xml: <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/NCT05968664</url>
    </required_header>
    <id_info>
      <org_study_id>H-49405</org_study_id>
      <nct_id>NCT05968664</nct_id>
    </id_info>
    <brief_title>Novel Stimulation Patterns to Improve the Effectiveness of Spinal Cord Stimulation</brief_title>
    <official_title>Novel Stimulation Patterns to Improve the Effectiveness of Spinal Cord Stimulation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ashwin Viswanathan</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Boston Scientific Corporation</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Baylor College of Medicine</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this study is to compare pain outcomes achieved by spinal cord stimulation (SCS)&#xD;
        using time varying stimulation patterns with pain outcomes achieved by current standard of&#xD;
        care SCS.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The researchers will conduct a traditional exploratory feasibility study using an&#xD;
        investigational device to compare the clinical outcomes using time varying pulse (TVP)&#xD;
        waveforms against time-invariant pulse (TIP) waveforms using both paresthesia and&#xD;
        paresthesia-free SCS therapies. The therapy longevity of TVPs and TIPS will also be evaluated&#xD;
        by tracking therapy efficacy through a long-term follow-up phase, using multiple pain&#xD;
        assessments and at-home digital data collection.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 2024</start_date>
    <completion_date type="Anticipated">January 2028</completion_date>
    <primary_completion_date type="Anticipated">January 2028</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>Triple (Participant, Care Provider, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Patient responder rate</measure>
      <time_frame>Patient responder rate will be measured from the baseline and during three experimental stimulation periods which are 8±3 weeks each.</time_frame>
      <description>The primary endpoint for this trial will be a comparison of the percentage of patients achieving at least a 50% reduction in pain during the TIP stimulation block with the percentage of patients achieving at least a 50% reduction in pain during either TVP stimulation block.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">43</enrollment>
    <condition>Chronic Pain</condition>
    <condition>Pain, Neuropathic</condition>
    <condition>Neuropathic Pain</condition>
    <arm_group>
      <arm_group_label>Time Invariant Pulse(TIP) Stimulation</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The control arm for this study will be the Time Invariant Pulse stimulation which is used in standard of care Spinal Cord Stimulation therapy. TIP tonic stimulation is delivered with fixed amplitude, pulse width, and frequency parameters.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Time Variant Pulse (TVP) Stimulation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The time variant pulse (TVP) stimulation will serve as the experimental arm for this study. There are two ways of delivering TVP stimulation to the spinal cord. TVP stimulation can either vary in intensity or it can vary rate, referred to as intensity-modulated TVP or rate-modulated TVP, respectively.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Spinal Cord Stimulator</intervention_name>
      <description>Spinal Cord Stimulator modified to deliver Time Variant Pulse (TVP) stimulation.</description>
      <arm_group_label>Time Variant Pulse (TVP) Stimulation</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Spinal Cord Stimulator</intervention_name>
      <description>Spinal Cord Stimulator to deliver standard of care Time Invariant Pulse (TIP) stimulation.</description>
      <arm_group_label>Time Invariant Pulse(TIP) Stimulation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Ability to provide informed consent&#xD;
  &#xD;
            -  Age ≥ 22&#xD;
  &#xD;
            -  Chronic pain of the trunk and/or limbs for at least 6 months&#xD;
  &#xD;
            -  Baseline average daily overall pain score of &gt;6 on the Numerical Rating Scale&#xD;
               collected with a 7-day pain diary related to pain of the trunk and/or limbs&#xD;
  &#xD;
            -  Failed &gt;3 medically supervised treatments (i.e. pain medications, physical therapy,&#xD;
               facet joint/medial branch nerve blocks, acupuncture), and treatment with &gt;2 classes of&#xD;
               medications&#xD;
  &#xD;
            -  Stable pain-related medication regimen 4 weeks prior to the trial. No new pain&#xD;
               medication will be added during the study period&#xD;
  &#xD;
            -  No back surgery within 6 months prior to Screening&#xD;
  &#xD;
            -  Consumed an average total daily morphine equivalent of ≤200 mg during the 30 days&#xD;
               prior to Screening.&#xD;
  &#xD;
            -  Baseline Oswestry Disability Index score ≥40 and ≤80&#xD;
  &#xD;
            -  Eligible candidate for SCS from a psychological and psychiatric standpoint as&#xD;
               determined within 180 days prior to Baseline Visit, per site's routine screening&#xD;
               process&#xD;
  &#xD;
            -  Able to independently read and complete all questionnaires and assessments provided in&#xD;
               English&#xD;
  &#xD;
            -  Female candidates of child-bearing potential agree to use contraception during the&#xD;
               study period&#xD;
  &#xD;
            -  Deemed to be a good candidate for spinal cord stimulation by the PI, and a board&#xD;
               certified pain management physician&#xD;
  &#xD;
            -  Willing to cooperate with study requirements&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patient exhibits catastrophization based on physician evaluation (e.g., average&#xD;
               overall daily pain intensity of 10 on a 0-10 numerical rating scale, every day during&#xD;
               the 7 days prior to Screening, based on patient recall)&#xD;
  &#xD;
            -  Pain originating from peripheral vascular disease&#xD;
  &#xD;
            -  Active treatment for cancer in past 6 months&#xD;
  &#xD;
            -  Involved in disability litigation&#xD;
  &#xD;
            -  High surgical risk including documented history of allergic response to titanium or&#xD;
               silicone, current systemic infection, or local infection in close proximity to&#xD;
               anticipated surgical field&#xD;
  &#xD;
            -  Body mass index ≥ 45 at Screening&#xD;
  &#xD;
            -  Terminal illness with anticipated survival &lt; 12 months&#xD;
  &#xD;
            -  Participant is immunocompromised&#xD;
  &#xD;
            -  Significant cognitive impairment at Screening that, in the opinion of the&#xD;
               Investigator, would reasonably be expected to impair the study candidate's ability to&#xD;
               participate in the study&#xD;
  &#xD;
            -  Participating (or intends to participate) in another drug or device clinical trial&#xD;
               that may influence the data that will be collected for this study&#xD;
  &#xD;
            -  Previous spinal cord stimulation trial/implant or is already implanted with an active&#xD;
               implantable device(s) (e.g. drug pump, implantable pulse generator)&#xD;
  &#xD;
            -  A pregnant female or a female of childbearing potential planning to get pregnant&#xD;
               during the course of the study&#xD;
  &#xD;
            -  Plan to receive any massage or manipulation directly over the leads or by the&#xD;
               anticipated location of the IPG or treatments that involve sudden jerking motions of&#xD;
               the torso at any&#xD;
  &#xD;
            -  Existing medical condition that is likely to require the use of diathermy&#xD;
  &#xD;
            -  Any injury or medical/psychological condition that might be significantly exacerbated&#xD;
               by the implant surgery or the presence of an implantable stimulator or otherwise&#xD;
               compromise subject safety&#xD;
  &#xD;
            -  Unable to operate the study devices including wrist-worn biosensor and mobile app&#xD;
  &#xD;
            -  Documented history of substance abuse or dependency in the 6 months prior to baseline&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>22 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ashwin Viswanathan, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Baylor College of Medicine</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ashwin Viswanathan, MD</last_name>
      <phone>7132138181</phone>
      <email>ashwinv@bcm.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Luke Jan Gelvoligaya, MA</last_name>
      <phone>7137987245</phone>
      <email>lukejan.gelvoligaya@bcm.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Baylor College of Medicine</name>
        <address>
          <city>Houston</city>
          <state>Texas</state>
          <zip>77030</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Aswhin Viswanathan, MD</last_name>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 7, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Baylor College of Medicine</investigator_affiliation>
      <investigator_full_name>Ashwin Viswanathan</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Chronic pain</keyword>
    <keyword>Spinal Cord Stimulation</keyword>
    <keyword>Spinal cord</keyword>
    <keyword>Neuropathy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neuralgia</mesh_term>
      <mesh_term>Chronic Pain</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05968664
  org study id: H-49405
  nct id: NCT05968664
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  The goal of this study is to compare pain outcomes achieved by spinal cord stimulation (SCS)
        using time varying stimulation patterns with pain outcomes achieved by current standard of
        care SCS.
  The researchers will conduct a traditional exploratory feasibility study using an
        investigational device to compare the clinical outcomes using time varying pulse (TVP)
        waveforms against time-invariant pulse (TIP) waveforms using both paresthesia and
        paresthesia-free SCS therapies. The therapy longevity of TVPs and TIPS will also be evaluated
        by tracking therapy efficacy through a long-term follow-up phase, using multiple pain
        assessments and at-home digital data collection.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Care Provider, Investigator)
  measure: Change in Patient responder rate
  time frame: Patient responder rate will be measured from the baseline and during three experimental stimulation periods which are 8±3 weeks each.
  description: The primary endpoint for this trial will be a comparison of the percentage of patients achieving at least a 50% reduction in pain during the TIP stimulation block with the percentage of patients achieving at least a 50% reduction in pain during either TVP stimulation block.
  arm group label: Time Invariant Pulse(TIP) Stimulation
  arm group type: Active Comparator
  description: The control arm for this study will be the Time Invariant Pulse stimulation which is used in standard of care Spinal Cord Stimulation therapy. TIP tonic stimulation is delivered with fixed amplitude, pulse width, and frequency parameters.
  arm group label: Time Variant Pulse (TVP) Stimulation
  arm group type: Experimental
  description: The time variant pulse (TVP) stimulation will serve as the experimental arm for this study. There are two ways of delivering TVP stimulation to the spinal cord. TVP stimulation can either vary in intensity or it can vary rate, referred to as intensity-modulated TVP or rate-modulated TVP, respectively.
  intervention type: Device
  intervention name: Spinal Cord Stimulator
  description: Spinal Cord Stimulator modified to deliver Time Variant Pulse (TVP) stimulation.
  arm group label: Time Variant Pulse (TVP) Stimulation
  intervention type: Device
  intervention name: Spinal Cord Stimulator
  description: Spinal Cord Stimulator to deliver standard of care Time Invariant Pulse (TIP) stimulation.
  arm group label: Time Invariant Pulse(TIP) Stimulation
  criteria: 
  gender: All
  minimum age: 22 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Ashwin Viswanathan, MD
  role: Principal Investigator
  affiliation: Baylor College of Medicine
  last name: Ashwin Viswanathan, MD
  phone: 7132138181
  email: ashwinv@bcm.edu
  last name: Luke Jan Gelvoligaya, MA
  phone: 7137987245
  email: lukejan.gelvoligaya@bcm.edu
  facility: 
  contact: 
  country: United States
  responsible party type: Sponsor-Investigator
  investigator affiliation: Baylor College of Medicine
  investigator full name: Ashwin Viswanathan
  investigator title: Professor
  mesh term: Neuralgia
  mesh term: Chronic Pain
  sharing ipd: Yes
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd info type: Analytic Code