<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/NCT03295370</url>
  </required_header>
  <id_info>
    <org_study_id>54489816.3.0000.5327</org_study_id>
    <nct_id>NCT03295370</nct_id>
  </id_info>
  <brief_title>Electrical Stimulation of Accessory Spinal Nerve in Cortical Activation and Autonomic Response in Healthy Subjects</brief_title>
  <official_title>Electrical Stimulation of Accessory Spinal Nerve in Cortical Activation, Muscular Perfusion and Autonomic Response in Healthy Subjects: a Randomized, Crossover, Sham Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital de Clinicas de Porto Alegre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital de Clinicas de Porto Alegre</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>
      This randomized, crossover sham controlled trial with sham intended to study the effect of&#xD;
      electrical stimulation on peripheral nerve (spinal accessory nerve) with acupuncture needle&#xD;
      in healthy subjects aims to access the effect o electrical stimulation of accessory spinal&#xD;
      nerve in cortical activation, muscular perfusion and autonomic response in healthy subjects.&#xD;
&#xD;
      Participants will be assessed through measure changes in cortical activation, local muscular&#xD;
      peripheral perfusion and autonomic responses before and after intervention and&#xD;
      intervention-sham, and crossed after a period of wash-out.&#xD;
&#xD;
      The design aims to contribute to assessment of one electroacupuncture's techniques by&#xD;
      measuring some of the physiological effects caused by peripheral stimulation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In recent years, there are growing evidence that many diseases such as chronic pain and&#xD;
      psychiatric disorders can be managed with non-pharmacological techniques. The possibility of&#xD;
      inducing central neuroplastic responses through transcranial magnetic stimulation (TMS) and&#xD;
      transcranial direct current stimulation (tDCS) has been widely studied, as well as peripheral&#xD;
      stimulation techniques such electroacupuncture (EA) and intramuscular stimulation (IMS).&#xD;
      However, there are few studies on physiological mechanisms, indications and limitations of&#xD;
      each technique.&#xD;
&#xD;
      Thus, this randomized, crossover sham controlled trial, where sham intended to study the&#xD;
      effect of electrical stimulation on peripheral nerve (spinal accessory nerve) with&#xD;
      acupuncture needle in healthy subjects aims to access the effect o electrical stimulation of&#xD;
      accessory spinal nerve in cortical activation, muscular perfusion and autonomic response in&#xD;
      healthy subjects.&#xD;
&#xD;
      Participants will be assessed through measure changes in cortical activation, local muscular&#xD;
      peripheral perfusion and autonomic responses before and after intervention and&#xD;
      intervention-sham, and crossed after a period of wash-out.&#xD;
&#xD;
      The design aims to contribute to assessment of one electroacupuncture's techniques by&#xD;
      measuring some of the physiological effects caused by peripheral stimulation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 13, 2017</start_date>
  <completion_date type="Actual">January 4, 2018</completion_date>
  <primary_completion_date type="Actual">January 4, 2018</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>Crossover Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cortical Activation</measure>
    <time_frame>12 minutes</time_frame>
    <description>The metabolic activation of motor cortex and dorsolateral prefrontal cortex , measured through infrared spectroscopy (fNIRS)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Muscular perfusion</measure>
    <time_frame>12 minutes</time_frame>
    <description>Muscular perfusion of trapezius muscle, peripherally measured through infrared spectroscopy (fNIRS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>20 minutes</time_frame>
    <description>blood pressure measurement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxygen saturation</measure>
    <time_frame>20 minutes</time_frame>
    <description>Oxygen measurement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac frequency</measure>
    <time_frame>20 minutes</time_frame>
    <description>Cardiac frequency measurement</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Active Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Needle electrical stimulation of accessory spinal nerve</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham Group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Needle of accessory spinal nerve without electrical stimulation</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Electrical Stimulation</intervention_name>
    <description>A needle is placed near accessory spinal nerve; electrical burst stimulation for 12 minutes, 10 Hz;</description>
    <arm_group_label>Active Group</arm_group_label>
    <arm_group_label>Sham Group</arm_group_label>
    <other_name>electroacupuncture</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy male subjects&#xD;
&#xD;
          -  right handed&#xD;
&#xD;
          -  basic education&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  contraindication to infrared technology NIRS&#xD;
&#xD;
          -  brain stimulator device&#xD;
&#xD;
          -  drug and alcohol abuse&#xD;
&#xD;
          -  chronic disease (any);&#xD;
&#xD;
          -  chronic pain condition&#xD;
&#xD;
          -  tobacco use&#xD;
&#xD;
          -  psychiatric disorders&#xD;
&#xD;
          -  Beck Depression Inventory higher then score 12&#xD;
&#xD;
          -  psychotropic drugs&#xD;
&#xD;
          -  use of pain-killers or anti-inflammatories 12h previous experiment&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital de Clinicas e Porto Alegre (HCPA)</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande Do Sul</state>
        <zip>90035-003</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>September 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 27, 2017</study_first_posted>
  <last_update_submitted>January 4, 2018</last_update_submitted>
  <last_update_submitted_qc>January 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital de Clinicas de Porto Alegre</investigator_affiliation>
    <investigator_full_name>Wolnei Caumo</investigator_full_name>
    <investigator_title>Surgery Department Professor, School of Medicine UFRGS - MD. PhD.</investigator_title>
  </responsible_party>
  <keyword>Pain mechanisms</keyword>
  <keyword>Cortical activation</keyword>
  <keyword>fNIRS</keyword>
  <keyword>Accessory spinal nerve</keyword>
  <keyword>Autonomic response</keyword>
  <keyword>Muscular perfusion</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03295370
org study id: 54489816.3.0000.5327
nct id: NCT03295370
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This randomized, crossover sham controlled trial with sham intended to study the effect of
      electrical stimulation on peripheral nerve (spinal accessory nerve) with acupuncture needle
      in healthy subjects aims to access the effect o electrical stimulation of accessory spinal
      nerve in cortical activation, muscular perfusion and autonomic response in healthy subjects.

      Participants will be assessed through measure changes in cortical activation, local muscular
      peripheral perfusion and autonomic responses before and after intervention and
      intervention-sham, and crossed after a period of wash-out.

      The design aims to contribute to assessment of one electroacupuncture's techniques by
      measuring some of the physiological effects caused by peripheral stimulation.
In recent years, there are growing evidence that many diseases such as chronic pain and
      psychiatric disorders can be managed with non-pharmacological techniques. The possibility of
      inducing central neuroplastic responses through transcranial magnetic stimulation (TMS) and
      transcranial direct current stimulation (tDCS) has been widely studied, as well as peripheral
      stimulation techniques such electroacupuncture (EA) and intramuscular stimulation (IMS).
      However, there are few studies on physiological mechanisms, indications and limitations of
      each technique.

      Thus, this randomized, crossover sham controlled trial, where sham intended to study the
      effect of electrical stimulation on peripheral nerve (spinal accessory nerve) with
      acupuncture needle in healthy subjects aims to access the effect o electrical stimulation of
      accessory spinal nerve in cortical activation, muscular perfusion and autonomic response in
      healthy subjects.

      Participants will be assessed through measure changes in cortical activation, local muscular
      peripheral perfusion and autonomic responses before and after intervention and
      intervention-sham, and crossed after a period of wash-out.

      The design aims to contribute to assessment of one electroacupuncture's techniques by
      measuring some of the physiological effects caused by peripheral stimulation.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: Cortical Activation
time frame: 12 minutes
description: The metabolic activation of motor cortex and dorsolateral prefrontal cortex , measured through infrared spectroscopy (fNIRS)
measure: Muscular perfusion
time frame: 12 minutes
description: Muscular perfusion of trapezius muscle, peripherally measured through infrared spectroscopy (fNIRS)
measure: Blood pressure
time frame: 20 minutes
description: blood pressure measurement
measure: Oxygen saturation
time frame: 20 minutes
description: Oxygen measurement
measure: Cardiac frequency
time frame: 20 minutes
description: Cardiac frequency measurement
arm group label: Active Group
arm group type: Experimental
description: Needle electrical stimulation of accessory spinal nerve
arm group label: Sham Group
arm group type: Sham Comparator
description: Needle of accessory spinal nerve without electrical stimulation
intervention type: Procedure
intervention name: Electrical Stimulation
description: A needle is placed near accessory spinal nerve; electrical burst stimulation for 12 minutes, 10 Hz;
arm group label: Active Group
arm group label: Sham Group
other name: electroacupuncture
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Hospital de Clinicas de Porto Alegre
investigator full name: Wolnei Caumo
investigator title: Surgery Department Professor, School of Medicine UFRGS - MD. PhD.
sharing ipd: Undecided