<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/NCT02974101</url>
  </required_header>
  <id_info>
    <org_study_id>EMINENT1</org_study_id>
    <nct_id>NCT02974101</nct_id>
  </id_info>
  <brief_title>AdaptiveStim Objectifying Subjective Pain Questionnaires</brief_title>
  <acronym>EMINENT</acronym>
  <official_title>AdaptiveStim Objectifying Subjective Pain Questionnaires</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Moens Maarten</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medtronic</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Universitair Ziekenhuis Brussel</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, multi-center, correlation study in which the investigators aim to&#xD;
      explore the relationship between subjective pain questionnaires and the AdaptiveStim&#xD;
      accelerometer output.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this research is to gather the necessary information relating to the patient his&#xD;
      subjective self-report and the more objective information from the implanted IPG&#xD;
      (RestoreSensor). Such subjective information can be gathered from the AdaptivStim output.&#xD;
&#xD;
      The main focus of this study is to explore the relationship between the subjective reporting&#xD;
      of functional disability with the ODI, sleep quality with the Actiwatch and PSQI, pain&#xD;
      intensity with the NRS-diary and the objective measurement of functional positions with the&#xD;
      AdaptiveStim in patients receiving high density spinal cord stimulation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">May 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>AdaptiveStim output</measure>
    <time_frame>The change between baseline (T1) and the second assessment 7 days later (T1+7days)</time_frame>
    <description>The Implantable Pulse Generator contains a processor and accelerometer to record objective information about 7 functional positions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Disability</measure>
    <time_frame>Disability will be measured at the second assessment namely 7 days after the first assessment</time_frame>
    <description>Disability will be measured using the Oswestry Disability Index (ODI) questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Numeric Rating Scale (NRS) pain diary</measure>
    <time_frame>Three times every day (morning, afternoon and evening), during 7 days (from baseline assessment (T1) to second assessment (T1+7days))</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective sleep quality will be measured using the Actiwatch spectrum plus (Respironics).</measure>
    <time_frame>Three times every day (morning, afternoon and evening), during 7 days (from baseline assessment (T1) to second assessment (T1+7days))</time_frame>
    <description>This compact and lightweight electronic device similar in size to a wristwatch is worn on the non-dominant hand, and measures and records sleep quality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective sleep quality</measure>
    <time_frame>Disability will be measured at the second assessment namely 7 days after the first assessment</time_frame>
    <description>Subjective sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Failed Back Surgery Syndrome</condition>
  <arm_group>
    <arm_group_label>spinal cord stimulation(RestoreSensor)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>registration of AdaptiveStim</intervention_name>
    <arm_group_label>spinal cord stimulation(RestoreSensor)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  FBSS patients treated with SCS (IPG = RestoreSensor) who achieved a steady state&#xD;
             (steady state is considered when the parameters didn't changed for at least one month)&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with Parkinson's disease&#xD;
&#xD;
          -  Patients immobilised due to limb/pelvis/costal fractures&#xD;
&#xD;
          -  Stroke patients with MRS&gt;3&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>AZ Nikolaas</name>
      <address>
        <city>Sint-Niklaas</city>
        <state>Oost-Vlaanderen</state>
        <zip>9100</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Brussel</name>
      <address>
        <city>Brussels</city>
        <state>Vlaams Brabant</state>
        <zip>1090</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 25, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2016</study_first_posted>
  <last_update_submitted>July 12, 2017</last_update_submitted>
  <last_update_submitted_qc>July 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2017</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>Prof. dr.</investigator_title>
  </responsible_party>
  <keyword>Spinal cord stimulation</keyword>
  <keyword>AdaptiveStim</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT02974101
org study id: EMINENT1
nct id: NCT02974101
lead sponsor: 
collaborator: 
has dmc: No
This is a prospective, multi-center, correlation study in which the investigators aim to
      explore the relationship between subjective pain questionnaires and the AdaptiveStim
      accelerometer output.
The aim of this research is to gather the necessary information relating to the patient his
      subjective self-report and the more objective information from the implanted IPG
      (RestoreSensor). Such subjective information can be gathered from the AdaptivStim output.

      The main focus of this study is to explore the relationship between the subjective reporting
      of functional disability with the ODI, sleep quality with the Actiwatch and PSQI, pain
      intensity with the NRS-diary and the objective measurement of functional positions with the
      AdaptiveStim in patients receiving high density spinal cord stimulation.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: AdaptiveStim output
time frame: The change between baseline (T1) and the second assessment 7 days later (T1+7days)
description: The Implantable Pulse Generator contains a processor and accelerometer to record objective information about 7 functional positions.
measure: Disability
time frame: Disability will be measured at the second assessment namely 7 days after the first assessment
description: Disability will be measured using the Oswestry Disability Index (ODI) questionnaire
measure: Numeric Rating Scale (NRS) pain diary
time frame: Three times every day (morning, afternoon and evening), during 7 days (from baseline assessment (T1) to second assessment (T1+7days))
measure: Objective sleep quality will be measured using the Actiwatch spectrum plus (Respironics).
time frame: Three times every day (morning, afternoon and evening), during 7 days (from baseline assessment (T1) to second assessment (T1+7days))
description: This compact and lightweight electronic device similar in size to a wristwatch is worn on the non-dominant hand, and measures and records sleep quality
measure: Subjective sleep quality
time frame: Disability will be measured at the second assessment namely 7 days after the first assessment
description: Subjective sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI).
arm group label: spinal cord stimulation(RestoreSensor)
arm group type: Experimental
intervention type: Other
intervention name: registration of AdaptiveStim
arm group label: spinal cord stimulation(RestoreSensor)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: Belgium
responsible party type: Sponsor-Investigator
investigator affiliation: Universitair Ziekenhuis Brussel
investigator full name: Moens Maarten
investigator title: Prof. dr.
mesh term: Failed Back Surgery Syndrome