<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/NCT03237338</url>
  </required_header>
  <id_info>
    <org_study_id>2017-JYB-JS-166</org_study_id>
    <nct_id>NCT03237338</nct_id>
  </id_info>
  <brief_title>The Study of Mechanism of Chronic Insomnia Disorder Using Acupuncture Based on Changes of Brain GABA and fMRI</brief_title>
  <official_title>The Study of Brain GABA and Brain Functional Modulatory Mechanism of Chronic Insomnia Disorder Using Acupuncture at &quot;Combined Magical-door&quot; Acupoints</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dongfang Hospital Beijing University of Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Xuanwu Hospital, Beijing</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Affiliated Hospital Xi'an Jiaotong University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Dongfang Hospital Beijing University of Chinese Medicine</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>
      Insomnia disorder is one of the major neuropsychiatric diseases which received more attention&#xD;
      in recent years. Disturbances in the amino acid neurotransmitter, gama-amino butyric acid&#xD;
      (GABA) and hyperarousal of cortex are hypothesized to contribute to the neurobiology of&#xD;
      insomnia. Both animal experiment and clinical observation have demonstrated that acupuncture&#xD;
      can generate treatment effect on insomnia symptom. However, the underlying mechanism remains&#xD;
      unclear. The principal objective of this project is to use magnetic resonance spectroscopy&#xD;
      (MRS) as well as acupuncture to provide the first in vivo characterization of cortical GABA&#xD;
      levels between pro- and post-acupuncture treatment in individuals with chronic insomnia&#xD;
      disorder (CID), and use resting state functional magnetic resonance imaging (fMRI) to&#xD;
      determine whether CID patients have altered brain connectivity and network parameter changes.&#xD;
      The investigators are also exploring the correlation between cortical GABA levels, fMRI&#xD;
      parameter changes and abnormalities in sleep parameters and neuropsychology test in CID&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Three groups of subjects (CID accepted true acupuncture, CID accepted sham acupuncture and&#xD;
      healthy) will participate in the study. All subjects will undergo a laboratory blood test,&#xD;
      physical and neurological examination, polysomnography (PSG) and an extensive battery of&#xD;
      neuropsychological assessments. All subjects meeting eligibility criteria for the study will&#xD;
      complete a baseline MRS and fMRI to evaluate differences in multi-modality brain GABA and&#xD;
      fMRI parameters between the patients and healthy. After randomized acupuncture treatment,&#xD;
      investigators will compare brain metabolic and functional parameters to elucidate the neural&#xD;
      mechanism of acupuncture therapy on insomnia, provide theoretical evidence from the&#xD;
      perspective of neurotransmitters and brain network.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 26, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">August 20, 2021</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>Basic Science</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change from baseline brain GABA level at 24 days</measure>
    <time_frame>at the 2 day before acupuncture treatment and the 24th day after acupuncture treatment</time_frame>
    <description>GABA levels in the prefrontal gyrus, occipital gyrus</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>brain functional connectivity</measure>
    <time_frame>at the 24th day after acupuncture treatment</time_frame>
    <description>functional connectivity between the medial prefrontal cortex and other brain regions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wake time after sleep onset (WASO)</measure>
    <time_frame>at the 24th day after acupuncture treatment</time_frame>
    <description>WASO is the total time of awake occurring between sleep onset and final wake up</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Insomnia Disorder</condition>
  <arm_group>
    <arm_group_label>Insomnia-ture acupuncture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>True acupuncture at the &quot;Magical-door&quot;, &quot;Si-shen-cong&quot;, &quot;Shen-ting&quot;, &quot;Local-cave&quot; acupoints will be administered on CID patients Intervention: Procedure: true acupuncture</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Insomnia-sham acupuncture</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham acupuncture at the &quot;Magical-door&quot;, &quot;Si-shen-cong&quot;, &quot;Shen-ting&quot;, &quot;Local-cave&quot; acupoints will be administered on CID patients Intervention: Procedure: true acupuncture</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>ture acupuncture</intervention_name>
    <description>ture acupuncture at the &quot;Magical-door&quot;, &quot;Si-shen-cong&quot;, &quot;Shen-ting&quot;, &quot;Local-cave&quot; acupoints, three times per week and last for 6 weeks</description>
    <arm_group_label>Insomnia-ture acupuncture</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>sham acupuncture</intervention_name>
    <description>Sham acupuncture at the &quot;Magical-door&quot;, &quot;Si-shen-cong&quot;, &quot;Shen-ting&quot;, &quot;Local-cave&quot; acupoints, three times per week and last for 6 weeks</description>
    <arm_group_label>Insomnia-sham acupuncture</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of chronic insomnia disorder (CID) met the criteria of the fifth&#xD;
             edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5)&#xD;
&#xD;
          -  Subject has history of chronic insomnia (difficulty with sleep induction, awakenings&#xD;
             during the night, early morning awakening) of at least 3 months&#xD;
&#xD;
          -  Must be able to cooperate with cognitive testing and MRI scan&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known pre-existing sleep disorder other than chronic insomnia disorder&#xD;
&#xD;
          -  Circadian rhythm sleep disorder determined by sleep-wake cycles of sleep (such as work&#xD;
             time at day and night alternation)&#xD;
&#xD;
          -  Severe general medical disorders of cardiovascular, endocrine, renal, or hepatic&#xD;
             systems&#xD;
&#xD;
          -  Clinical diagnosis of AD or Parkinson's neurodegenerative diseases&#xD;
&#xD;
          -  Moderate or severe psychological illness&#xD;
&#xD;
          -  Clinical history of stroke or other severe cerebrovascular disease&#xD;
&#xD;
          -  Clinical history of malignancies disease&#xD;
&#xD;
          -  Active treatment with antipsychotic medications, benzodiazepines or other hypnotic&#xD;
             agents (i.e. Trazodone, Mirtazapine, Zolpidem, Zaleplon)&#xD;
&#xD;
          -  Alcohol or drug abuse&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ran Pang, doctor</last_name>
    <phone>861067693481</phone>
    <email>pangrandf@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Li Zhang</last_name>
    <phone>861067689644</phone>
    <email>zhanglidf2017@126.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Dongfang Hospital Affiliated to Beijing University of Chinese Medicine</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Li Zhang, MD</last_name>
      <phone>861067689644</phone>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>July 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 2, 2017</study_first_posted>
  <last_update_submitted>July 7, 2021</last_update_submitted>
  <last_update_submitted_qc>July 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Initiation and Maintenance Disorders</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/NCT03237338
org study id: 2017-JYB-JS-166
nct id: NCT03237338
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Insomnia disorder is one of the major neuropsychiatric diseases which received more attention
      in recent years. Disturbances in the amino acid neurotransmitter, gama-amino butyric acid
      (GABA) and hyperarousal of cortex are hypothesized to contribute to the neurobiology of
      insomnia. Both animal experiment and clinical observation have demonstrated that acupuncture
      can generate treatment effect on insomnia symptom. However, the underlying mechanism remains
      unclear. The principal objective of this project is to use magnetic resonance spectroscopy
      (MRS) as well as acupuncture to provide the first in vivo characterization of cortical GABA
      levels between pro- and post-acupuncture treatment in individuals with chronic insomnia
      disorder (CID), and use resting state functional magnetic resonance imaging (fMRI) to
      determine whether CID patients have altered brain connectivity and network parameter changes.
      The investigators are also exploring the correlation between cortical GABA levels, fMRI
      parameter changes and abnormalities in sleep parameters and neuropsychology test in CID
      patients.
Three groups of subjects (CID accepted true acupuncture, CID accepted sham acupuncture and
      healthy) will participate in the study. All subjects will undergo a laboratory blood test,
      physical and neurological examination, polysomnography (PSG) and an extensive battery of
      neuropsychological assessments. All subjects meeting eligibility criteria for the study will
      complete a baseline MRS and fMRI to evaluate differences in multi-modality brain GABA and
      fMRI parameters between the patients and healthy. After randomized acupuncture treatment,
      investigators will compare brain metabolic and functional parameters to elucidate the neural
      mechanism of acupuncture therapy on insomnia, provide theoretical evidence from the
      perspective of neurotransmitters and brain network.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: change from baseline brain GABA level at 24 days
time frame: at the 2 day before acupuncture treatment and the 24th day after acupuncture treatment
description: GABA levels in the prefrontal gyrus, occipital gyrus
measure: brain functional connectivity
time frame: at the 24th day after acupuncture treatment
description: functional connectivity between the medial prefrontal cortex and other brain regions
measure: Wake time after sleep onset (WASO)
time frame: at the 24th day after acupuncture treatment
description: WASO is the total time of awake occurring between sleep onset and final wake up
arm group label: Insomnia-ture acupuncture
arm group type: Experimental
description: True acupuncture at the "Magical-door", "Si-shen-cong", "Shen-ting", "Local-cave" acupoints will be administered on CID patients Intervention: Procedure: true acupuncture
arm group label: Insomnia-sham acupuncture
arm group type: Sham Comparator
description: Sham acupuncture at the "Magical-door", "Si-shen-cong", "Shen-ting", "Local-cave" acupoints will be administered on CID patients Intervention: Procedure: true acupuncture
intervention type: Procedure
intervention name: ture acupuncture
description: ture acupuncture at the "Magical-door", "Si-shen-cong", "Shen-ting", "Local-cave" acupoints, three times per week and last for 6 weeks
arm group label: Insomnia-ture acupuncture
intervention type: Procedure
intervention name: sham acupuncture
description: Sham acupuncture at the "Magical-door", "Si-shen-cong", "Shen-ting", "Local-cave" acupoints, three times per week and last for 6 weeks
arm group label: Insomnia-sham acupuncture
criteria: 
gender: All
minimum age: 25 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ran Pang, doctor
phone: 861067693481
email: pangrandf@163.com
last name: Li Zhang
phone: 861067689644
email: zhanglidf2017@126.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Sleep Initiation and Maintenance Disorders