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/NCT06009159</url>
    </required_header>
    <id_info>
      <org_study_id>2023P001211</org_study_id>
      <nct_id>NCT06009159</nct_id>
    </id_info>
    <brief_title>Vagus Nerve Stimulation(VNS) As Treatment For Fibromyalgia Patients</brief_title>
    <official_title>Vagus Nerve Stimulation(VNS) As Treatment For Fibromyalgia Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Massachusetts General Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Massachusetts General 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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Fibromyalgia (FM) is a syndrome with clinical symptoms involving multiple systems. The&#xD;
        efficacy of current treatments is inadequate, and more alternative modalities are needed for&#xD;
        the management of FM patients. The parasympathetic vagus nerve innervates and integrates&#xD;
        sensory, motor, and autonomic systems and has been suggested to play a role in pain&#xD;
        modulation. The role of vagus nerve stimulation (VNS) as a treatment option for FM patients&#xD;
        is yet to be investigated. The investigators propose to examine the hypothesis that vagus&#xD;
        nerve stimulation could improve pain and related comorbid symptoms for FM patients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The main goal of this study is to generate preliminary data on the effect of VNS on FM&#xD;
        symptoms. Specifically, the investigators will utilize a recently developed, non-invasive&#xD;
        method of tVNS (transcutaneous VNS) via auricular branches of vagus nerve (ABVN). The&#xD;
        investigators plan to conduct an 8-week crossover clinical study with 30 subjects (tVNS vs.&#xD;
        control; crossover to control vs. tVNS; 4 weeks per period). The primary outcome measure will&#xD;
        be pain intensity. The secondary outcome measures will be fatigue, sleep, and other&#xD;
        health-related quality of life measure. These outcome measures will be made at baseline week&#xD;
        0 (before any intervention), after first 4 weeks of tVNS treatment or control before&#xD;
        crossover, and at the end of the entire study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">October 31, 2025</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>
      <intervention_model_description>8-week crossover clinical study with 30 subjects (tVNS vs. control; crossover to control vs. tVNS; 4 weeks per period)</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>A modified McGill Pain Questionnaire</measure>
      <time_frame>at 0,4,8 weeks of the study,</time_frame>
      <description>Pain intensity, 0-10 score, with 0 means no pain and 10 means worst pain</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Multidimensional Fatigue Inventory</measure>
      <time_frame>at 0,4,8 weeks of the study</time_frame>
      <description>Fatigue level, 1-5 score, base on the statement, answer 1 means completely true and answer 5 means no, that is not true.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Medical Outcomes Study Sleep Scale</measure>
      <time_frame>at 0,4,8 weeks of the study</time_frame>
      <description>sleep quality, score 1-6, base on the statement, answer 1 means all of the time, answer 6 means none of the time</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Revised Fibromyalgia Impact Questionnaire</measure>
      <time_frame>at 0,4,8 weeks of the study</time_frame>
      <description>Fibromyalgia impact, 0-10, answer 0 means no impact, 10 means the most impact</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Medical Outcomes Study Questionnaire Short Form 36</measure>
      <time_frame>at 0,4,8 weeks of the study</time_frame>
      <description>Quality of life measure, answer in descriptive degree of impact to life from: not at all, slightly, moderately, severe, very severe.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Fibromyalgia</condition>
    <arm_group>
      <arm_group_label>Transcutaneous Vagus Nerve Stimulation(tVNS)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>receive tVNS 30 minutes per session, twice/day for 4 weeks</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>receive regular medication treatment without change.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Transcutaneous Vagus Nerve Stimulation</intervention_name>
      <description>30 minutes stimulation, twice per day for 4 weeks</description>
      <arm_group_label>Transcutaneous Vagus Nerve Stimulation(tVNS)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Subject is 18 to 70 years old, including both male and female subjects.&#xD;
  &#xD;
            2. Subject has a documented diagnosis of FM for at least three months. This requirement&#xD;
               is to avoid the uncertainty of an unstable pain condition and to minimize the study&#xD;
               variation.&#xD;
  &#xD;
            3. Subject has a pain score of 4 or above (numeric pain score: 0 - 10 from no pain to&#xD;
               worst pain).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Subject has current cardiac arrhythmia or had implanted cardiac pacemaker or AICD&#xD;
               device.&#xD;
  &#xD;
            2. Subject has major psychiatric disorder required hospitalization in the last 3 months.&#xD;
  &#xD;
            3. Subject has active infection at the site of device application.&#xD;
  &#xD;
            4. Subject has recurrent syncope symptoms within the past three months.&#xD;
  &#xD;
            5. Subject is pregnant.&#xD;
  &#xD;
            6. Subject has had VNS treatment within the past two months.&#xD;
  &#xD;
               .&#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_contact>
      <last_name>Lucy Chen, M.D.</last_name>
      <phone>617-724-3466</phone>
      <email>llchen@mgh.harvard.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jianren Mao, M.D.</last_name>
      <phone>617-726-2338</phone>
      <email>jmao@mgh.harvard.edu</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
      <investigator_full_name>Lucy Chen</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <keyword>Vagus nerve stimulation,</keyword>
    <keyword>pain</keyword>
    <keyword>fibromyalgia symptoms</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fibromyalgia</mesh_term>
      <mesh_term>Myofascial Pain Syndromes</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/NCT06009159
  org study id: 2023P001211
  nct id: NCT06009159
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Fibromyalgia (FM) is a syndrome with clinical symptoms involving multiple systems. The
        efficacy of current treatments is inadequate, and more alternative modalities are needed for
        the management of FM patients. The parasympathetic vagus nerve innervates and integrates
        sensory, motor, and autonomic systems and has been suggested to play a role in pain
        modulation. The role of vagus nerve stimulation (VNS) as a treatment option for FM patients
        is yet to be investigated. The investigators propose to examine the hypothesis that vagus
        nerve stimulation could improve pain and related comorbid symptoms for FM patients.
  The main goal of this study is to generate preliminary data on the effect of VNS on FM
        symptoms. Specifically, the investigators will utilize a recently developed, non-invasive
        method of tVNS (transcutaneous VNS) via auricular branches of vagus nerve (ABVN). The
        investigators plan to conduct an 8-week crossover clinical study with 30 subjects (tVNS vs.
        control; crossover to control vs. tVNS; 4 weeks per period). The primary outcome measure will
        be pain intensity. The secondary outcome measures will be fatigue, sleep, and other
        health-related quality of life measure. These outcome measures will be made at baseline week
        0 (before any intervention), after first 4 weeks of tVNS treatment or control before
        crossover, and at the end of the entire study.
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: 8-week crossover clinical study with 30 subjects (tVNS vs. control; crossover to control vs. tVNS; 4 weeks per period)
  primary purpose: Treatment
  masking: None (Open Label)
  measure: A modified McGill Pain Questionnaire
  time frame: at 0,4,8 weeks of the study,
  description: Pain intensity, 0-10 score, with 0 means no pain and 10 means worst pain
  measure: Multidimensional Fatigue Inventory
  time frame: at 0,4,8 weeks of the study
  description: Fatigue level, 1-5 score, base on the statement, answer 1 means completely true and answer 5 means no, that is not true.
  measure: Medical Outcomes Study Sleep Scale
  time frame: at 0,4,8 weeks of the study
  description: sleep quality, score 1-6, base on the statement, answer 1 means all of the time, answer 6 means none of the time
  measure: Revised Fibromyalgia Impact Questionnaire
  time frame: at 0,4,8 weeks of the study
  description: Fibromyalgia impact, 0-10, answer 0 means no impact, 10 means the most impact
  measure: Medical Outcomes Study Questionnaire Short Form 36
  time frame: at 0,4,8 weeks of the study
  description: Quality of life measure, answer in descriptive degree of impact to life from: not at all, slightly, moderately, severe, very severe.
  arm group label: Transcutaneous Vagus Nerve Stimulation(tVNS)
  arm group type: Experimental
  description: receive tVNS 30 minutes per session, twice/day for 4 weeks
  arm group label: Control group
  arm group type: No Intervention
  description: receive regular medication treatment without change.
  intervention type: Device
  intervention name: Transcutaneous Vagus Nerve Stimulation
  description: 30 minutes stimulation, twice per day for 4 weeks
  arm group label: Transcutaneous Vagus Nerve Stimulation(tVNS)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Lucy Chen, M.D.
  phone: 617-724-3466
  email: llchen@mgh.harvard.edu
  last name: Jianren Mao, M.D.
  phone: 617-726-2338
  email: jmao@mgh.harvard.edu
  responsible party type: Principal Investigator
  investigator affiliation: Massachusetts General Hospital
  investigator full name: Lucy Chen
  investigator title: Associate Professor
  mesh term: Fibromyalgia
  mesh term: Myofascial Pain Syndromes
  sharing ipd: No