<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/NCT03302793</url>
  </required_header>
  <id_info>
    <org_study_id>HSC-MS-14-0564 SCI</org_study_id>
    <nct_id>NCT03302793</nct_id>
  </id_info>
  <brief_title>Combined Peripheral (BreEStim) and Central Electrical Stimulation (tDCS) for Neuropathic Pain Management - Spinal Cord Injury</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 spinal cord injury patients. Note that this study will also enroll&#xD;
      healthy volunteers, 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>April 2015</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">December 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain as Assessed by Visual Analogue Scale (VAS)</measure>
    <time_frame>baseline, 10 minutes after tDCS, 10 minutes after BreEstim</time_frame>
    <description>A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. To allow a continuous assessment of pain, VAS uses a 10 cm line labelled at '0' with 'no pain' and '10' with 'worst pain'. The line is marked at a point corresponding to the assessment of the pain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Electrical Pain Threshold</measure>
    <time_frame>baseline, 10 minutes after tDCS, 10 minutes after BreEstim</time_frame>
    <description>Trimmed surface electrodes (1 inch by 1 inch) were used to examine electrical pain thresholds upon application of electrical stimulation (electrical stimulator 7SA, Digitimer). To measure electrical pain threshold, a pair of electrodes was placed next to each other centered on the thenar eminence (which is a group of muscles on the palm of the human hand at the base of the thumb); the intensity of electrical stimulation was started from the sensation threshold level (determined in outcome measure 3) and increased in steps of 1 mA; and subjects were instructed to close their eyes and to say ''yes'' when they first felt electrical stimulation painful. The electrical pain threshold is the mA level at which a participant first felt electrical stimulation painful. To improve consistency among subjects, they were advised that the pain threshold level was equivalent to 1 on the 0-10 VAS scale. Three repetitions were made and the average was used as the electrical pain threshold.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Electrical Sensation Threshold</measure>
    <time_frame>baseline, 10 minutes after tDCS, 10 minutes after BreEstim</time_frame>
    <description>Trimmed surface electrodes (1 inch by 1 inch) were used to examine electrical sensation threshold upon application of electrical stimulation (electrical stimulator 7SA, Digitimer). To measure electrical sensation threshold, a pair of electrodes was placed next to each other centered on the thenar eminence (which is a group of muscles on the palm of the human hand at the base of the thumb); the intensity of electrical stimulation was started from zero and gradually increased in steps of 0.1 mA; and subjects were instructed to close their eyes and to say ''yes'' when they explicitly felt electrical stimulation. The electrical sensation threshold is the mA level at which a participant explicitly felt electrical stimulation. Three repetitions were made and the average was used as the electrical sensation threshold.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Pain Management</condition>
  <arm_group>
    <arm_group_label>BreEStim and tDCS sham, then combined BreEStim and tDCS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BreEStim is voluntary breathing controlled electrical stimulation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Combined BreEStim and tDCS, then BreEStim and tDCS sham</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BreEStim is voluntary breathing controlled electrical stimulation. tDCS is transcranial direct current stimulation.</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>BreEStim and tDCS sham, then combined BreEStim and tDCS</arm_group_label>
    <arm_group_label>Combined BreEStim and tDCS, then BreEStim and tDCS sham</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>tDCS</intervention_name>
    <description>tDCS will be applied for 20 minutes.</description>
    <arm_group_label>BreEStim and tDCS sham, then combined BreEStim and tDCS</arm_group_label>
    <arm_group_label>Combined BreEStim and tDCS, then BreEStim and tDCS sham</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>tDCS sham</intervention_name>
    <arm_group_label>BreEStim and tDCS sham, then combined BreEStim and tDCS</arm_group_label>
    <arm_group_label>Combined BreEStim and tDCS, then BreEStim and tDCS sham</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  between 18 and 75 years&#xD;
&#xD;
          -  male and female subjects&#xD;
&#xD;
          -  has neuropathic pain after traumatic spinal cord injury&#xD;
&#xD;
          -  has chronic pain, &gt;3 months&#xD;
&#xD;
          -  is stable on oral pain medications at least two weeks. (patients are allowed to&#xD;
             continue their pain medications, i.e., no change in pain medications.)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  currently adjusting oral pain medications for their neuropathic pain&#xD;
&#xD;
          -  have pain, but not neuropathic (e.g., from inflammation at the incision wound of the&#xD;
             residual limb or neuroma)&#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>No</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>
  <results_reference>
    <citation>Li S, Stampas A, Frontera J, Davis M, Li S. Combined transcranial direct current stimulation and breathing-controlled electrical stimulation for management of neuropathic pain after spinal cord injury. J Rehabil Med. 2018 Sep 28;50(9):814-820. doi: 10.2340/16501977-2379.</citation>
    <PMID>30132010</PMID>
  </results_reference>
  <verification_date>January 2019</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>December 17, 2018</results_first_submitted>
  <results_first_submitted_qc>January 16, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">January 24, 2019</results_first_posted>
  <last_update_submitted>January 16, 2019</last_update_submitted>
  <last_update_submitted_qc>January 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 24, 2019</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>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neuralgia</mesh_term>
  </condition_browse>
  <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 7, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/93/NCT03302793/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Sham tDCS and Then BreEStim; Then M1 tDCS and Then 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 Then BreEStim; Then Sham tDCS and Then 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="6"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>2 subjects only finished Combined active tDCS (M1) and BreEStim section, but didn't attend the Sham tDCS and BreEStim section.</population>
      <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="12"/>
          </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="12"/>
                  </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>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="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </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="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Pain as Assessed by Visual Analogue Scale (VAS)</title>
        <description>A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. To allow a continuous assessment of pain, VAS uses a 10 cm line labelled at '0' with 'no pain' and '10' with 'worst pain'. The line is marked at a point corresponding to the assessment of the pain.</description>
        <time_frame>baseline, 10 minutes after tDCS, 10 minutes after BreEstim</time_frame>
        <population>In the Sham tDCS and then BreEStim arm, only 10 participants were analyzed because 2 patients did not return for the second visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Sham tDCS and Then 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 Then 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>Pain as Assessed by Visual Analogue Scale (VAS)</title>
          <description>A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. To allow a continuous assessment of pain, VAS uses a 10 cm line labelled at '0' with 'no pain' and '10' with 'worst pain'. The line is marked at a point corresponding to the assessment of the pain.</description>
          <population>In the Sham tDCS and then BreEStim arm, only 10 participants were analyzed because 2 patients did not return for the second visit.</population>
          <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="10"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.0" spread="2.03"/>
                    <measurement group_id="O2" value="5.9" spread="1.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>After tDCS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.4" spread="2.26"/>
                    <measurement group_id="O2" value="5.3" spread="1.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>After BreEstim</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5" spread="1.91"/>
                    <measurement group_id="O2" value="3.1" spread="2.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Electrical Pain Threshold</title>
        <description>Trimmed surface electrodes (1 inch by 1 inch) were used to examine electrical pain thresholds upon application of electrical stimulation (electrical stimulator 7SA, Digitimer). To measure electrical pain threshold, a pair of electrodes was placed next to each other centered on the thenar eminence (which is a group of muscles on the palm of the human hand at the base of the thumb); the intensity of electrical stimulation was started from the sensation threshold level (determined in outcome measure 3) and increased in steps of 1 mA; and subjects were instructed to close their eyes and to say ''yes'' when they first felt electrical stimulation painful. The electrical pain threshold is the mA level at which a participant first felt electrical stimulation painful. To improve consistency among subjects, they were advised that the pain threshold level was equivalent to 1 on the 0-10 VAS scale. Three repetitions were made and the average was used as the electrical pain threshold.</description>
        <time_frame>baseline, 10 minutes after tDCS, 10 minutes after BreEstim</time_frame>
        <population>In the Sham tDCS and then BreEStim arm, only 10 participants were analyzed because 2 patients did not return for the second visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Sham tDCS and Then 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 Then 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</title>
          <description>Trimmed surface electrodes (1 inch by 1 inch) were used to examine electrical pain thresholds upon application of electrical stimulation (electrical stimulator 7SA, Digitimer). To measure electrical pain threshold, a pair of electrodes was placed next to each other centered on the thenar eminence (which is a group of muscles on the palm of the human hand at the base of the thumb); the intensity of electrical stimulation was started from the sensation threshold level (determined in outcome measure 3) and increased in steps of 1 mA; and subjects were instructed to close their eyes and to say ''yes'' when they first felt electrical stimulation painful. The electrical pain threshold is the mA level at which a participant first felt electrical stimulation painful. To improve consistency among subjects, they were advised that the pain threshold level was equivalent to 1 on the 0-10 VAS scale. Three repetitions were made and the average was used as the electrical pain threshold.</description>
          <population>In the Sham tDCS and then BreEStim arm, only 10 participants were analyzed because 2 patients did not return for the second visit.</population>
          <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="10"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.4" spread="25.53"/>
                    <measurement group_id="O2" value="35.0" spread="26.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>After tDCS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.1" spread="27.05"/>
                    <measurement group_id="O2" value="33.9" spread="26.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>After BreEstim</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.5" spread="24.14"/>
                    <measurement group_id="O2" value="35.2" spread="21.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Electrical Sensation Threshold</title>
        <description>Trimmed surface electrodes (1 inch by 1 inch) were used to examine electrical sensation threshold upon application of electrical stimulation (electrical stimulator 7SA, Digitimer). To measure electrical sensation threshold, a pair of electrodes was placed next to each other centered on the thenar eminence (which is a group of muscles on the palm of the human hand at the base of the thumb); the intensity of electrical stimulation was started from zero and gradually increased in steps of 0.1 mA; and subjects were instructed to close their eyes and to say ''yes'' when they explicitly felt electrical stimulation. The electrical sensation threshold is the mA level at which a participant explicitly felt electrical stimulation. Three repetitions were made and the average was used as the electrical sensation threshold.</description>
        <time_frame>baseline, 10 minutes after tDCS, 10 minutes after BreEstim</time_frame>
        <population>In the Sham tDCS and then BreEStim arm, only 10 participants were analyzed because 2 patients did not return for the second visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Sham tDCS and Then 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 Then 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</title>
          <description>Trimmed surface electrodes (1 inch by 1 inch) were used to examine electrical sensation threshold upon application of electrical stimulation (electrical stimulator 7SA, Digitimer). To measure electrical sensation threshold, a pair of electrodes was placed next to each other centered on the thenar eminence (which is a group of muscles on the palm of the human hand at the base of the thumb); the intensity of electrical stimulation was started from zero and gradually increased in steps of 0.1 mA; and subjects were instructed to close their eyes and to say ''yes'' when they explicitly felt electrical stimulation. The electrical sensation threshold is the mA level at which a participant explicitly felt electrical stimulation. Three repetitions were made and the average was used as the electrical sensation threshold.</description>
          <population>In the Sham tDCS and then BreEStim arm, only 10 participants were analyzed because 2 patients did not return for the second visit.</population>
          <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="10"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.3" spread="2.41"/>
                    <measurement group_id="O2" value="8.4" spread="2.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>After tDCS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.4" spread="2.84"/>
                    <measurement group_id="O2" value="8.1" spread="2.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>After BreEstim</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.3" spread="2.66"/>
                    <measurement group_id="O2" value="8.3" spread="2.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>16 hours after treatment</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Sham tDCS and Then 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 Then 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="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </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="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </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>
    <point_of_contact>
      <name_or_title>Dr. Sheng Li</name_or_title>
      <organization>UTHealth</organization>
      <phone>713-797-7125</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/NCT03302793
org study id: HSC-MS-14-0564 SCI
nct id: NCT03302793
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 spinal cord injury patients. Note that this study will also enroll
      healthy volunteers, 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: Pain as Assessed by Visual Analogue Scale (VAS)
time frame: baseline, 10 minutes after tDCS, 10 minutes after BreEstim
description: A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. To allow a continuous assessment of pain, VAS uses a 10 cm line labelled at '0' with 'no pain' and '10' with 'worst pain'. The line is marked at a point corresponding to the assessment of the pain.
measure: Electrical Pain Threshold
time frame: baseline, 10 minutes after tDCS, 10 minutes after BreEstim
description: Trimmed surface electrodes (1 inch by 1 inch) were used to examine electrical pain thresholds upon application of electrical stimulation (electrical stimulator 7SA, Digitimer). To measure electrical pain threshold, a pair of electrodes was placed next to each other centered on the thenar eminence (which is a group of muscles on the palm of the human hand at the base of the thumb); the intensity of electrical stimulation was started from the sensation threshold level (determined in outcome measure 3) and increased in steps of 1 mA; and subjects were instructed to close their eyes and to say ''yes'' when they first felt electrical stimulation painful. The electrical pain threshold is the mA level at which a participant first felt electrical stimulation painful. To improve consistency among subjects, they were advised that the pain threshold level was equivalent to 1 on the 0-10 VAS scale. Three repetitions were made and the average was used as the electrical pain threshold.
measure: Electrical Sensation Threshold
time frame: baseline, 10 minutes after tDCS, 10 minutes after BreEstim
description: Trimmed surface electrodes (1 inch by 1 inch) were used to examine electrical sensation threshold upon application of electrical stimulation (electrical stimulator 7SA, Digitimer). To measure electrical sensation threshold, a pair of electrodes was placed next to each other centered on the thenar eminence (which is a group of muscles on the palm of the human hand at the base of the thumb); the intensity of electrical stimulation was started from zero and gradually increased in steps of 0.1 mA; and subjects were instructed to close their eyes and to say ''yes'' when they explicitly felt electrical stimulation. The electrical sensation threshold is the mA level at which a participant explicitly felt electrical stimulation. Three repetitions were made and the average was used as the electrical sensation threshold.
arm group label: BreEStim and tDCS sham, then combined BreEStim and tDCS
arm group type: Experimental
description: BreEStim is voluntary breathing controlled electrical stimulation.
arm group label: Combined BreEStim and tDCS, then BreEStim and tDCS sham
arm group type: Experimental
description: BreEStim is voluntary breathing controlled electrical stimulation. tDCS is transcranial direct current stimulation.
intervention type: Device
intervention name: BreEStim
description: BreEStim will applied for 10 to 20 minutes.
arm group label: BreEStim and tDCS sham, then combined BreEStim and tDCS
arm group label: Combined BreEStim and tDCS, then BreEStim and tDCS sham
intervention type: Device
intervention name: tDCS
description: tDCS will be applied for 20 minutes.
arm group label: BreEStim and tDCS sham, then combined BreEStim and tDCS
arm group label: Combined BreEStim and tDCS, then BreEStim and tDCS sham
intervention type: Device
intervention name: tDCS sham
arm group label: BreEStim and tDCS sham, then combined BreEStim and tDCS
arm group label: Combined BreEStim and tDCS, then BreEStim and tDCS sham
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Sheng Li, MD, PhD
role: Principal Investigator
affiliation: The University of Texas Health Science Center, Houston
facility: 
country: United States
citation: Li S, Stampas A, Frontera J, Davis M, Li S. Combined transcranial direct current stimulation and breathing-controlled electrical stimulation for management of neuropathic pain after spinal cord injury. J Rehabil Med. 2018 Sep 28;50(9):814-820. doi: 10.2340/16501977-2379.
PMID: 30132010
responsible party type: Principal Investigator
investigator affiliation: The University of Texas Health Science Center, Houston
investigator full name: Sheng Li
investigator title: Associate Professor
mesh term: Neuralgia
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 