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/NCT06025643</url>
    </required_header>
    <id_info>
      <org_study_id>PressureStim</org_study_id>
      <nct_id>NCT06025643</nct_id>
    </id_info>
    <brief_title>Effects of Electrical Nervous Stimulation Transcutaneous in Hypertensive Patients</brief_title>
    <official_title>Effects of Electrical Nervous Stimulation Transcutaneous Analysis on Blood Pressure of Patients Hypertensive: Randomized Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Federal University of Health Science of Porto Alegre</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Irmandade Santa Casa de Misericórdia de Porto Alegre</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Leonhardt Ventures LLC</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Federal University of Health Science of Porto Alegre</source>
    <oversight_info>
      <has_dmc>Yes</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>
        Systemic arterial hypertension is a disease characterized by high blood pressure levels. It&#xD;
        has a high prevalence, is a precursor of cardiovascular diseases, resulting in high costs to&#xD;
        the health system and increased mortality. Transcutaneous electrical nerve stimulation (TENS)&#xD;
        is a low-frequency pulsed electrical current widely used for analgesia. Recently, it has been&#xD;
        proposed as a non-pharmacological strategy for blood pressure control. The aim of this study&#xD;
        is to verify the effect of low-frequency TENS when applied in different anatomical sites on&#xD;
        blood pressure, autonomic control and endothelial function in hypertensive patients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Systemic arterial hypertension is a disease characterized by high blood pressure levels. It&#xD;
        has a high prevalence, is a precursor of cardiovascular diseases, resulting in high costs to&#xD;
        the health system and increased mortality. Transcutaneous electrical nerve stimulation (TENS)&#xD;
        is a low-frequency pulsed electrical current widely used for analgesia. Recently, it has been&#xD;
        proposed as a non-pharmacological strategy for blood pressure control. The aim of this study&#xD;
        is to verify the effect of low-frequency TENS when applied in different anatomical sites on&#xD;
        blood pressure, autonomic control and endothelial function in hypertensive patients. For&#xD;
        this, patients will be randomized into 4 groups: group 1 (cervical stimulation), group 2&#xD;
        (plus cervical stimulation ), group 3 (renal stimulation), group 4 (control). Group 1 will&#xD;
        receive TENS in the cervical paravertebral region; group 2 will receive stimulation in the&#xD;
        cervical paravertebral region, ear lobe, wrist and ankle. Group 3 will have the anatomical&#xD;
        region of the kidneys stimulated. Group 4 will not receive any intervention. All the treated&#xD;
        patients will receive 30 minutes of stimulation per session, regardless of group allocation.&#xD;
        Ten applications will be carried out over the course of a month.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 4, 2023</start_date>
    <completion_date type="Anticipated">February 4, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 4, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Systolic blood pressure</measure>
      <time_frame>Baseline and after 4 weeks</time_frame>
      <description>Systolic blood pressure assessed by ambulatory blood pressure monitoring (ABPM)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Diastolic blood pressure</measure>
      <time_frame>Baseline and after 4 weeks</time_frame>
      <description>Systolic blood pressure assessed by ambulatory blood pressure monitoring (ABPM)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Autonomic control</measure>
      <time_frame>Baseline and after 4 weeks</time_frame>
      <description>Autonomic control assessed by analysis of heart rate variability by frequency meter</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Hypertension</condition>
    <condition>Hypertension,Essential</condition>
    <arm_group>
      <arm_group_label>Cervical stimulation group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>TENS will be applied for 30 minutes with a frequency of 5 Hz, pulse width of 200 µs and sufficient intensity to reach the sensory threshold. Ten sessions will be performed over four weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Plus cervical stimulation group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>TENS will be applied for 30 minutes with a frequency of 5 Hz, pulse width of 200 µs and sufficient intensity to reach the sensory threshold. Ten sessions will be performed over four weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Renal stimulation group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>TENS will be applied for 30 minutes with a frequency of 5 Hz, pulse width of 200 µs and sufficient intensity to reach the sensory threshold. Ten sessions will be performed over four weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>This group will not receive any treatment with electrical stimulation.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>TENS - Cervical stimulation group</intervention_name>
      <description>TENS will be applied bilaterally through self-adhesive electrodes in the cervicothoracic ganglionic region, located between the C7 and T4 vertebral processes.</description>
      <arm_group_label>Cervical stimulation group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>TENS - Plus cervical stimulation group</intervention_name>
      <description>TENS will be applied bilaterally in the cervicothoracic ganglionic region, located between the C7 and T4 vertebral processes, on the earlobe, on the wrists and ankles simultaneously.</description>
      <arm_group_label>Plus cervical stimulation group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>TENS - Renal stimulation group</intervention_name>
      <description>TENS will be applied through self-adhesive electrodes in the abdomen (anatomical region corresponding to the kidneys) and dorsal region at the level of the 10th thoracic vertebra.</description>
      <arm_group_label>Renal stimulation group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          - Diagnosis of systemic arterial hypertension: systolic blood pressure (SBP) ≥ 130 mmHg and&#xD;
          diastolic blood pressure (DBP) ≥ 80 mmHg diagnosed by ambulatory blood pressure monitoring&#xD;
          (ABPM).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Congestive heart failure&#xD;
  &#xD;
            -  Patients with a cardiac pacemaker&#xD;
  &#xD;
            -  Previous heart surgery&#xD;
  &#xD;
            -  Patients with serum creatinine &gt;2.5 mg/dL&#xD;
  &#xD;
            -  Change in drug therapy in the two months prior to starting the study&#xD;
  &#xD;
            -  Active smoking&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Rodrigo DM Plentz, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Federal University of Health Sciences of Porto Alegre</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jociane Schardong, PhD</last_name>
      <phone>55981348114</phone>
      <email>joci_fisioufsm@yahoo.com.br</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Federal University of Health Science of Porto Alegre</investigator_affiliation>
      <investigator_full_name>Jociane Schardong</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hypertension</mesh_term>
      <mesh_term>Essential Hypertension</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06025643
  org study id: PressureStim
  nct id: NCT06025643
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Systemic arterial hypertension is a disease characterized by high blood pressure levels. It
        has a high prevalence, is a precursor of cardiovascular diseases, resulting in high costs to
        the health system and increased mortality. Transcutaneous electrical nerve stimulation (TENS)
        is a low-frequency pulsed electrical current widely used for analgesia. Recently, it has been
        proposed as a non-pharmacological strategy for blood pressure control. The aim of this study
        is to verify the effect of low-frequency TENS when applied in different anatomical sites on
        blood pressure, autonomic control and endothelial function in hypertensive patients.
  Systemic arterial hypertension is a disease characterized by high blood pressure levels. It
        has a high prevalence, is a precursor of cardiovascular diseases, resulting in high costs to
        the health system and increased mortality. Transcutaneous electrical nerve stimulation (TENS)
        is a low-frequency pulsed electrical current widely used for analgesia. Recently, it has been
        proposed as a non-pharmacological strategy for blood pressure control. The aim of this study
        is to verify the effect of low-frequency TENS when applied in different anatomical sites on
        blood pressure, autonomic control and endothelial function in hypertensive patients. For
        this, patients will be randomized into 4 groups: group 1 (cervical stimulation), group 2
        (plus cervical stimulation ), group 3 (renal stimulation), group 4 (control). Group 1 will
        receive TENS in the cervical paravertebral region; group 2 will receive stimulation in the
        cervical paravertebral region, ear lobe, wrist and ankle. Group 3 will have the anatomical
        region of the kidneys stimulated. Group 4 will not receive any intervention. All the treated
        patients will receive 30 minutes of stimulation per session, regardless of group allocation.
        Ten applications will be carried out over the course of a month.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Systolic blood pressure
  time frame: Baseline and after 4 weeks
  description: Systolic blood pressure assessed by ambulatory blood pressure monitoring (ABPM)
  measure: Diastolic blood pressure
  time frame: Baseline and after 4 weeks
  description: Systolic blood pressure assessed by ambulatory blood pressure monitoring (ABPM)
  measure: Autonomic control
  time frame: Baseline and after 4 weeks
  description: Autonomic control assessed by analysis of heart rate variability by frequency meter
  arm group label: Cervical stimulation group
  arm group type: Experimental
  description: TENS will be applied for 30 minutes with a frequency of 5 Hz, pulse width of 200 µs and sufficient intensity to reach the sensory threshold. Ten sessions will be performed over four weeks.
  arm group label: Plus cervical stimulation group
  arm group type: Experimental
  description: TENS will be applied for 30 minutes with a frequency of 5 Hz, pulse width of 200 µs and sufficient intensity to reach the sensory threshold. Ten sessions will be performed over four weeks.
  arm group label: Renal stimulation group
  arm group type: Experimental
  description: TENS will be applied for 30 minutes with a frequency of 5 Hz, pulse width of 200 µs and sufficient intensity to reach the sensory threshold. Ten sessions will be performed over four weeks.
  arm group label: Control group
  arm group type: No Intervention
  description: This group will not receive any treatment with electrical stimulation.
  intervention type: Other
  intervention name: TENS - Cervical stimulation group
  description: TENS will be applied bilaterally through self-adhesive electrodes in the cervicothoracic ganglionic region, located between the C7 and T4 vertebral processes.
  arm group label: Cervical stimulation group
  intervention type: Other
  intervention name: TENS - Plus cervical stimulation group
  description: TENS will be applied bilaterally in the cervicothoracic ganglionic region, located between the C7 and T4 vertebral processes, on the earlobe, on the wrists and ankles simultaneously.
  arm group label: Plus cervical stimulation group
  intervention type: Other
  intervention name: TENS - Renal stimulation group
  description: TENS will be applied through self-adhesive electrodes in the abdomen (anatomical region corresponding to the kidneys) and dorsal region at the level of the 10th thoracic vertebra.
  arm group label: Renal stimulation group
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Rodrigo DM Plentz, PhD
  role: Principal Investigator
  affiliation: Federal University of Health Sciences of Porto Alegre
  last name: Jociane Schardong, PhD
  phone: 55981348114
  email: joci_fisioufsm@yahoo.com.br
  responsible party type: Principal Investigator
  investigator affiliation: Federal University of Health Science of Porto Alegre
  investigator full name: Jociane Schardong
  investigator title: Principal Investigator
  mesh term: Hypertension
  mesh term: Essential Hypertension
  sharing ipd: No