<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/NCT02265042</url>
  </required_header>
  <id_info>
    <org_study_id>2012-13</org_study_id>
    <nct_id>NCT02265042</nct_id>
  </id_info>
  <brief_title>Effect of Electrostimulation on Denervated Muscles in Individuals With Spinal Cord Injury</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Swiss Paraplegic Centre Nottwil</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Swiss Paraplegic Centre Nottwil</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to investigate whether there is an effect of electrical stimulation&#xD;
      on the denervated gluteus muscle (buttocks) in individuals with chronic spinal cord injury.&#xD;
      The expected outcome is an increase in muscle volume and a better pressure distribution&#xD;
      during sitting. The stimulation of the gluteus muscle is performed daily for 35 minutes over&#xD;
      a period of six months. The muscle volume and the pressure distribution are measured before&#xD;
      stimulation, three months after having started stimulation and after six months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 2012</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">June 2023</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>change in muscle volume</measure>
    <time_frame>day 0 to 3 months</time_frame>
    <description>determination of muscle volume using magnetic resonance images</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>change in muscle volume</measure>
    <time_frame>3 months to 6 months</time_frame>
    <description>determination of muscle volume using magnetic resonance images</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in sitting pressure</measure>
    <time_frame>day 0 to 3 months</time_frame>
    <description>pressure mapping system</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in sitting pressure</measure>
    <time_frame>3 months to 6 months</time_frame>
    <description>pressure mapping system</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in quality of life</measure>
    <time_frame>day 0 to 3months</time_frame>
    <description>questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in quality of life</measure>
    <time_frame>3 months to 6 months</time_frame>
    <description>questionnaire</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Spinal Cord Injury</condition>
  <arm_group>
    <arm_group_label>electrical stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>electrical Stimulation using the Stimulette device</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Stimulette</intervention_name>
    <description>electrical stimulation device by Dr. Schuhfried Medizintechnik GmbH, Vienna, Austria</description>
    <arm_group_label>electrical stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  chronic spinal cord injury (min. 2 years after injury)&#xD;
&#xD;
          -  lesion height from T10-L5&#xD;
&#xD;
          -  ASIA (American Spinal Cord Injury Association) Impairment Scale A&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  acute pressure sore in stimulated area (M. gluteus)&#xD;
&#xD;
          -  arteriosclerosis&#xD;
&#xD;
          -  skin irritation or infection in stimulated area (M. gluteus)&#xD;
&#xD;
          -  &lt; 3 months after plastic surgery in stimulated area (M. gluteus)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ines Bersch-Porada</last_name>
    <phone>+41 41 939 4206</phone>
    <email>ines.bersch@paraplegie.ch</email>
  </overall_contact>
  <location>
    <facility>
      <name>Swiss Paraplegic Centre</name>
      <address>
        <city>Nottwil</city>
        <state>LU</state>
        <zip>6207</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ines Bersch-Porada</last_name>
      <phone>+41 41 939 42 06</phone>
      <email>ines.bersch@paraplegie.ch</email>
    </contact>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>October 7, 2014</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>February 24, 2022</last_update_submitted>
  <last_update_submitted_qc>February 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 25, 2022</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>Spinal Cord Injuries</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/NCT02265042
org study id: 2012-13
nct id: NCT02265042
lead sponsor: 
has dmc: No
The aim of the study is to investigate whether there is an effect of electrical stimulation
      on the denervated gluteus muscle (buttocks) in individuals with chronic spinal cord injury.
      The expected outcome is an increase in muscle volume and a better pressure distribution
      during sitting. The stimulation of the gluteus muscle is performed daily for 35 minutes over
      a period of six months. The muscle volume and the pressure distribution are measured before
      stimulation, three months after having started stimulation and after six months.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: change in muscle volume
time frame: day 0 to 3 months
description: determination of muscle volume using magnetic resonance images
measure: change in muscle volume
time frame: 3 months to 6 months
description: determination of muscle volume using magnetic resonance images
measure: change in sitting pressure
time frame: day 0 to 3 months
description: pressure mapping system
measure: change in sitting pressure
time frame: 3 months to 6 months
description: pressure mapping system
measure: change in quality of life
time frame: day 0 to 3months
description: questionnaire
measure: change in quality of life
time frame: 3 months to 6 months
description: questionnaire
arm group label: electrical stimulation
arm group type: Experimental
description: electrical Stimulation using the Stimulette device
intervention type: Device
intervention name: Stimulette
description: electrical stimulation device by Dr. Schuhfried Medizintechnik GmbH, Vienna, Austria
arm group label: electrical stimulation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Ines Bersch-Porada
phone: +41 41 939 4206
email: ines.bersch@paraplegie.ch
facility: 
status: Recruiting
contact: 
country: Switzerland
responsible party type: Sponsor
mesh term: Spinal Cord Injuries