xml: <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/NCT05966922</url>
    </required_header>
    <id_info>
      <org_study_id>ISTPMRTENS1</org_study_id>
      <nct_id>NCT05966922</nct_id>
    </id_info>
    <brief_title>Transcutaneous Electrical Stimulation &amp; Sinoatrial Node Function</brief_title>
    <acronym>TENS&amp;HR</acronym>
    <official_title>Effects of Transcutaneous Electrical Stimulation on the Sinoatrial Node Function</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Istanbul Physical Medicine Rehabilitation Training and Research Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Istanbul Physical Medicine Rehabilitation Training and Research Hospital</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Transcutaneous electrical stimulation (TES) is used in clinical practice to diagnose or treat&#xD;
        a diverse range of medical conditions for over a century. Although the benefits of TES are&#xD;
        well known, its potential side effects on the heart have not been convincingly clarified.&#xD;
        This study will test whether TES has any effect on the sinoatrial node (SAN).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        It was hypothesized that: 1) TES has effects indirectly via peripheral afferents or directly&#xD;
        on the SAN, and 2) TES causes a change in the R-R interval (HRV). The aim of this study was&#xD;
        to test these hypotheses.&#xD;
  &#xD;
        This research protocol will have three phases: first, the effect of a single electrical pulse&#xD;
        on heart rate variability (HRV) will be examined in Experiment I. The effects of conventional&#xD;
        TENS and acupuncture-like TENS on HRV will be also investigated in Experiment II. Finally,&#xD;
        the effect of time and rest on the HRV will be tested in Experiment III. Subjects will be in&#xD;
        a sitting position with 90-degree flexion at the elbow and supination of the hand during&#xD;
        electrical stimulation. A pair of square (4 x 4 cm), self-adhesive, pre-gelled skin&#xD;
        electrodes will be used for stimulation. The electrodes will be placed over the flexor aspect&#xD;
        of the right forearm. Three-lead electrocardiogram (ECG) recording will be obtained to&#xD;
        determine the change of HRV during rest and electrical stimulation sessions. The&#xD;
        participant's ECG data will be continuously captured by noninvasive sensors [self-adhesive&#xD;
        pre-gelled Ag/AgCl surface electromyography (sEMG) electrodes, Redline® Istanbul, Türkiye]&#xD;
        transmitted through a data acquisition system.&#xD;
  &#xD;
        The main outcome variable is the heart rhythm. In this context, electrical stimulus-related&#xD;
        QRS wave and RR interval change (heart rate variability) will be examined. The possible&#xD;
        direct effect of an electrical stimulus on the appearance of the QRS wave will be&#xD;
        investigated in the time domain using the Peristimulus time histogram and the Waveform&#xD;
        average technique. ECG data will be analyzed using a software package (Cambridge Electronic&#xD;
        Designs, Cambridge, UK).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">July 13, 2023</start_date>
    <completion_date type="Actual">August 1, 2023</completion_date>
    <primary_completion_date type="Actual">July 31, 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>
      <intervention_model_description>This study will be conducted in an experimental study design.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Heart rate</measure>
      <time_frame>up to 2 weeks</time_frame>
      <description>RR interval will be calculated</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Heart rate variability</measure>
      <time_frame>up to 2 weeks</time_frame>
      <description>Variability of RR interval will be calculated</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">34</enrollment>
    <condition>Electricity; Effects</condition>
    <condition>Heart Arrhythmia</condition>
    <arm_group>
      <arm_group_label>Electrical Stimulation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Electrical Stimulation and Sham will be delivered transcutaneously in random consecutive sessions</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Transcutaneous Electrical Stimulation</intervention_name>
      <description>Electrical Stimulation and a sham will be administered through the skin in random consecutive sessions in a study group. A single monophasic square electrical pulse and transcutaneous electrical nerve stimulation will be applied to the forearm volar aspect.</description>
      <arm_group_label>Electrical Stimulation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Healthy young adult volunteer&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  Alcohol or drug abuse,&#xD;
  &#xD;
            -  Any medication with potential effects on the cardiovascular system&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>İLHAN KARACAN, MD, Prof</last_name>
      <role>Study Chair</role>
      <affiliation>İstanbul Physical Therapy Rehabilitation Training &amp; Research Hosptial</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>İstanbul Physical Therapy Training and Research Hospital</name>
        <address>
          <city>Istanbul</city>
          <zip>34180</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 13, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>August 19, 2023</last_update_submitted>
    <last_update_submitted_qc>August 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Transcutaneous electrical nerve stimulation</keyword>
    <keyword>Neuromuscular electrical stimulation</keyword>
    <keyword>Heart rhythm</keyword>
    <keyword>heart rate variability</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Arrhythmias, Cardiac</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05966922
  org study id: ISTPMRTENS1
  nct id: NCT05966922
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Transcutaneous electrical stimulation (TES) is used in clinical practice to diagnose or treat
        a diverse range of medical conditions for over a century. Although the benefits of TES are
        well known, its potential side effects on the heart have not been convincingly clarified.
        This study will test whether TES has any effect on the sinoatrial node (SAN).
  It was hypothesized that: 1) TES has effects indirectly via peripheral afferents or directly
        on the SAN, and 2) TES causes a change in the R-R interval (HRV). The aim of this study was
        to test these hypotheses.
  
        This research protocol will have three phases: first, the effect of a single electrical pulse
        on heart rate variability (HRV) will be examined in Experiment I. The effects of conventional
        TENS and acupuncture-like TENS on HRV will be also investigated in Experiment II. Finally,
        the effect of time and rest on the HRV will be tested in Experiment III. Subjects will be in
        a sitting position with 90-degree flexion at the elbow and supination of the hand during
        electrical stimulation. A pair of square (4 x 4 cm), self-adhesive, pre-gelled skin
        electrodes will be used for stimulation. The electrodes will be placed over the flexor aspect
        of the right forearm. Three-lead electrocardiogram (ECG) recording will be obtained to
        determine the change of HRV during rest and electrical stimulation sessions. The
        participant's ECG data will be continuously captured by noninvasive sensors [self-adhesive
        pre-gelled Ag/AgCl surface electromyography (sEMG) electrodes, Redline® Istanbul, Türkiye]
        transmitted through a data acquisition system.
  
        The main outcome variable is the heart rhythm. In this context, electrical stimulus-related
        QRS wave and RR interval change (heart rate variability) will be examined. The possible
        direct effect of an electrical stimulus on the appearance of the QRS wave will be
        investigated in the time domain using the Peristimulus time histogram and the Waveform
        average technique. ECG data will be analyzed using a software package (Cambridge Electronic
        Designs, Cambridge, UK).
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: This study will be conducted in an experimental study design.
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Heart rate
  time frame: up to 2 weeks
  description: RR interval will be calculated
  measure: Heart rate variability
  time frame: up to 2 weeks
  description: Variability of RR interval will be calculated
  arm group label: Electrical Stimulation
  arm group type: Experimental
  description: Electrical Stimulation and Sham will be delivered transcutaneously in random consecutive sessions
  intervention type: Procedure
  intervention name: Transcutaneous Electrical Stimulation
  description: Electrical Stimulation and a sham will be administered through the skin in random consecutive sessions in a study group. A single monophasic square electrical pulse and transcutaneous electrical nerve stimulation will be applied to the forearm volar aspect.
  arm group label: Electrical Stimulation
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 45 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: İLHAN KARACAN, MD, Prof
  role: Study Chair
  affiliation: İstanbul Physical Therapy Rehabilitation Training & Research Hosptial
  facility: 
  country: Turkey
  responsible party type: Sponsor
  mesh term: Arrhythmias, Cardiac