<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/NCT01724307</url>
  </required_header>
  <id_info>
    <org_study_id>2011H0009</org_study_id>
    <nct_id>NCT01724307</nct_id>
  </id_info>
  <brief_title>Stimulation of the Cervical Sympathetic Ganglion for Treatment of Asthma</brief_title>
  <official_title>Stimulation of the Cervical Sympathetic Ganglion for Treatment of Asthma.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jonathan Parsons</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ohio State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate if stimulating the nerve involved with airway&#xD;
      constriction, while undergoing procedures that are known to cause asthma exacerbations,&#xD;
      decreases the level of asthma attack experienced.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Asthma is a chronic inflammatory disorder of the airways characterized by shortness of&#xD;
      breath, wheezing, cough, and fatigue. Some people suffer from sudden worsening of asthma&#xD;
      symptoms despite being treated with medications. When people have asthma attacks the muscle&#xD;
      tissue in the airway contracts causing the airway to narrow and decreasing the ability for&#xD;
      the person to breathe.&#xD;
&#xD;
      Neurological pacemakers are FDA approved devices that stimulate nerves in the body and have&#xD;
      been used for the treatment of many disorders such as Parkinson's, epilepsy, chronic pain and&#xD;
      urinary incontinence. Recent animal studies have shown that stimulating (activating a nerve)&#xD;
      the carotid sheath area (located in the neck) can cause the rapid relaxation of the muscles&#xD;
      which contract during an asthma attack. This approach has also been successfully used in&#xD;
      patients at an emergency room when they came in with a severe asthma attack.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2011</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">November 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate if neurostimulation of stellate ganglion modulates airway hyperresponsiveness to bronchoprovocation testing. Comparison of FEV1 drop before and after neurostimulation testing will be primary outcome measure</measure>
    <time_frame>60 minutes post treatment</time_frame>
    <description>To determine whether neurostimulation of the stellate ganglion modulates airway hyperresponsiveness to bronchoprovocation testing in asthmatics</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluate if neurostimulation of the stellate ganglion modulates airway inflammation</measure>
    <time_frame>60 minutes post treatment</time_frame>
    <description>To determine whether neurostimulation of the stellate ganglion modulates airway inflammation as measured by exhaled nitric oxide in asthmatics</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Asthma positive to Methacholine Challenge Testing</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Asthma diagnosis by positive Methacholine Challenge Testing</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Asthma positive to Eucapnic voluntary hyperventilation testing</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Asthma diagnosis by positive Eucapnic voluntary hyperventilation testing</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Neurostimulation of stellate ganglion</intervention_name>
    <description>An electrical nuerostimulation of the stellate ganglion up to 60 minutes</description>
    <arm_group_label>Asthma positive to Eucapnic voluntary hyperventilation testing</arm_group_label>
    <arm_group_label>Asthma positive to Methacholine Challenge Testing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. All patients aged 18-70 years of age suffering from mild-to-moderate asthma who have&#xD;
             either:&#xD;
&#xD;
               1. bronchial hyper-responsiveness to MCT&#xD;
&#xD;
               2. bronchial hyper-responsiveness to EVH testing&#xD;
&#xD;
          2. All patients with documented evidence of a positive MCT or EVH test within 36 months&#xD;
             of Visit 1&#xD;
&#xD;
          3. Are capable of reading and understanding questionnaires and providing written informed&#xD;
             consent.&#xD;
&#xD;
          4. Are willing and able to adhere to the study visit schedule and other&#xD;
             protocol-specified procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Non-English speaking.&#xD;
&#xD;
          2. Subjects experiencing an exacerbation of asthma within 6 weeks of Visit 1&#xD;
&#xD;
          3. Subjects with a forced expiratory volume (FEV1) ≤ 60% predicted, on spirometry&#xD;
&#xD;
          4. Subjects and medications:&#xD;
&#xD;
               1. Subjects allergic to methacholine or any other parasympathomimetic agent&#xD;
&#xD;
               2. Subjects on investigational drugs or participating in interventional research&#xD;
                  trial(s), 30 days prior to enrollment or during the duration of the study&#xD;
&#xD;
               3. Subjects currently on β-adrenergic blockers or, a cholinesterase inhibitor&#xD;
&#xD;
               4. Prior to the administering of the MCT/ EVH test:&#xD;
&#xD;
             i) use of a short-acting bronchodilator (within 6hrs.) ii) use of a long-acting&#xD;
             bronchodilator (within 36hrs.) iii) use of inhaled corticosteroids/ leukotriene&#xD;
             modifiers (within 72hrs.) iv) exercise (within 4hrs.)&#xD;
&#xD;
          5. Subject smoking: in the last 6 months or a smoking history of &gt;10 pack-years&#xD;
&#xD;
          6. Subjects who have experienced a febrile illness within 3 weeks of Visit 1&#xD;
&#xD;
          7. Subjects with a history of active poorly controlled epilepsy, cardiovascular disease&#xD;
             (esp. with bradycardia), vagotonia, peptic ulcer disease, thyroid disease, or urinary&#xD;
             tract obstruction or other chronic ailments that would interfere with the current&#xD;
             study&#xD;
&#xD;
          8. Subjects who are pregnant or refuse medically acceptable contraception during the&#xD;
             study period&#xD;
&#xD;
          9. Subjects with a history of &gt;3 stellate ganglion block procedures&#xD;
&#xD;
         10. Subjects who have undergone surgical procedures involving the cervical spine&#xD;
&#xD;
         11. Evidence of coagulopathy with abnormal INR, PT/ PTT and platelet count&#xD;
&#xD;
         12. Subjects allergic to lidocaine (Subject may still participate in the study if they&#xD;
             agree to the procedure without using the Lidoderm patch)&#xD;
&#xD;
         13. Subjects participating in another interventional research trial&#xD;
&#xD;
         14. Subjects with a condition or compliance issue, which in the investigator's opinion&#xD;
             might interfere with participation in the current study&#xD;
&#xD;
         15. Subjects unable or unwilling to provide a written consent to undergo the required&#xD;
             testing/ procedures/ physical exam or answer the questionnaires&#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_official>
    <last_name>Jonathan P Parsons, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ohio State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Ohio State University</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43221</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>October 9, 2012</study_first_submitted>
  <study_first_submitted_qc>November 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 9, 2012</study_first_posted>
  <last_update_submitted>January 25, 2016</last_update_submitted>
  <last_update_submitted_qc>January 25, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 27, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Ohio State University</investigator_affiliation>
    <investigator_full_name>Jonathan Parsons</investigator_full_name>
    <investigator_title>M.D.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</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/NCT01724307
org study id: 2011H0009
nct id: NCT01724307
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate if stimulating the nerve involved with airway
      constriction, while undergoing procedures that are known to cause asthma exacerbations,
      decreases the level of asthma attack experienced.
Asthma is a chronic inflammatory disorder of the airways characterized by shortness of
      breath, wheezing, cough, and fatigue. Some people suffer from sudden worsening of asthma
      symptoms despite being treated with medications. When people have asthma attacks the muscle
      tissue in the airway contracts causing the airway to narrow and decreasing the ability for
      the person to breathe.

      Neurological pacemakers are FDA approved devices that stimulate nerves in the body and have
      been used for the treatment of many disorders such as Parkinson's, epilepsy, chronic pain and
      urinary incontinence. Recent animal studies have shown that stimulating (activating a nerve)
      the carotid sheath area (located in the neck) can cause the rapid relaxation of the muscles
      which contract during an asthma attack. This approach has also been successfully used in
      patients at an emergency room when they came in with a severe asthma attack.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Evaluate if neurostimulation of stellate ganglion modulates airway hyperresponsiveness to bronchoprovocation testing. Comparison of FEV1 drop before and after neurostimulation testing will be primary outcome measure
time frame: 60 minutes post treatment
description: To determine whether neurostimulation of the stellate ganglion modulates airway hyperresponsiveness to bronchoprovocation testing in asthmatics
measure: Evaluate if neurostimulation of the stellate ganglion modulates airway inflammation
time frame: 60 minutes post treatment
description: To determine whether neurostimulation of the stellate ganglion modulates airway inflammation as measured by exhaled nitric oxide in asthmatics
arm group label: Asthma positive to Methacholine Challenge Testing
arm group type: Active Comparator
description: Asthma diagnosis by positive Methacholine Challenge Testing
arm group label: Asthma positive to Eucapnic voluntary hyperventilation testing
arm group type: Active Comparator
description: Asthma diagnosis by positive Eucapnic voluntary hyperventilation testing
intervention type: Procedure
intervention name: Neurostimulation of stellate ganglion
description: An electrical nuerostimulation of the stellate ganglion up to 60 minutes
arm group label: Asthma positive to Eucapnic voluntary hyperventilation testing
arm group label: Asthma positive to Methacholine Challenge Testing
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Jonathan P Parsons, M.D.
role: Principal Investigator
affiliation: Ohio State University
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Ohio State University
investigator full name: Jonathan Parsons
investigator title: M.D.
mesh term: Asthma