<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/NCT04506099</url>
  </required_header>
  <id_info>
    <org_study_id>HSC-MS-20-0048</org_study_id>
    <nct_id>NCT04506099</nct_id>
  </id_info>
  <brief_title>Transcutaneous Intercostal Nerve Stimulation in Spinal Cord Injury</brief_title>
  <acronym>TINS</acronym>
  <official_title>Transcutaneous Intercostal Nerve Stimulation in Spinal Cord Injury</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>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the safety, feasibility, and effectiveness of&#xD;
      electric stimulation of the nerves along the intercostal nerves on pain and spasticity in&#xD;
      spinal cord injury patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Neuromodulation techniques are safely used as a treatment for neuropathic pain in chronic&#xD;
      SCI. Neuromodulation techniques have also been safely and successfully used to strengthen the&#xD;
      abdomen in stroke patients.10 Most similar to our TINS protocol is transcutaneous tibial&#xD;
      nerve stimulation (TTNS), which has shown to mitigate the development of neurogenic bladder&#xD;
      in acute SCI.6 However, neuromodulation is rarely performed in acute SCI, and, to our&#xD;
      knowledge, neuromodulation has not been performed to prevent the development of chronic&#xD;
      neuropathic pain. There has been little published regarding the effects of electric&#xD;
      stimulation upon the trunk in acute SCI as a prevention for chronic neuropathic pain and&#xD;
      spasticity. Gaps in the knowledge which we intend to fill are:&#xD;
&#xD;
        1. Safety and feasibility of TINS in acute SCI during inpatient rehabilitation.&#xD;
&#xD;
        2. Effectiveness of a 2-week TINS protocol in acute SCI based on changes between admission,&#xD;
           discharge, and weekly numerical pain scores and spasticity questionnaire scores in those&#xD;
           with TINS compared to sham TINS for 2-months.&#xD;
&#xD;
        3. Analysis of neuropathic pain medication dosages in those with and without TINS at&#xD;
           admission, discharge, and 2 months post-discharge, and evaluation of morbidity at 2-&#xD;
           months post-discharge&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Lack of study staff&#xD;
  </why_stopped>
  <start_date type="Actual">July 17, 2020</start_date>
  <completion_date type="Anticipated">November 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Randomized sham-controlled trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>Study participants will be blinded to the stimulation parameters of the TINS. The research assistant/investigator will apply the electrodes and the PI will be blinded the stimulation setting as well. Unblinding is expected to occur after the 2 month follow up, at which point both subject and PI will be made aware of their group assignment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with morbidity as measured by infections</measure>
    <time_frame>Admission</time_frame>
    <description>Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking infections</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with morbidity as measured by infections</measure>
    <time_frame>4-weeks post injury</time_frame>
    <description>Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking infections.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with morbidity as measured by infections</measure>
    <time_frame>2-month follow-up</time_frame>
    <description>Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking infections.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with morbidity as measured by burns.</measure>
    <time_frame>Admission</time_frame>
    <description>Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking burns.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with morbidity as measured by burns.</measure>
    <time_frame>4-weeks post injury</time_frame>
    <description>Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking burns.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with morbidity as measured by burns.</measure>
    <time_frame>2-month follow-up</time_frame>
    <description>Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking burns.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with morbidity as measured by urgent transfers.</measure>
    <time_frame>Admission</time_frame>
    <description>Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking urgent transfers</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with morbidity as measured by urgent transfers.</measure>
    <time_frame>4-weeks post injury</time_frame>
    <description>Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking urgent transfers</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with morbidity as measured by urgent transfers.</measure>
    <time_frame>2-month follow up</time_frame>
    <description>Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking urgent transfers</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with morbidity as measured by spasticity scores per usual care.</measure>
    <time_frame>Admission</time_frame>
    <description>Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking spasticity scores recorded per usual care</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with morbidity as measured by spasticity scores per usual care.</measure>
    <time_frame>4-weeks post injury</time_frame>
    <description>Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking spasticity scores recorded per usual care</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with morbidity as measured by spasticity scores per usual care.</measure>
    <time_frame>2-month follow-up</time_frame>
    <description>Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking spasticity scores recorded per usual care</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with improved spasiticy scores as measured by PENN SPASM FREQUENCY SCALE (PSFS)</measure>
    <time_frame>Baseline</time_frame>
    <description>Contains clinically relevant core questions concerning SCI-related pain. This is a 2 component self-report measure of the frequency of reported muscle spasms which is commonly used to quantify spasticity. Developed to augment clinical ratings of spasticity and provide a more comprehensive understanding of an individual's spasticity status. The first component is a 5 point scale assessing the frequency with which spasms occur ranging from &quot;0 = No spasms&quot; to &quot;4 = Spontaneous spasms occurring more than ten times per hour&quot;. The second component is a 3 point scale assessing the severity of spasms ranging from &quot;1 = Mild&quot; to &quot;3 = Severe&quot;. The second component is not answered if the person indicates they have no spasms in part. Lower scores indicate better outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with improved spasiticy scores as measured by PENN SPASM FREQUENCY SCALE (PSFS)</measure>
    <time_frame>2-month follow-up</time_frame>
    <description>Contains clinically relevant core questions concerning SCI-related pain. This is a 2 component self-report measure of the frequency of reported muscle spasms which is commonly used to quantify spasticity. Developed to augment clinical ratings of spasticity and provide a more comprehensive understanding of an individual's spasticity status. The first component is a 5 point scale assessing the frequency with which spasms occur ranging from &quot;0 = No spasms&quot; to &quot;4 = Spontaneous spasms occurring more than ten times per hour&quot;. The second component is a 3 point scale assessing the severity of spasms ranging from &quot;1 = Mild&quot; to &quot;3 = Severe&quot;. The second component is not answered if the person indicates they have no spasms in part. Lower scores indicate better outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with decreased pain medication dosage compared at discharge and 2-month follow-up.</measure>
    <time_frame>4-weeks post injury</time_frame>
    <description>Compare number of participants with decreased pain medication dosage at discharge and 2-month follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with decreased pain medication dosage compared at discharge and 2-month follow-up.</measure>
    <time_frame>2-month follow-up</time_frame>
    <description>Compare number of participants with decreased pain medication dosage at discharge and 2-month follow-up.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Neuropathic Pain</condition>
  <condition>SCI - Spinal Cord Injury</condition>
  <arm_group>
    <arm_group_label>TINS Active</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Electrical stimulation will be applied to the T6-T11 levels of intercostal nerves, as close to the level directly below the level of injury as possible. For example, a T7 level of injury will have TINS applied to the T8 level. A T2 level of injury will have TINS applied to the T6 level. Electrodes 2 inch by 4 inch will be placed according to anatomic landmarks with the negative electrode applied to the lateral ribcage and the positive electrode applied to the ventral aspect, verified with contraction of the rectus abdominis. The intensity level will be set to the amperage immediately under the threshold for motor contraction. If there is no contraction seen, patients will be excluded. In addition, if the patient perceives pain, the intensity will be lowered until comfortable. Stimulation frequency of 20 Hz and pulse width of 200ms in continuous mode will be used.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham protocol</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Electrical stimulation will be applied to the T6-T11 levels of intercostal nerves, as close to the level directly below the level of injury as possible until contraction is seen in the rectus abdominis. Stimulation frequency of 20 Hz and pulse width of 200ms in continuous mode will be used. Electrodes 2 inch by 4 inch will be placed according to anatomic landmarks with the negative electrode applied to the lateral ribcage and the positive electrode applied to the ventral aspect. The intensity level will be set to 1mA . If there is no contraction seen, patients will be excluded. In addition, if the patient perceives pain, the intensity will be lowered until comfortable.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TINS Active protocol</intervention_name>
    <description>Electrical stimulation will be applied to the T6-T11 levels of intercostal nerves, as close to the level directly below the level of injury as possible. Electrodes 2 inch by 4 inch will be placed according to anatomic landmarks with the negative electrode applied to the lateral ribcage and the positive electrode applied to the ventral aspect, verified with contraction of the rectus abdominis. The intensity level will be set to the amperage immediately under the threshold for motor contraction. If there is no contraction seen, patients will be excluded. In addition, if the patient perceives pain, the intensity will be lowered until comfortable. Stimulation frequency of 20 Hz and pulse width of 200ms in continuous mode will be used.</description>
    <arm_group_label>TINS Active</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham protocol</intervention_name>
    <description>Electrical stimulation will be applied to the T6-T11 levels of intercostal nerves, as close to the level directly below the level of injury as possible until contraction is seen in the rectus abdominis. Stimulation frequency of 20 Hz and pulse width of 200ms in continuous mode will be used. Electrodes 2 inch by 4 inch will be placed according to anatomic landmarks with the negative electrode applied to the lateral ribcage and the positive electrode applied to the ventral aspect. The intensity level will be set to 1mA . If there is no contraction seen, patients will be excluded. In addition, if the patient perceives pain, the intensity will be lowered until comfortable.</description>
    <arm_group_label>Sham protocol</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Acute tSCI paraplegia within 4 weeks of injury (n=22)&#xD;
&#xD;
          -  18-75 years old&#xD;
&#xD;
          -  Neurologic levels T1-T10&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  Admitted to TIRR with pain medications&#xD;
&#xD;
          -  TINS can elicit visible or palpable abdominal muscle contraction&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with pacemakers, defibrillators, insulin pumps, and similar devices&#xD;
&#xD;
          -  History of peripheral neuropathy&#xD;
&#xD;
          -  History of premorbid symptoms of peripheral neuropathy (numbness and/or tingling in&#xD;
             the lower extremities, sharp/jabbing/burning pain in the lower extremities,&#xD;
             sensitivity to touch, lack of coordination, lack of sensation, muscle weakness, etc.)&#xD;
&#xD;
          -  History of nervous system disorder (i.e. prior SCI, stroke, brain injury, degenerative&#xD;
             diseases such as Parkinson's disease, etc.)&#xD;
&#xD;
          -  Ventilator dependent respiration&#xD;
&#xD;
          -  Inability to speak&#xD;
&#xD;
          -  Non-English speakers&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  History of chronic pain&#xD;
&#xD;
          -  Intolerant to electric stimulation&#xD;
&#xD;
          -  Intolerant to the trial sessions&#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>Argyrios Stampas, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UTHealth</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The University of Texas Health Science Center at Houston</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>
  <reference>
    <citation>Ackery A, Tator C, Krassioukov A. A global perspective on spinal cord injury epidemiology. J Neurotrauma. 2004 Oct;21(10):1355-70. doi: 10.1089/neu.2004.21.1355.</citation>
    <PMID>15672627</PMID>
  </reference>
  <reference>
    <citation>McNeill DL, Carlton SM, Hulsebosch CE. Intraspinal sprouting of calcitonin gene-related peptide containing primary afferents after deafferentation in the rat. Exp Neurol. 1991 Dec;114(3):321-9. doi: 10.1016/0014-4886(91)90158-9.</citation>
    <PMID>1748206</PMID>
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    <citation>McNeill DL, Hulsebosch CE. Intraspinal sprouting of rat primary afferents after deafferentation. Neurosci Lett. 1987 Oct 16;81(1-2):57-62. doi: 10.1016/0304-3940(87)90340-5.</citation>
    <PMID>3696474</PMID>
  </reference>
  <reference>
    <citation>Diamond J, Foerster A. Recovery of sensory function in skin deprived of its innervation by lesion of the peripheral nerve. Exp Neurol. 1992 Jan;115(1):100-3. doi: 10.1016/0014-4886(92)90229-j. No abstract available.</citation>
    <PMID>1728554</PMID>
  </reference>
  <reference>
    <citation>Gwak YS, Hulsebosch CE. Neuronal hyperexcitability: a substrate for central neuropathic pain after spinal cord injury. Curr Pain Headache Rep. 2011 Jun;15(3):215-22. doi: 10.1007/s11916-011-0186-2.</citation>
    <PMID>21387163</PMID>
  </reference>
  <reference>
    <citation>Stampas A, Korupolu R, Zhu L, Smith CP, Gustafson K. Safety, Feasibility, and Efficacy of Transcutaneous Tibial Nerve Stimulation in Acute Spinal Cord Injury Neurogenic Bladder: A Randomized Control Pilot Trial. Neuromodulation. 2019 Aug;22(6):716-722. doi: 10.1111/ner.12855. Epub 2018 Oct 3.</citation>
    <PMID>30284350</PMID>
  </reference>
  <reference>
    <citation>Hatch MN, Cushing TR, Carlson GD, Chang EY. Neuropathic pain and SCI: Identification and treatment strategies in the 21st century. J Neurol Sci. 2018 Jan 15;384:75-83. doi: 10.1016/j.jns.2017.11.018. Epub 2017 Nov 16.</citation>
    <PMID>29249383</PMID>
  </reference>
  <reference>
    <citation>Ataoglu E, Tiftik T, Kara M, Tunc H, Ersoz M, Akkus S. Effects of chronic pain on quality of life and depression in patients with spinal cord injury. Spinal Cord. 2013 Jan;51(1):23-6. doi: 10.1038/sc.2012.51. Epub 2012 May 1.</citation>
    <PMID>22547044</PMID>
  </reference>
  <reference>
    <citation>Johnson MI, Bjordal JM. Transcutaneous electrical nerve stimulation for the management of painful conditions: focus on neuropathic pain. Expert Rev Neurother. 2011 May;11(5):735-53. doi: 10.1586/ern.11.48.</citation>
    <PMID>21539490</PMID>
  </reference>
  <reference>
    <citation>Ko EJ, Chun MH, Kim DY, Yi JH, Kim W, Hong J. The Additive Effects of Core Muscle Strengthening and Trunk NMES on Trunk Balance in Stroke Patients. Ann Rehabil Med. 2016 Feb;40(1):142-51. doi: 10.5535/arm.2016.40.1.142. Epub 2016 Feb 26.</citation>
    <PMID>26949681</PMID>
  </reference>
  <reference>
    <citation>Nichols ME, Meador KJ, Loring DW, Poon LW, Clayton GM, Martin P. Age-related changes in the neurologic examination of healthy sexagenarians, octogenarians, and centenarians. J Geriatr Psychiatry Neurol. 1994 Jan-Mar;7(1):1-7. doi: 10.1177/089198879400700101.</citation>
    <PMID>8192823</PMID>
  </reference>
  <reference>
    <citation>https://www.nscisc.uab.edu/Public/Facts%202015.pdf</citation>
  </reference>
  <reference>
    <citation>Dubeau CE. The aging lower urinary tract. J Urol. 2006 Mar;175(3 Pt 2):S11-5. doi: 10.1016/S0022-5347(05)00311-3.</citation>
    <PMID>16458733</PMID>
  </reference>
  <reference>
    <citation>http://www.emsci.org/index.php/project/the-project/time-schedule</citation>
  </reference>
  <reference>
    <citation>Chartier-Kastler EJ, Denys P, Chancellor MB, Haertig A, Bussel B, Richard F. Urodynamic monitoring during percutaneous sacral nerve neurostimulation in patients with neurogenic detrusor hyperreflexia. Neurourol Urodyn. 2001;20(1):61-71. doi: 10.1002/1520-6777(2001)20:13.0.co;2-d.</citation>
    <PMID>11135383</PMID>
  </reference>
  <reference>
    <citation>Bellucci CH, Wollner J, Gregorini F, Birnbock D, Kozomara M, Mehnert U, Schubert M, Kessler TM. Acute spinal cord injury--do ambulatory patients need urodynamic investigations? J Urol. 2013 Apr;189(4):1369-73. doi: 10.1016/j.juro.2012.10.013. Epub 2012 Oct 12.</citation>
    <PMID>23069382</PMID>
  </reference>
  <reference>
    <citation>Buchele G, Och B, Bolte G, Weiland SK. Single vs. double data entry. Epidemiology. 2005 Jan;16(1):130-1. doi: 10.1097/01.ede.0000147166.24478.f4. No abstract available.</citation>
    <PMID>15613958</PMID>
  </reference>
  <reference>
    <citation>Verrills P, Vivian D, Mitchell B, Barnard A. Peripheral nerve field stimulation for chronic pain: 100 cases and review of the literature. Pain Med. 2011 Sep;12(9):1395-405. doi: 10.1111/j.1526-4637.2011.01201.x. Epub 2011 Aug 3.</citation>
    <PMID>21812906</PMID>
  </reference>
  <reference>
    <citation>Petersen EA, Slavin KV. Peripheral nerve/field stimulation for chronic pain. Neurosurg Clin N Am. 2014 Oct;25(4):789-97. doi: 10.1016/j.nec.2014.07.003. Epub 2014 Aug 15.</citation>
    <PMID>25240665</PMID>
  </reference>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>October 15, 2021</last_update_submitted>
  <last_update_submitted_qc>October 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 22, 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>Argyrios Stampas, MD</investigator_full_name>
    <investigator_title>Spinal Cord Injury Medicine Research Director</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Injuries</mesh_term>
    <mesh_term>Neuralgia</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04506099
org study id: HSC-MS-20-0048
nct id: NCT04506099
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The purpose of this study is to determine the safety, feasibility, and effectiveness of
      electric stimulation of the nerves along the intercostal nerves on pain and spasticity in
      spinal cord injury patients.
Neuromodulation techniques are safely used as a treatment for neuropathic pain in chronic
      SCI. Neuromodulation techniques have also been safely and successfully used to strengthen the
      abdomen in stroke patients.10 Most similar to our TINS protocol is transcutaneous tibial
      nerve stimulation (TTNS), which has shown to mitigate the development of neurogenic bladder
      in acute SCI.6 However, neuromodulation is rarely performed in acute SCI, and, to our
      knowledge, neuromodulation has not been performed to prevent the development of chronic
      neuropathic pain. There has been little published regarding the effects of electric
      stimulation upon the trunk in acute SCI as a prevention for chronic neuropathic pain and
      spasticity. Gaps in the knowledge which we intend to fill are:

        1. Safety and feasibility of TINS in acute SCI during inpatient rehabilitation.

        2. Effectiveness of a 2-week TINS protocol in acute SCI based on changes between admission,
           discharge, and weekly numerical pain scores and spasticity questionnaire scores in those
           with TINS compared to sham TINS for 2-months.

        3. Analysis of neuropathic pain medication dosages in those with and without TINS at
           admission, discharge, and 2 months post-discharge, and evaluation of morbidity at 2-
           months post-discharge
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized sham-controlled trial
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: Study participants will be blinded to the stimulation parameters of the TINS. The research assistant/investigator will apply the electrodes and the PI will be blinded the stimulation setting as well. Unblinding is expected to occur after the 2 month follow up, at which point both subject and PI will be made aware of their group assignment.
measure: Number of participants with morbidity as measured by infections
time frame: Admission
description: Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking infections
measure: Number of participants with morbidity as measured by infections
time frame: 4-weeks post injury
description: Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking infections.
measure: Number of participants with morbidity as measured by infections
time frame: 2-month follow-up
description: Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking infections.
measure: Number of participants with morbidity as measured by burns.
time frame: Admission
description: Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking burns.
measure: Number of participants with morbidity as measured by burns.
time frame: 4-weeks post injury
description: Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking burns.
measure: Number of participants with morbidity as measured by burns.
time frame: 2-month follow-up
description: Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking burns.
measure: Number of participants with morbidity as measured by urgent transfers.
time frame: Admission
description: Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking urgent transfers
measure: Number of participants with morbidity as measured by urgent transfers.
time frame: 4-weeks post injury
description: Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking urgent transfers
measure: Number of participants with morbidity as measured by urgent transfers.
time frame: 2-month follow up
description: Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking urgent transfers
measure: Number of participants with morbidity as measured by spasticity scores per usual care.
time frame: Admission
description: Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking spasticity scores recorded per usual care
measure: Number of participants with morbidity as measured by spasticity scores per usual care.
time frame: 4-weeks post injury
description: Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking spasticity scores recorded per usual care
measure: Number of participants with morbidity as measured by spasticity scores per usual care.
time frame: 2-month follow-up
description: Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking spasticity scores recorded per usual care
measure: Number of participants with improved spasiticy scores as measured by PENN SPASM FREQUENCY SCALE (PSFS)
time frame: Baseline
description: Contains clinically relevant core questions concerning SCI-related pain. This is a 2 component self-report measure of the frequency of reported muscle spasms which is commonly used to quantify spasticity. Developed to augment clinical ratings of spasticity and provide a more comprehensive understanding of an individual's spasticity status. The first component is a 5 point scale assessing the frequency with which spasms occur ranging from "0 = No spasms" to "4 = Spontaneous spasms occurring more than ten times per hour". The second component is a 3 point scale assessing the severity of spasms ranging from "1 = Mild" to "3 = Severe". The second component is not answered if the person indicates they have no spasms in part. Lower scores indicate better outcomes.
measure: Number of participants with improved spasiticy scores as measured by PENN SPASM FREQUENCY SCALE (PSFS)
time frame: 2-month follow-up
description: Contains clinically relevant core questions concerning SCI-related pain. This is a 2 component self-report measure of the frequency of reported muscle spasms which is commonly used to quantify spasticity. Developed to augment clinical ratings of spasticity and provide a more comprehensive understanding of an individual's spasticity status. The first component is a 5 point scale assessing the frequency with which spasms occur ranging from "0 = No spasms" to "4 = Spontaneous spasms occurring more than ten times per hour". The second component is a 3 point scale assessing the severity of spasms ranging from "1 = Mild" to "3 = Severe". The second component is not answered if the person indicates they have no spasms in part. Lower scores indicate better outcomes.
measure: Number of participants with decreased pain medication dosage compared at discharge and 2-month follow-up.
time frame: 4-weeks post injury
description: Compare number of participants with decreased pain medication dosage at discharge and 2-month follow-up.
measure: Number of participants with decreased pain medication dosage compared at discharge and 2-month follow-up.
time frame: 2-month follow-up
description: Compare number of participants with decreased pain medication dosage at discharge and 2-month follow-up.
arm group label: TINS Active
arm group type: Active Comparator
description: Electrical stimulation will be applied to the T6-T11 levels of intercostal nerves, as close to the level directly below the level of injury as possible. For example, a T7 level of injury will have TINS applied to the T8 level. A T2 level of injury will have TINS applied to the T6 level. Electrodes 2 inch by 4 inch will be placed according to anatomic landmarks with the negative electrode applied to the lateral ribcage and the positive electrode applied to the ventral aspect, verified with contraction of the rectus abdominis. The intensity level will be set to the amperage immediately under the threshold for motor contraction. If there is no contraction seen, patients will be excluded. In addition, if the patient perceives pain, the intensity will be lowered until comfortable. Stimulation frequency of 20 Hz and pulse width of 200ms in continuous mode will be used.
arm group label: Sham protocol
arm group type: Sham Comparator
description: Electrical stimulation will be applied to the T6-T11 levels of intercostal nerves, as close to the level directly below the level of injury as possible until contraction is seen in the rectus abdominis. Stimulation frequency of 20 Hz and pulse width of 200ms in continuous mode will be used. Electrodes 2 inch by 4 inch will be placed according to anatomic landmarks with the negative electrode applied to the lateral ribcage and the positive electrode applied to the ventral aspect. The intensity level will be set to 1mA . If there is no contraction seen, patients will be excluded. In addition, if the patient perceives pain, the intensity will be lowered until comfortable.
intervention type: Device
intervention name: TINS Active protocol
description: Electrical stimulation will be applied to the T6-T11 levels of intercostal nerves, as close to the level directly below the level of injury as possible. Electrodes 2 inch by 4 inch will be placed according to anatomic landmarks with the negative electrode applied to the lateral ribcage and the positive electrode applied to the ventral aspect, verified with contraction of the rectus abdominis. The intensity level will be set to the amperage immediately under the threshold for motor contraction. If there is no contraction seen, patients will be excluded. In addition, if the patient perceives pain, the intensity will be lowered until comfortable. Stimulation frequency of 20 Hz and pulse width of 200ms in continuous mode will be used.
arm group label: TINS Active
intervention type: Device
intervention name: Sham protocol
description: Electrical stimulation will be applied to the T6-T11 levels of intercostal nerves, as close to the level directly below the level of injury as possible until contraction is seen in the rectus abdominis. Stimulation frequency of 20 Hz and pulse width of 200ms in continuous mode will be used. Electrodes 2 inch by 4 inch will be placed according to anatomic landmarks with the negative electrode applied to the lateral ribcage and the positive electrode applied to the ventral aspect. The intensity level will be set to 1mA . If there is no contraction seen, patients will be excluded. In addition, if the patient perceives pain, the intensity will be lowered until comfortable.
arm group label: Sham protocol
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Argyrios Stampas, MD
role: Principal Investigator
affiliation: UTHealth
facility: 
country: United States
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responsible party type: Principal Investigator
investigator affiliation: The University of Texas Health Science Center, Houston
investigator full name: Argyrios Stampas, MD
investigator title: Spinal Cord Injury Medicine Research Director
mesh term: Spinal Cord Injuries
mesh term: Neuralgia
mesh term: Wounds and Injuries
sharing ipd: No