<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/NCT03764514</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00076097</org_study_id>
    <nct_id>NCT03764514</nct_id>
  </id_info>
  <brief_title>Spinal Cord Stimulation in Chemotherapy Induced Neuropathy</brief_title>
  <official_title>Effectiveness of Spinal Cord Stimulation as Therapy for Chemotherapy-Induced Peripheral Neuropathy: A Pilot Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prisma Health-Upstate</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Prisma Health-Upstate</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an observational based pilot study evaluating the use of spinal cord stimulators for&#xD;
      the treatment of chemotherapy induced peripheral neuropathy will lead to an increase in&#xD;
      quality of life and decrease in pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cancer treatment, for many patients, results in painful side effects. As evidence mounts&#xD;
      demonstrating the risks associated with long term opioid therapy, non-opioid modalities need&#xD;
      to be developed. Spinal cord stimulators are implanted devices that modulate the pain&#xD;
      signaling system in the spinal cord. This research hopes to determine if the use of a spinal&#xD;
      cord stimulator in patients with chemotherapy induced peripheral neuropathy will lead to an&#xD;
      increase in quality of life and decrease in pain.The primary endpoints will be the number of&#xD;
      patients who undergo permanent implantation. The endpoints will measure pain with the Brief&#xD;
      Pain Inventory Short Form visual analog scale. The sleep quality will be measured using the&#xD;
      Pittsburgh Sleep Quality Assessment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 3, 2018</start_date>
  <completion_date type="Actual">May 3, 2022</completion_date>
  <primary_completion_date type="Actual">May 3, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Permanent Spinal Cord Stimulator Implantation</measure>
    <time_frame>2 years</time_frame>
    <description>To determine the total number of patients who undergo permanent spinal cord stimulator implantation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subjective Pain Assessment: Brief Pain Inventory-Short Form</measure>
    <time_frame>2 years</time_frame>
    <description>Measure Pain with the Brief Pain Inventory-Short Form. The scale measures the severity of pain and the impact of pain on daily functions. The scale range includes 0-10 scales, with 0=no interference and 10=interferes completely. There is not a scoring algorithm, but &quot;worst pain&quot; or the average of the four severity items can be used as measures of pain severity; the average of the seven interference items can be used as a measure of pain interference.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Quality of Life Assessment: Pittsburgh Sleep Quality Assessment</measure>
    <time_frame>2 years</time_frame>
    <description>Measure quality of life through the use of the Pittsburgh Sleep Quality Assessment. The Pittsburgh Sleep Quality Index is a 19-item, self-rated questionnaire designed to measure sleep quality and disturbance over the past month in clinical populations.The 19 items are grouped into 7 components, including (1) sleep duration, (2) sleep disturbance, (3) sleep latency, (4) daytime dysfunction due to sleepiness, (5) sleep efficiency, (6) overall sleep quality, and (7) sleep medication use. Each of the sleep components yields a score ranging from 0 to 3, with 3 indicating the greatest dysfunction. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (global score) indicating worse sleep quality.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">5</enrollment>
  <condition>Chemotherapy-induced Peripheral Neuropathy</condition>
  <arm_group>
    <arm_group_label>Spinal Cord Stimulator - Permanent Implantation</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Spinal Cord Stimulator</intervention_name>
    <description>Permanent Implantation</description>
    <arm_group_label>Spinal Cord Stimulator - Permanent Implantation</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Primary Care Clinic&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        • The patient has persistent, severe peripheral neuropathy secondary to chemotherapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Refusal to undergo a spinal cord stimulator procedure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joshua Smith, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Prisma Health-Upstate</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Patewood Memorial Hospital</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29615</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Braun Filho JL, Braun LM. [Spinal cord stimulation in the treatment of refractory painful polineuropathy induced by chemotherapy.]. Rev Bras Anestesiol. 2007 Oct;57(5):533-8. doi: 10.1590/s0034-70942007000500008. Portuguese.</citation>
    <PMID>19462129</PMID>
  </reference>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>March 27, 2023</last_update_submitted>
  <last_update_submitted_qc>March 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peripheral Nervous System Diseases</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/NCT03764514
org study id: Pro00076097
nct id: NCT03764514
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
This is an observational based pilot study evaluating the use of spinal cord stimulators for
      the treatment of chemotherapy induced peripheral neuropathy will lead to an increase in
      quality of life and decrease in pain.
Cancer treatment, for many patients, results in painful side effects. As evidence mounts
      demonstrating the risks associated with long term opioid therapy, non-opioid modalities need
      to be developed. Spinal cord stimulators are implanted devices that modulate the pain
      signaling system in the spinal cord. This research hopes to determine if the use of a spinal
      cord stimulator in patients with chemotherapy induced peripheral neuropathy will lead to an
      increase in quality of life and decrease in pain.The primary endpoints will be the number of
      patients who undergo permanent implantation. The endpoints will measure pain with the Brief
      Pain Inventory Short Form visual analog scale. The sleep quality will be measured using the
      Pittsburgh Sleep Quality Assessment.
observational model: Cohort
time perspective: Prospective
measure: Permanent Spinal Cord Stimulator Implantation
time frame: 2 years
description: To determine the total number of patients who undergo permanent spinal cord stimulator implantation.
measure: Subjective Pain Assessment: Brief Pain Inventory-Short Form
time frame: 2 years
description: Measure Pain with the Brief Pain Inventory-Short Form. The scale measures the severity of pain and the impact of pain on daily functions. The scale range includes 0-10 scales, with 0=no interference and 10=interferes completely. There is not a scoring algorithm, but "worst pain" or the average of the four severity items can be used as measures of pain severity; the average of the seven interference items can be used as a measure of pain interference.
measure: Subjective Quality of Life Assessment: Pittsburgh Sleep Quality Assessment
time frame: 2 years
description: Measure quality of life through the use of the Pittsburgh Sleep Quality Assessment. The Pittsburgh Sleep Quality Index is a 19-item, self-rated questionnaire designed to measure sleep quality and disturbance over the past month in clinical populations.The 19 items are grouped into 7 components, including (1) sleep duration, (2) sleep disturbance, (3) sleep latency, (4) daytime dysfunction due to sleepiness, (5) sleep efficiency, (6) overall sleep quality, and (7) sleep medication use. Each of the sleep components yields a score ranging from 0 to 3, with 3 indicating the greatest dysfunction. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (global score) indicating worse sleep quality.
arm group label: Spinal Cord Stimulator - Permanent Implantation
intervention type: Device
intervention name: Spinal Cord Stimulator
description: Permanent Implantation
arm group label: Spinal Cord Stimulator - Permanent Implantation
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Joshua Smith, MD
role: Principal Investigator
affiliation: Prisma Health-Upstate
facility: 
country: United States
citation: Braun Filho JL, Braun LM. [Spinal cord stimulation in the treatment of refractory painful polineuropathy induced by chemotherapy.]. Rev Bras Anestesiol. 2007 Oct;57(5):533-8. doi: 10.1590/s0034-70942007000500008. Portuguese.
PMID: 19462129
responsible party type: Sponsor
mesh term: Peripheral Nervous System Diseases
sharing ipd: No