<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/NCT03302780</url>
  </required_header>
  <id_info>
    <org_study_id>HSC-MS-14-0564 Healthy</org_study_id>
    <nct_id>NCT03302780</nct_id>
  </id_info>
  <brief_title>BreEStim and tDCS for Neuropathic Pain Management - Healthy Subjects</brief_title>
  <official_title>Combined Peripheral (BreEStim) and Central Electrical Stimulation (tDCS) for Neuropathic Pain Management</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas Health Science Center, Houston</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Texas Health Science Center, Houston</source>
  <oversight_info>
    <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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study looks at the effect of combined breathing-controlled electrical stimulation&#xD;
      (BreEStim) and transcranial direct current stimulation (tDCS) on neuropathic pain after&#xD;
      spinal cord injury, amputation, or brain injury. The hypothesis is that a single session of&#xD;
      combined BreEStim and tDCS will produce an additive analgesic effect. This record covers the&#xD;
      study in a population of healthy volunteers. Note that this study will also enroll spinal&#xD;
      cord injury patients, brain injury patients, and amputation patients and that this study as&#xD;
      applied to these other populations will be covered in separate ClinicalTrials.gov records.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 6, 2016</start_date>
  <completion_date type="Actual">May 26, 2016</completion_date>
  <primary_completion_date type="Actual">May 26, 2016</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Electrical Pain Threshold (EPT)</measure>
    <time_frame>baseline, 10 minutes after tDCS, 10 minutes after BreEstim</time_frame>
    <description>Electrical Pain Threshold (EPT) is a type of quantitative sensory test that assesses the lowest electrical current that first evokes a sensation of pricking pain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Electrical Sensation Threshold (EST)</measure>
    <time_frame>baseline, 10 minutes after tDCS, 10 minutes after BreEstim</time_frame>
    <description>Electrical Detection Threshold (EDT) is a type of Quantitative sensory test that assesses the lowest electrical current that first evokes an electrical sensation.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Pain Management</condition>
  <arm_group>
    <arm_group_label>Sham tDCS and BreEStim</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm includes a 20-min sham tDCS to the current dominant primary motor cortex (M1), followed by a 20-min BreEStim to the median nerve (160 times) transcutaneously on the current dominant side.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>active tDCS (M1) and BreEStim</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm includes a 20-min active tDCS to the current dominant primary motor cortex (M1), followed by a 20-min BreEStim to the median nerve (160 times) transcutaneously on the current dominant side.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>BreEStim</intervention_name>
    <description>BreEStim will applied for 10 to 20 minutes.</description>
    <arm_group_label>Sham tDCS and BreEStim</arm_group_label>
    <arm_group_label>active tDCS (M1) and BreEStim</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>tDCS active</intervention_name>
    <description>tDCS will be applied for 20 minutes.</description>
    <arm_group_label>active tDCS (M1) and BreEStim</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>tDCS sham</intervention_name>
    <arm_group_label>Sham tDCS and BreEStim</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  between 18 and 75 years&#xD;
&#xD;
          -  male and female subjects&#xD;
&#xD;
          -  healthy subjects (i.e., no recent injuries or pain)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  recent injuries or pain&#xD;
&#xD;
          -  have a pacemaker, or other metal and/or implanted devices&#xD;
&#xD;
          -  have amputation in their arm(s)&#xD;
&#xD;
          -  have spinal cord injury (SCI) involving impairment of arms&#xD;
&#xD;
          -  have cognitive impairment from brain injury or are not able to follow commands, or to&#xD;
             give consent&#xD;
&#xD;
          -  have asthma or other pulmonary disease&#xD;
&#xD;
          -  are not medically stable&#xD;
&#xD;
          -  have preexisting psychiatric disorders&#xD;
&#xD;
          -  alcohol or drug abuse&#xD;
&#xD;
          -  have a history of seizures/Epilepsy, or taking benzodiazepines, anticonvulsants, and&#xD;
             antidepressants.&#xD;
&#xD;
          -  Mini-mental state examination (MMSE), a brief 30-point questionnaire test that is&#xD;
             commonly used in the literature, will be used to screen for cognitive impairment. A&#xD;
             brain injury patient with a score of 24 or lower on MMSE will be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sheng Li, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Texas Health Science Center, Houston</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>TIRR</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>October 1, 2017</study_first_submitted>
  <study_first_submitted_qc>October 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 5, 2017</study_first_posted>
  <results_first_submitted>November 6, 2020</results_first_submitted>
  <results_first_submitted_qc>November 6, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">December 3, 2020</results_first_posted>
  <disposition_first_submitted>August 17, 2020</disposition_first_submitted>
  <disposition_first_submitted_qc>August 17, 2020</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">August 21, 2020</disposition_first_posted>
  <last_update_submitted>April 2, 2021</last_update_submitted>
  <last_update_submitted_qc>April 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Texas Health Science Center, Houston</investigator_affiliation>
    <investigator_full_name>Sheng Li</investigator_full_name>
    <investigator_title>PhysicianProfessor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neuralgia</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Sham tDCS and BreEStim; Then M1 tDCS and BreEstim</title>
          <description>This study has a single-blinded, single-center, sham-controlled, crossover design. It included 2 separate visits, each with either a 20-min sham tDCS or M1 tDCS to the current dominant primary motor cortex(M1), both followed by a 20-min BreEStim to the median nerve(160 times) transcutaneously on the current dominant side.</description>
        </group>
        <group group_id="P2">
          <title>M1 tDCS and BreEStim; Then Sham tDCS and BreEstim</title>
          <description>This study has a single-blinded, single-center, sham-controlled, crossover design. It included 2 separate visits, each with either a 20-min sham tDCS or M1 tDCS to the current dominant primary motor cortex(M1), both followed by a 20-min BreEStim to the median nerve(160 times) transcutaneously on the current dominant side.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
              </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>All Participants</title>
          <description>This study has a single-blinded, single-center, sham-controlled, crossover design. It included 2 separate visits, each with either a 20-min sham tDCS or M1 tDCS to the current dominant primary motor cortex(M1), both followed by a 20-min BreEStim to the median nerve(160 times) transcutaneously on the current dominant side.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="6"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34" lower_limit="24" upper_limit="45"/>
                  </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="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Electrical Pain Threshold (EPT)</title>
        <description>Electrical Pain Threshold (EPT) is a type of quantitative sensory test that assesses the lowest electrical current that first evokes a sensation of pricking pain.</description>
        <time_frame>baseline, 10 minutes after tDCS, 10 minutes after BreEstim</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Sham tDCS and BreEStim</title>
            <description>This study has a single-blinded, single-center, sham-controlled, crossover design. It included a 20-min sham tDCS to the current dominant primary motor cortex(M1), followed by a 20-min BreEStim to the median nerve(160 times) transcutaneously on the current dominant side.</description>
          </group>
          <group group_id="O2">
            <title>Active tDCS (M1) and BreEStim</title>
            <description>This study has a single-blinded, single-center, sham-controlled, crossover design. It included a 20-min active tDCS to the current dominant primary motor cortex(M1), followed by a 20-min BreEStim to the median nerve(160 times) transcutaneously on the current dominant side.</description>
          </group>
        </group_list>
        <measure>
          <title>Electrical Pain Threshold (EPT)</title>
          <description>Electrical Pain Threshold (EPT) is a type of quantitative sensory test that assesses the lowest electrical current that first evokes a sensation of pricking pain.</description>
          <units>mA</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.83" spread="6.79"/>
                    <measurement group_id="O2" value="22.41" spread="4.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>After tDCS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.08" spread="7.68"/>
                    <measurement group_id="O2" value="20.41" spread="3.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>After BreEstim</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.70" spread="7.68"/>
                    <measurement group_id="O2" value="23.77" spread="6.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Electrical Sensation Threshold (EST)</title>
        <description>Electrical Detection Threshold (EDT) is a type of Quantitative sensory test that assesses the lowest electrical current that first evokes an electrical sensation.</description>
        <time_frame>baseline, 10 minutes after tDCS, 10 minutes after BreEstim</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Sham tDCS and BreEStim</title>
            <description>This study has a single-blinded, single-center, sham-controlled, crossover design. It included a 20-min sham tDCS to the current dominant primary motor cortex(M1), followed by a 20-min BreEStim to the median nerve(160 times) transcutaneously on the current dominant side.</description>
          </group>
          <group group_id="O2">
            <title>Active tDCS (M1) and BreEStim</title>
            <description>This study has a single-blinded, single-center, sham-controlled, crossover design. It included a 20-min active tDCS to the current dominant primary motor cortex(M1), followed by a 20-min BreEStim to the median nerve(160 times) transcutaneously on the current dominant side.</description>
          </group>
        </group_list>
        <measure>
          <title>Electrical Sensation Threshold (EST)</title>
          <description>Electrical Detection Threshold (EDT) is a type of Quantitative sensory test that assesses the lowest electrical current that first evokes an electrical sensation.</description>
          <units>mA</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.05" spread="1.07"/>
                    <measurement group_id="O2" value="3.54" spread="0.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>After tDCS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.99" spread="0.86"/>
                    <measurement group_id="O2" value="3.39" spread="0.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>After BreEstim</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.95" spread="0.74"/>
                    <measurement group_id="O2" value="3.59" spread="0.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 hour after treatment</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Sham tDCS and BreEStim</title>
          <description>This study has a single-blinded, single-center, sham-controlled, crossover design. It included a 20-min sham tDCS to the current dominant primary motor cortex(M1), followed by a 20-min BreEStim to the median nerve(160 times) transcutaneously on the current dominant side.</description>
        </group>
        <group group_id="E2">
          <title>Active tDCS (M1) and BreEStim</title>
          <description>This study has a single-blinded, single-center, sham-controlled, crossover design. It included a 20-min active tDCS to the current dominant primary motor cortex(M1), followed by a 20-min BreEStim to the median nerve(160 times) transcutaneously on the current dominant side.</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="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
              </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="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
              </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>Study stopped early, and small numbers of subjects analyzed.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Sheng Li, MD, PhD</name_or_title>
      <organization>University of Texas McGovern Medical School - Houston</organization>
      <phone>7137977125 ext 713</phone>
      <email>sheng.li@uth.tmc.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/NCT03302780
org study id: HSC-MS-14-0564 Healthy
nct id: NCT03302780
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
This study looks at the effect of combined breathing-controlled electrical stimulation
      (BreEStim) and transcranial direct current stimulation (tDCS) on neuropathic pain after
      spinal cord injury, amputation, or brain injury. The hypothesis is that a single session of
      combined BreEStim and tDCS will produce an additive analgesic effect. This record covers the
      study in a population of healthy volunteers. Note that this study will also enroll spinal
      cord injury patients, brain injury patients, and amputation patients and that this study as
      applied to these other populations will be covered in separate ClinicalTrials.gov records.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Electrical Pain Threshold (EPT)
time frame: baseline, 10 minutes after tDCS, 10 minutes after BreEstim
description: Electrical Pain Threshold (EPT) is a type of quantitative sensory test that assesses the lowest electrical current that first evokes a sensation of pricking pain.
measure: Electrical Sensation Threshold (EST)
time frame: baseline, 10 minutes after tDCS, 10 minutes after BreEstim
description: Electrical Detection Threshold (EDT) is a type of Quantitative sensory test that assesses the lowest electrical current that first evokes an electrical sensation.
arm group label: Sham tDCS and BreEStim
arm group type: Experimental
description: This arm includes a 20-min sham tDCS to the current dominant primary motor cortex (M1), followed by a 20-min BreEStim to the median nerve (160 times) transcutaneously on the current dominant side.
arm group label: active tDCS (M1) and BreEStim
arm group type: Experimental
description: This arm includes a 20-min active tDCS to the current dominant primary motor cortex (M1), followed by a 20-min BreEStim to the median nerve (160 times) transcutaneously on the current dominant side.
intervention type: Device
intervention name: BreEStim
description: BreEStim will applied for 10 to 20 minutes.
arm group label: Sham tDCS and BreEStim
arm group label: active tDCS (M1) and BreEStim
intervention type: Device
intervention name: tDCS active
description: tDCS will be applied for 20 minutes.
arm group label: active tDCS (M1) and BreEStim
intervention type: Device
intervention name: tDCS sham
arm group label: Sham tDCS and BreEStim
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sheng Li, MD, PhD
role: Principal Investigator
affiliation: The University of Texas Health Science Center, Houston
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: The University of Texas Health Science Center, Houston
investigator full name: Sheng Li
investigator title: PhysicianProfessor
mesh term: Neuralgia
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Study stopped early, and small numbers of subjects analyzed.
point of contact: 