<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/NCT01696149</url>
  </required_header>
  <id_info>
    <org_study_id>87-4520</org_study_id>
    <nct_id>NCT01696149</nct_id>
  </id_info>
  <brief_title>Effects of High and Low Frequency TENS on Sympathetic Skin Response and Skin Temperature</brief_title>
  <official_title>The Effects of High and Low Frequency Transcutaneous Electrical Nerve Stimulation on Sympathetic Skin Response and Skin Temperature</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shiraz University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shiraz University of Medical Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study was to determine the effects of 4 Hz and 110 Hz transcutaneous&#xD;
      electrical nerve stimulation on the sympathetic nervous system via measuring the sympathetic&#xD;
      skin response (SSR) and skin temperature.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      15 healthy subjects (8 females, 7 males) with a mean age of 22.6 ± 3.7 years participated in&#xD;
      this study.&#xD;
&#xD;
      All subjects participated, randomly, in a 4 Hz TENS session, a 110 Hz TENS session, and a&#xD;
      control (off-TENS) session. Each session consisted of a 20- minute stimulation period and a&#xD;
      10-minute follow up period.&#xD;
&#xD;
      Outcome measures: Sympathetic skin response from the simulated (Right) hand and skin&#xD;
      temperature of both stimulated (Right) and none stimulated (Left) hand was measured 15&#xD;
      seconds before, just 15 seconds after, and 10 minutes after application of interventions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2010</start_date>
  <completion_date type="Actual">June 2011</completion_date>
  <primary_completion_date type="Actual">February 2011</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>Basic Science</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes of sympathetic skin response</measure>
    <time_frame>15 seconds before, just 15 seconds after, and 10 minutes after application of interventions</time_frame>
    <description>Sympathetic skin response from the simulated (Right) hand was measured 15 seconds before, just 15 seconds after, and 10 minutes after application of interventions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes of skin temperature</measure>
    <time_frame>15 seconds before, just 15 seconds after, and 10 minutes after application of interventions</time_frame>
    <description>skin temperature of both stimulated (Right) and none stimulated (Left) hand was measured 15 seconds before, just 15 seconds after, and 10 minutes after application of interventions</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Effects of TENS on Sympathetic Skin Response</condition>
  <arm_group>
    <arm_group_label>electrical nerve stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All subjects participated, randomly, in a 4 Hz transcutaneous electrical nerve stimulation session, a 110 Hz transcutaneous electrical nerve stimulation session, and a control (off-transcutaneous electrical nerve stimulation) session. Each session consisted of a 20- minute stimulation period and a 10-minute follow up period</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>transcutaneous electrical nerve stimulation</intervention_name>
    <description>All subjects participated, randomly, in a 4 Hz TENS session, a 110 Hz TENS session, and a control (off-TENS) session. Each session consisted of a 20- minute stimulation period and a 10-minute follow up period.</description>
    <arm_group_label>electrical nerve stimulation</arm_group_label>
    <other_name>TENS</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women aged 18 to 30 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of cardiovascular, neurologic or musculoskeletal disease&#xD;
&#xD;
          -  Taking medication at the time of the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Farzaneh Dehghan</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shiraz University of Medical Sciences</affiliation>
  </overall_official>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 18, 2012</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 28, 2012</study_first_posted>
  <last_update_submitted>September 27, 2012</last_update_submitted>
  <last_update_submitted_qc>September 27, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 28, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shiraz University of Medical Sciences</investigator_affiliation>
    <investigator_full_name>samaneh ebrahimi</investigator_full_name>
    <investigator_title>PhD candidate</investigator_title>
  </responsible_party>
  <keyword>TENS, sympathetic skin response, skin temperature</keyword>
  <!-- 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/NCT01696149
org study id: 87-4520
nct id: NCT01696149
lead sponsor: 
has dmc: Yes
The aim of this study was to determine the effects of 4 Hz and 110 Hz transcutaneous
      electrical nerve stimulation on the sympathetic nervous system via measuring the sympathetic
      skin response (SSR) and skin temperature.
15 healthy subjects (8 females, 7 males) with a mean age of 22.6 ± 3.7 years participated in
      this study.

      All subjects participated, randomly, in a 4 Hz TENS session, a 110 Hz TENS session, and a
      control (off-TENS) session. Each session consisted of a 20- minute stimulation period and a
      10-minute follow up period.

      Outcome measures: Sympathetic skin response from the simulated (Right) hand and skin
      temperature of both stimulated (Right) and none stimulated (Left) hand was measured 15
      seconds before, just 15 seconds after, and 10 minutes after application of interventions.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: Double (Participant, Outcomes Assessor)
measure: Changes of sympathetic skin response
time frame: 15 seconds before, just 15 seconds after, and 10 minutes after application of interventions
description: Sympathetic skin response from the simulated (Right) hand was measured 15 seconds before, just 15 seconds after, and 10 minutes after application of interventions.
measure: Changes of skin temperature
time frame: 15 seconds before, just 15 seconds after, and 10 minutes after application of interventions
description: skin temperature of both stimulated (Right) and none stimulated (Left) hand was measured 15 seconds before, just 15 seconds after, and 10 minutes after application of interventions
arm group label: electrical nerve stimulation
arm group type: Experimental
description: All subjects participated, randomly, in a 4 Hz transcutaneous electrical nerve stimulation session, a 110 Hz transcutaneous electrical nerve stimulation session, and a control (off-transcutaneous electrical nerve stimulation) session. Each session consisted of a 20- minute stimulation period and a 10-minute follow up period
intervention type: Device
intervention name: transcutaneous electrical nerve stimulation
description: All subjects participated, randomly, in a 4 Hz TENS session, a 110 Hz TENS session, and a control (off-TENS) session. Each session consisted of a 20- minute stimulation period and a 10-minute follow up period.
arm group label: electrical nerve stimulation
other name: TENS
criteria: 
gender: All
minimum age: 20 Years
maximum age: 30 Years
healthy volunteers: No
last name: Farzaneh Dehghan
role: Principal Investigator
affiliation: Shiraz University of Medical Sciences
responsible party type: Principal Investigator
investigator affiliation: Shiraz University of Medical Sciences
investigator full name: samaneh ebrahimi
investigator title: PhD candidate