<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/NCT03768791</url>
  </required_header>
  <id_info>
    <org_study_id>SYNCHRO</org_study_id>
    <nct_id>NCT03768791</nct_id>
  </id_info>
  <brief_title>HRV in Patients Treated With Spinal Cord Stimulation</brief_title>
  <official_title>Heart Rate Variability in Patients With Failed Back Surgery Syndrome, Treated With Spinal Cord Stimulation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Moens Maarten</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitair Ziekenhuis Brussel</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is an observatory single center study investigating heart rate variability during&#xD;
      on and off states of the spinal cord stimulator, in patients with failed back surgery&#xD;
      syndrome.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Actual">December 21, 2018</completion_date>
  <primary_completion_date type="Actual">December 21, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Heart rate variability changes</measure>
    <time_frame>Two times on the same day; once while SCS is switched off and once while SCS is switched on. Total study duration lasts one day.</time_frame>
    <description>The investigators will examine the difference in heart rate variability between both measurements (SCS on versus SCS off)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain intensity scores</measure>
    <time_frame>Two times on the same day; once while SCS is switched off and once while SCS is switched on. Total study duration lasts one day.</time_frame>
    <description>Pain intensity scores on a visual analogue scale ranging from zero (no pain) towards 10 (worst possible pain).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Failed Back Surgery Syndrome</condition>
  <arm_group>
    <arm_group_label>SCS off</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>SCS on</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>SCS is switched off</intervention_name>
    <description>Spinal cord stimulator is switched off for 12 hours</description>
    <arm_group_label>SCS off</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>SCS is switched on</intervention_name>
    <description>Spinal cord stimulator is on</description>
    <arm_group_label>SCS on</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is at least 18 years old.&#xD;
&#xD;
          -  Diagnosis of FBSS (Failed conservative treatments for pain including but not limited&#xD;
             to pharmacological therapy and physical therapy) and currently being treated with&#xD;
             spinal cord stimulation.&#xD;
&#xD;
          -  Cognitive and language functioning enabling coherent communication between the&#xD;
             examiner and the participant.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The presence of one or more coexisting conditions known to affect HRV analysis&#xD;
             (including but not limited to atrial fibrillation, numerous atrial or ventricular&#xD;
             extra beats, paced rhythm, left ventricular bundle branch block, cancer, kidney or&#xD;
             hepatic failure, and diabetes mellitus (autonomic nervous system dysfunction)).&#xD;
&#xD;
          -  The use of medication that directly modifies autonomic control (for example&#xD;
             beta-blockers).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maarten Moens, Prof. dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitair Ziekenhuis Brussel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UZ Brussel</name>
      <address>
        <city>Jette</city>
        <state>Brussel</state>
        <zip>1090</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <reference>
    <citation>Kalmar Z, Kovacs N, Balas I, Perlaki G, Plozer E, Orsi G, Altbacker A, Schwarcz A, Hejjel L, Komoly S, Janszky J. Effects of spinal cord stimulation on heart rate variability in patients with chronic pain. Ideggyogy Sz. 2013 Mar 30;66(3-4):102-6.</citation>
    <PMID>23750425</PMID>
  </reference>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>November 28, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>June 17, 2019</last_update_submitted>
  <last_update_submitted_qc>June 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Universitair Ziekenhuis Brussel</investigator_affiliation>
    <investigator_full_name>Moens Maarten</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <keyword>Spinal Cord Stimulation</keyword>
  <keyword>Heart rate variability</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Failed Back Surgery Syndrome</mesh_term>
  </condition_browse>
  <!-- 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/NCT03768791
org study id: SYNCHRO
nct id: NCT03768791
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study is an observatory single center study investigating heart rate variability during
      on and off states of the spinal cord stimulator, in patients with failed back surgery
      syndrome.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Heart rate variability changes
time frame: Two times on the same day; once while SCS is switched off and once while SCS is switched on. Total study duration lasts one day.
description: The investigators will examine the difference in heart rate variability between both measurements (SCS on versus SCS off)
measure: Pain intensity scores
time frame: Two times on the same day; once while SCS is switched off and once while SCS is switched on. Total study duration lasts one day.
description: Pain intensity scores on a visual analogue scale ranging from zero (no pain) towards 10 (worst possible pain).
arm group label: SCS off
arm group type: Experimental
arm group label: SCS on
arm group type: Experimental
intervention type: Other
intervention name: SCS is switched off
description: Spinal cord stimulator is switched off for 12 hours
arm group label: SCS off
intervention type: Other
intervention name: SCS is switched on
description: Spinal cord stimulator is on
arm group label: SCS on
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Maarten Moens, Prof. dr.
role: Principal Investigator
affiliation: Universitair Ziekenhuis Brussel
facility: 
country: Belgium
citation: Kalmar Z, Kovacs N, Balas I, Perlaki G, Plozer E, Orsi G, Altbacker A, Schwarcz A, Hejjel L, Komoly S, Janszky J. Effects of spinal cord stimulation on heart rate variability in patients with chronic pain. Ideggyogy Sz. 2013 Mar 30;66(3-4):102-6.
PMID: 23750425
responsible party type: Sponsor-Investigator
investigator affiliation: Universitair Ziekenhuis Brussel
investigator full name: Moens Maarten
investigator title: principal investigator
mesh term: Syndrome
mesh term: Failed Back Surgery Syndrome