>
            <count group_id="B2" value="10"/>
            <count group_id="B3" value="21"/>
          </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="42.6" spread="13.8"/>
                    <measurement group_id="B2" value="43.4" spread="13.6"/>
                    <measurement group_id="B3" value="43" spread="13.4"/>
                  </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="9"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="9"/>
                  </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="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</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>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>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="11"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25.98" spread="4.1"/>
                    <measurement group_id="B2" value="25.92" spread="5.1"/>
                    <measurement group_id="B3" value="25.94" spread="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duration of Pain</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.8" spread="3.0"/>
                    <measurement group_id="B2" value="9.3" spread="7.4"/>
                    <measurement group_id="B3" value="7.1" spread="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Heart Rate Variability Before and After 40-minute Stimulation</title>
        <description>Changes in parasympathetic tone, increase in high frequency band input via spectral analysis on EKG recordings between active and sham stimulation</description>
        <time_frame>before and after 40-minute stimulation at each session</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Sham tACS</title>
            <description>Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation is delivered using the XCSITE100 Stimulator Sham.&#xD;
XCSITE100 Stimulator Sham: The participant will receive up to one minute of tACS stimulation until the stimulation fades. Sham stimulation mimics the skin sensations a participant would experience during a tACS session</description>
          </group>
          <group group_id="O2">
            <title>Active10 Hz tACS</title>
            <description>Participants will receive 2mA of alternating current stimulation at a frequency of 10Hz for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS.&#xD;
XCSITE100 Stimulator tACS: Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Heart Rate Variability Before and After 40-minute Stimulation</title>
          <description>Changes in parasympathetic tone, increase in high frequency band input via spectral analysis on EKG recordings between active and sham stimulation</description>
          <units>ms^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.206" spread="0.76"/>
                    <measurement group_id="O2" value="-0.01" spread="0.56"/>
                  </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>
            <groups_desc>A 2x2 ANOVA was used to measure change in HF-HRV by condition (10 Hz vs sham) and session (first vs second) as within subjects variables</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.319</p_value>
            <p_value_desc>Threshold for significance is &lt;.05.</p_value_desc>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Electroencephalogram Power in Alpha Band Before and After 40-minute Stimulation</title>
        <description>Changes in the EEG power in the alpha (8-12 Hz) band before and after 40-minute stimulation</description>
        <time_frame>5 minute recordings before and after each 40-minute stimulation at each session.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Sham tACS</title>
            <description>Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation is delivered using the XCSITE100 Stimulator Sham.&#xD;
XCSITE100 Stimulator Sham: The participant will receive up to one minute of tACS stimulation until the stimulation fades. Sham stimulation mimics the skin sensations a participant would experience during a tACS session</description>
          </group>
          <group group_id="O2">
            <title>Active 10 Hz tACS</title>
            <description>Participants will receive 2mA of alternating current stimulation at a frequency of 10Hz for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS.&#xD;
XCSITE100 Stimulator tACS: Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Electroencephalogram Power in Alpha Band Before and After 40-minute Stimulation</title>
          <description>Changes in the EEG power in the alpha (8-12 Hz) band before and after 40-minute stimulation</description>
          <units>square microvolts</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.03" spread="0.16"/>
                    <measurement group_id="O2" value="0.4" spread="0.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Pain Rating on the Visual Analog Scale Before and After 40-minute Stimulation</title>
        <description>Self reported pain rating using a Visual Analog Scale (VAS) ranging from 0-10 done before and after stimulation with '0' being no pain and '10' as bad as it could be. Lower values represent a better outcome. (Pain difference was normalized using modulation index to account for ordinal scale)</description>
        <time_frame>before and after 40 minute stimulation session</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Sham tACS</title>
            <description>Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation is delivered using the XCSITE100 Stimulator Sham.&#xD;
XCSITE100 Stimulator Sham: The participant will receive up to one minute of tACS stimulation until the stimulation fades. Sham stimulation mimics the skin sensations a participant would experience during a tACS session</description>
          </group>
          <group group_id="O2">
            <title>Active 10 Hz tACS</title>
            <description>Participants will receive 2mA of alternating current stimulation at a frequency of 10Hz for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS.&#xD;
XCSITE100 Stimulator tACS: Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Pain Rating on the Visual Analog Scale Before and After 40-minute Stimulation</title>
          <description>Self reported pain rating using a Visual Analog Scale (VAS) ranging from 0-10 done before and after stimulation with '0' being no pain and '10' as bad as it could be. Lower values represent a better outcome. (Pain difference was normalized using modulation index to account for ordinal scale)</description>
          <units>units 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="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.178" spread="0.97"/>
                    <measurement group_id="O2" value="0.18" spread="0.31"/>
                  </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>
            <groups_desc>Investigators hypothesized that active stimulation would have a greater normalized pain change using a modulation index [(Pre-Post)/(Pre+Post)]</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.0488</p_value>
            <p_value_desc>Threshold for significance is &lt;.05.</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Study enrollment until 2 day followup after last session</time_frame>
      <desc>A side effects questionnaire</desc>
      <group_list>
        <group group_id="E1">
          <title>Sham tACS</title>
          <description>Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation is delivered using the XCSITE100 Stimulator Sham.&#xD;
XCSITE100 Stimulator Sham: The participant will receive up to one minute of tACS stimulation until the stimulation fades. Sham stimulation mimics the skin sensations a participant would experience during a tACS session</description>
        </group>
        <group group_id="E2">
          <title>Active 10 Hz tACS</title>
          <description>Participants will receive 2mA of alternating current stimulation at a frequency of 10Hz for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS.&#xD;
XCSITE100 Stimulator tACS: Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied.</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="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </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="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </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>Limitations of the study include small sample size. Participants received only 1 session of Active 10 Hz tACS by design but there is likely an additive effect and future studies should investigate multiple sessions.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Julianna Prim</name_or_title>
      <organization>UNC Chapel Hill</organization>
      <phone>919-962-5271</phone>
      <email>jhprim@email.unc.edu</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/NCT03243084
org study id: 17-0870
secondary id: R01MH101547
nct id: NCT03243084
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
Chronic pain is a severe disabling problem within society, affecting 25-30% of the United
      States population.. Transcranial alternating current stimulation (tACS) has the potential to
      provide a treatment option that is safe, scientifically-supported, low-cost, and
      easy-to-administer method to effectively reduce symptoms in patients suffering from chronic
      pain. The purpose of this study is to test the feasibility of using tACS to treat patients
      with chronic pain, and to collect pilot efficacy as well as EEG and EKG biomarker data for
      optimizing the design of subsequent large-scale studies. The treatment rationale is to
      renormalize the presumed pathological structure of alpha oscillations in the prefrontal
      cortex (PFC) of patients with chronic pain.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Each participant will receive sham stimulation and 10Hz tACS stimulation at two separate sessions. The order will be randomized (ie, half the participants will receive sham stimulation at the first session and 10Hz tACS stimulation at the second session, and the other half will receive 10Hz tACS stimulation at the first session and sham stimulation at the second session).
primary purpose: Basic Science
masking: Double (Participant, Investigator)
masking description: This is a double-blind study, meaning that neither the participant nor the experimenter knows what kind of stimulation the participant is receiving. An unblinded monitor (separate from the staff that interacts with the participant) is responsible for creating the stimulation codes that run each session and for ensuring that these codes worked correctly.
measure: Change in Heart Rate Variability Before and After 40-minute Stimulation
time frame: before and after 40-minute stimulation at each session
description: Changes in parasympathetic tone, increase in high frequency band input via spectral analysis on EKG recordings between active and sham stimulation
measure: Change in Electroencephalogram Power in Alpha Band Before and After 40-minute Stimulation
time frame: 5 minute recordings before and after each 40-minute stimulation at each session.
description: Changes in the EEG power in the alpha (8-12 Hz) band before and after 40-minute stimulation
measure: Change in Pain Rating on the Visual Analog Scale Before and After 40-minute Stimulation
time frame: before and after 40 minute stimulation session
description: Self reported pain rating using a Visual Analog Scale (VAS) ranging from 0-10 done before and after stimulation with '0' being no pain and '10' as bad as it could be. Lower values represent a better outcome. (Pain difference was normalized using modulation index to account for ordinal scale)
arm group label: Sham tACS
arm group type: Sham Comparator
description: Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation is delivered using the XCSITE100 Stimulator Sham.
arm group label: Active 10 Hz tACS
arm group type: Active Comparator
description: Participants will receive 2mA of alternating current stimulation at a frequency of 10Hz for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS.
intervention type: Device
intervention name: XCSITE100 Stimulator Sham
description: The participant will receive up to one minute of tACS stimulation until the stimulation fades. Sham stimulation mimics the skin sensations a participant would experience during a tACS session
arm group label: Sham tACS
other name: Sham tACS
intervention type: Device
intervention name: XCSITE100 Stimulator tACS
description: Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied
arm group label: Active 10 Hz tACS
other name: tACS
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Karen McCulloch, PhD, DPT
role: Principal Investigator
affiliation: University of North Carolina, Chapel Hill
facility: 
country: United States
responsible party type: Sponsor
mesh term: Back Pain
mesh term: Low Back Pain
sharing ipd: Undecided
ipd description: No Plan
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Limitations of the study include small sample size. Participants received only 1 session of Active 10 Hz tACS by design but there is likely an additive effect and future studies should investigate multiple sessions.
point of contact: 