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/NCT05992285</url>
    </required_header>
    <id_info>
      <org_study_id>20232190</org_study_id>
      <nct_id>NCT05992285</nct_id>
    </id_info>
    <brief_title>A Clinical Study of Theta Burst Stimulation (cTBS) in the Treatment of Insomnia Disorder Targeting the Dentate Nucleus of the Cerebellum</brief_title>
    <official_title>A Clinical Study of Theta Burst Stimulation (cTBS) in the Treatment of Insomnia Disorder Targeting the Dentate Nucleus of the Cerebellum</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Xijing Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Xijing 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>
    </oversight_info>
    <brief_summary>
      <textblock>
        Insomnia disorder (ID) is a significant public health problem worldwide, with nearly a third&#xD;
        of the general population experiencing insomnia symptoms in their lifetime. Therefore,&#xD;
        finding a safe, effective, and easy-to-use non-pharmacological method for treating ID is&#xD;
        urgent. Repetitive transcranial magnetic stimulation (rTMS) has been used to varying degrees&#xD;
        in many neurological and psychiatric diseases and has broad application prospects for&#xD;
        treating ID.θ-burst stimulation is characterized by cluster stimulation.Continuous&#xD;
        stimulation (cTBS) mainly has inhibitory effects on the cortex. The inhibition of&#xD;
        motor-evoked potentials can last for 60 minutes, which is longer-lasting, has a lower&#xD;
        stimulation intensity, and is shorter in duration than traditional rTMS. There are no reports&#xD;
        on clinical studies of cTBS treatment for ID. So far, sleep research has mainly focused on&#xD;
        the interconnections between the neocortex and subcortical structures, while cerebellar&#xD;
        activity has been largely overlooked.The mechanism of rTMS treatment for insomnia with the&#xD;
        cerebellum as the target is unclear. This study proposes to apply cTBS mode to the cerebellar&#xD;
        dentate nucleus for rTMS treatment in patients with ID to explore its effectiveness and&#xD;
        safety in improving insomnia disorder.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 1, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">April 1, 2024</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>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The reduction rate of the Pittsburgh Sleep Quality Index（PSQI） score</measure>
      <time_frame>At the end of 10 days of treatment</time_frame>
      <description>The reduction rate of the Pittsburgh Sleep Quality Index (PSQI) score</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Improvement rate of polysomnography monitoring index</measure>
      <time_frame>At the end of 10 days of treatment and 1 month follow-up</time_frame>
      <description>Improvement rate of polysomnography monitoring index, including total sleep time, fall asleep time, wake time, sleep efficiency, sleep structure, etc.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">68</enrollment>
    <condition>Insomnia Disorder</condition>
    <arm_group>
      <arm_group_label>cTBS group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>the intensity of stimulus was 80% Resting motor threshold (RMT); the frequency of trains was 50 Hz and the number of pulses was three; and the frequency of intertrain intervals was 5 Hz and pulses number was 200. Two groups were repeatedly stimulated in the dentate nucleus of bilateral cerebellum, the interval of each group was 5min, and the number of stimulation pulses at each site was 1200.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>sham group</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>The treatment of the sham group was the same as active group. The only difference was that the coil was flipped 180° in the sham group. The device also made the same sound but could not stimulate the brain.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>transcranial magnetic stimulation</intervention_name>
      <description>the intensity of stimulus was 80% Resting motor threshold(RMT); the frequency of trains was 50 Hz and the number of pulses was three; and the frequency of intertrain intervals was 5 Hz and pulses number was 200. Two groups were repeatedly stimulated in the dentate nucleus of bilateral cerebellum, the interval of each group was 5min, and the number of stimulation pulses at each site was 1200.</description>
      <arm_group_label>cTBS group</arm_group_label>
      <arm_group_label>sham group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All participants aged from 18 to 60 years old; all participants met diagnostic&#xD;
               criteria for insomnia disorder according to the Diagnostic and Statistical Manual of&#xD;
               Mental Disorders-V (DSM-V), and scored &gt;10 on PSQI , ≤14 on the Hamilton Anxiety Scale&#xD;
               (HAMA), and ≤17 on the Hamilton Depression Scale (HAMD); no sleep-affecting drugs were&#xD;
               taken 1 month before or during the trial (non-prescription sleep medication,&#xD;
               benzodiazepines or hypnotics, ect.); patients can cooperate to complete the treatment&#xD;
               and related examination items; all subjects signed informed-consent forms before&#xD;
               enrolling in the trial.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  The patient is unable to cooperate with the completion of treatment and examinations;&#xD;
               there are other types of sleep disorders; a history of psychotropic drug or alcohol&#xD;
               dependence or abuse in the last 2 years; have undertaken trans-meridian travel across&#xD;
               more than two time zones or worked night shifts in the preceding one month or during&#xD;
               the trial period; plan surgical treatment within 1 month before or during the trial;&#xD;
               evidence of neurological or other physical diseases such as respiratory, cardiac,&#xD;
               renal, hepatic, endocrinal diseases and other psychiatric diseases as assessed by&#xD;
               clinical history, physical examination or routine laboratory tests; pregnancy or&#xD;
               breastfeeding women; any contraindication for rTMS (including implanted metal and&#xD;
               devices in the body, and history of epilepsy); concurrent other clinical trials;&#xD;
               patient or family member withdraws informed-consent.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Wen Jiang</last_name>
      <phone>86-13991905538</phone>
      <email>jiangwen@fmmu.edu.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Xinyao Liu</last_name>
      <phone>86-17792252198</phone>
      <email>xuanxuanlxy@163.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Xijing Hospital of Air Force Military Medical University</name>
        <address>
          <city>Xi'an</city>
          <state>Shaanxi</state>
          <zip>710032</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Wen Jiang</last_name>
        <phone>86-13991905538</phone>
        <email>jiangwen@fmmu.edu.cn</email>
      </contact>
      <contact_backup>
        <last_name>Xinyao Liu</last_name>
        <phone>86-17792252198</phone>
        <email>xuanxuanlxy@163.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</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>
    <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/NCT05992285
  org study id: 20232190
  nct id: NCT05992285
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Insomnia disorder (ID) is a significant public health problem worldwide, with nearly a third
        of the general population experiencing insomnia symptoms in their lifetime. Therefore,
        finding a safe, effective, and easy-to-use non-pharmacological method for treating ID is
        urgent. Repetitive transcranial magnetic stimulation (rTMS) has been used to varying degrees
        in many neurological and psychiatric diseases and has broad application prospects for
        treating ID.θ-burst stimulation is characterized by cluster stimulation.Continuous
        stimulation (cTBS) mainly has inhibitory effects on the cortex. The inhibition of
        motor-evoked potentials can last for 60 minutes, which is longer-lasting, has a lower
        stimulation intensity, and is shorter in duration than traditional rTMS. There are no reports
        on clinical studies of cTBS treatment for ID. So far, sleep research has mainly focused on
        the interconnections between the neocortex and subcortical structures, while cerebellar
        activity has been largely overlooked.The mechanism of rTMS treatment for insomnia with the
        cerebellum as the target is unclear. This study proposes to apply cTBS mode to the cerebellar
        dentate nucleus for rTMS treatment in patients with ID to explore its effectiveness and
        safety in improving insomnia disorder.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: The reduction rate of the Pittsburgh Sleep Quality Index（PSQI） score
  time frame: At the end of 10 days of treatment
  description: The reduction rate of the Pittsburgh Sleep Quality Index (PSQI) score
  measure: Improvement rate of polysomnography monitoring index
  time frame: At the end of 10 days of treatment and 1 month follow-up
  description: Improvement rate of polysomnography monitoring index, including total sleep time, fall asleep time, wake time, sleep efficiency, sleep structure, etc.
  arm group label: cTBS group
  arm group type: Experimental
  description: the intensity of stimulus was 80% Resting motor threshold (RMT); the frequency of trains was 50 Hz and the number of pulses was three; and the frequency of intertrain intervals was 5 Hz and pulses number was 200. Two groups were repeatedly stimulated in the dentate nucleus of bilateral cerebellum, the interval of each group was 5min, and the number of stimulation pulses at each site was 1200.
  arm group label: sham group
  arm group type: Sham Comparator
  description: The treatment of the sham group was the same as active group. The only difference was that the coil was flipped 180° in the sham group. The device also made the same sound but could not stimulate the brain.
  intervention type: Device
  intervention name: transcranial magnetic stimulation
  description: the intensity of stimulus was 80% Resting motor threshold(RMT); the frequency of trains was 50 Hz and the number of pulses was three; and the frequency of intertrain intervals was 5 Hz and pulses number was 200. Two groups were repeatedly stimulated in the dentate nucleus of bilateral cerebellum, the interval of each group was 5min, and the number of stimulation pulses at each site was 1200.
  arm group label: cTBS group
  arm group label: sham group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: No
  last name: Wen Jiang
  phone: 86-13991905538
  email: jiangwen@fmmu.edu.cn
  last name: Xinyao Liu
  phone: 86-17792252198
  email: xuanxuanlxy@163.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: China
  responsible party type: Sponsor
  mesh term: Sleep Initiation and Maintenance Disorders
  sharing ipd: No