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/NCT06027190</url>
    </required_header>
    <id_info>
      <org_study_id>2023-160-02</org_study_id>
      <nct_id>NCT06027190</nct_id>
    </id_info>
    <brief_title>Randomized Controlled Study of Optical 3D Navigated Repetitive Transcranial Magnetic Stimulation for Achalasia.</brief_title>
    <official_title>To Investigate the Clinical Efficacy of Optical 3D Navigation Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Achalasia, Optimize the Treatment Parameters, and Provide a Noninvasive Treatment Strategy for Achalasia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Zhang Nina</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School</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>
        The goal of this clinical trial is to investigate the clinical efficacy of repetitive&#xD;
        transcranial magnetic stimulation in the treatment of achalasia in patients diagnosed with&#xD;
        achalasia by comprehensive evaluation of clinical symptoms, HREM, and barium meal&#xD;
        examination, optimize rTMS treatment parameters, and provide an effective and noninvasive new&#xD;
        treatment strategy for achalasia. The main questions it aims to answer are:&#xD;
  &#xD;
          1. To investigate the clinical efficacy of individualized treatment of achalasia with&#xD;
             optical 3D navigation repetitive transcranial magnetic stimulation.&#xD;
  &#xD;
          2. Optimize rTMS parameters to achieve the best clinical treatment.&#xD;
  &#xD;
        Participants will need to fill out the Eckardt score scale and SF-36 quality of life scale,&#xD;
        undergo cranial T1 structural magnetic resonance for functional connectivity analysis, and&#xD;
        select the brain region with the strongest positive functional connectivity to the DMV as the&#xD;
        rTMS target. All patients were randomly divided into four groups: sham-rTMS group, 5Hz-rTMS&#xD;
        group, 10Hz-rTMS group, and 30Hz-rTMS group, and each group received acute and chronic&#xD;
        stimulation, respectively. In the acute stimulation stage, patients only need to do rTMS&#xD;
        once, and HREM and HRV detection are given before and after rTMS (stimulation for 1s,&#xD;
        interval for 4s, 10 pulses per second, receiving a total of 3000 pulses); in the chronic&#xD;
        stimulation stage, patients receive 25 minutes of rTMS actual stimulation or sham stimulation&#xD;
        each time, lasting for 20 times, which is completed within 30 days, and the actual&#xD;
        stimulation parameters are the same as those of acute stimulation, and the sham stimulation&#xD;
        coil is consistent with the appearance and sound of proper stimulation, but there is no&#xD;
        substantial stimulation. High-definition esophageal manometry, timed barium meal, heart rate&#xD;
        coefficient of variation, and serum neurotransmitters were performed before and after chronic&#xD;
        stimulation. Finally, a weekly telephone follow-up was performed for 12 weeks, including&#xD;
        Eckardt score and SF-36 quality of life scale.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Study hypothesis: By analyzing the strongest resting-state functional connectivity between&#xD;
        DMV and right precentral gyrus, left postcentral gyrus, and left brain leads in achalasia&#xD;
        patients, individualized rTMS treatment with optical 3D navigation was applied to relax LES&#xD;
        and relieve the clinical symptoms of dysphagia.&#xD;
  &#xD;
        Statistical methods: SPSS 25.0 software was used to process the data, symptom score,&#xD;
        manometry parameters, serum transmitters and other quantitative indicators. If they met the&#xD;
        normal distribution, they were expressed as Mean ± SD. The t-test was performed for the&#xD;
        comparison between the two groups; if they did not obey the normal distribution, the median&#xD;
        (quartile) was used for statistical description. The rank sum test was used for the&#xD;
        comparison between the two groups. Enumeration data were described using number of cases&#xD;
        (percentage), and X2 test, corrected X2 test, or Fisher exact test were performed for&#xD;
        comparison between the 2 groups.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 1, 2024</start_date>
    <completion_date type="Anticipated">December 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2026</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>
      <intervention_model_description>In patients with achalasia diagnosed by clinical symptoms, HREM and barium meal examination, functional connectivity analysis of DMV with three brain regions (precentral gyrus, postcentral gyrus and insula) was performed by scanning T1 structural magnetic resonance imaging, and brain regions with the strongest positive functional connectivity with DMV were selected as individualized rTMS targets by optical 3D navigation. All patients were randomly divided into four groups: sham-rTMS group, 5Hz-rTMS group, 10Hz-rTMS group, and 30Hz-rTMS group, and each group received acute and chronic stimulation, respectively.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Eckardt score</measure>
      <time_frame>Measured immediately after intervention.</time_frame>
      <description>Achalasia symptom score.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Real-time esophageal barium meal examination</measure>
      <time_frame>Measured immediately after intervention.</time_frame>
      <description>The severity of the patient 's condition and the therapeutic effect were evaluated by defining the height and maximum width of the residual barium area.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>High-resolution esophageal manometry</measure>
      <time_frame>Measured immediately after intervention.</time_frame>
      <description>Esophageal motility evaluation criteria.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Heart rate variability assessment</measure>
      <time_frame>Measured immediately after intervention.</time_frame>
      <description>Dynamic electrocardiogram recording analysis of sympathetic vagal activity.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Neurotransmitter detection analysis</measure>
      <time_frame>Measured immediately after intervention.</time_frame>
      <description>Serum ACh, NO and VIP</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">112</enrollment>
    <condition>Esophageal Achalasia</condition>
    <condition>Transcranial Magnetic Stimulation, Repetitive</condition>
    <condition>Vagus Nerve Motor Disorder</condition>
    <condition>Functional Magnetic Resonance Imaging</condition>
    <arm_group>
      <arm_group_label>Sham group</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>Intervention Name and Specification: Placebo coil (Magstim Company, Whitland, UK): looks and sounds consistent with true coil but does not produce current stimulation.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>rTMS group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>5Hz-rTMS group&#xD;
  10Hz-rTMS group&#xD;
  30Hz-rTMS group&#xD;
  Intervention Name and Specification:&#xD;
  Transcranial magnetic stimulator (M-100 Ultimate, Yingzhi Technology Co., Ltd., China)&#xD;
  70 mm diameter figure-of-eight coil (BY90A, Yingzhi Technology Co., Ltd., China).&#xD;
  Each group received acute and chronic stimulation, respectively. In the acute stimulation stage, patients only needed to do rTMS once, and HREM and HRV were administered before and after rTMS; in the chronic stimulation stage, patients received 25 minutes of rTMS true stimulation each time a day for 20 times, which was completed within 30 days, and the true stimulation parameters were the same as those of acute stimulation.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Repetitive transcranial magnetic stimulation</intervention_name>
      <description>Intervention Name and Specification&#xD;
  Transcranial magnetic stimulator (M-100 Ultimate, Yingzhi Technology Co., Ltd., China) .&#xD;
  70-mm-diameter figure-of-eight coil (BY90A, Yingzhi Technology Co., Ltd., China). 3) Placebo coil (Magstim Company, Whitland, UK): the appearance and sound were consistent with the true coil, but no current stimulation was produced.</description>
      <arm_group_label>rTMS group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Sham</intervention_name>
      <description>Placebo coil (Magstim Company, Whitland, UK):</description>
      <arm_group_label>Sham group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  (1) Aged more than 18 years old, less than 75 years old; (2) Clinical symptoms&#xD;
               evaluation, HREM, esophageal barium meal examination confirmed the diagnosis of&#xD;
               achalasia; (3) Willing to sign informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  (1) Presence of metal hardware in close contact with the discharge coil (e.g.,&#xD;
               cochlear implant, internal pulse generator, or drug pump). Note: Cochlear implants&#xD;
               include electrodes, magnets, loop antennas, and electronic chips under the scalp&#xD;
               implanted in the cochlea; (2) Intracranial metal implants; (3) Patients with cardiac&#xD;
               pacemakers, vagal nerve stimulation (VNS) systems, spinal cord stimulators, and deep&#xD;
               brain stimulation implanted with pulse generators should be used with caution; (4)&#xD;
               People at higher risk of noisy hearing loss and patients with hypoacusis symptoms&#xD;
               should be used with caution; (5) Pregnancy; (6) Severe or recent heart disease; (7)&#xD;
               Personal history of epilepsy, use of known drugs that lower the seizure threshold, and&#xD;
               other factors that may lower the seizure threshold (e.g., lack of sleep, infection,&#xD;
               and alcohol abuse); (8) Increased intracranial pressure; (9) Acute phase of&#xD;
               intracranial infection and hemorrhagic disease; (10) Contraindications to MRI&#xD;
               examination or claustrophobia; (11) Refusal to sign informed consent.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Nina Zhang</last_name>
      <phone>18652782446</phone>
      <email>zhangnina@njglyy.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Xinyi Lu</last_name>
      <phone>17365386771</phone>
      <email>luxinyi0809@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Nanjing Drum Tower Hospital</name>
        <address>
          <city>Nanjing</city>
          <zip>210008</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Nina Zhang</last_name>
        <phone>+8618652782446</phone>
        <email>zhangnina@njglyy.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <reference>
      <citation>Pomenti S, Blackett JW, Jodorkovsky D. Achalasia: Diagnosis, Management and Surveillance. Gastroenterol Clin North Am. 2021 Dec;50(4):721-736. doi: 10.1016/j.gtc.2021.07.001. Epub 2021 Oct 2.</citation>
      <PMID>34717867</PMID>
    </reference>
    <reference>
      <citation>Schlottmann F, Patti MG. Esophageal achalasia: current diagnosis and treatment. Expert Rev Gastroenterol Hepatol. 2018 Jul;12(7):711-721. doi: 10.1080/17474124.2018.1481748. Epub 2018 Jun 8.</citation>
      <PMID>29804476</PMID>
    </reference>
    <reference>
      <citation>Mari A, Abu Baker F, Pellicano R, Khoury T. Diagnosis and Management of Achalasia: Updates of the Last Two Years. J Clin Med. 2021 Aug 16;10(16):3607. doi: 10.3390/jcm10163607.</citation>
      <PMID>34441901</PMID>
    </reference>
    <reference>
      <citation>Gregersen H, Lo KM. Pathophysiology and treatment of achalasia in a muscle mechanical perspective. Ann N Y Acad Sci. 2018 Dec;1434(1):173-184. doi: 10.1111/nyas.13711. Epub 2018 May 14.</citation>
      <PMID>29756656</PMID>
    </reference>
    <reference>
      <citation>Shiwaku H, Sato H, Shimamura Y, Abe H, Shiota J, Sato C, Ominami M, Sakae H, Hata Y, Fukuda H, Ogawa R, Nakamura J, Tatsuta T, Ikebuchi Y, Yokomichi H, Hasegawa S, Inoue H. Risk factors and long-term course of gastroesophageal reflux disease after peroral endoscopic myotomy: A large-scale multicenter cohort study in Japan. Endoscopy. 2022 Sep;54(9):839-847. doi: 10.1055/a-1753-9801. Epub 2022 Feb 16. Erratum In: Endoscopy. 2022 Mar 01;:</citation>
      <PMID>35172368</PMID>
    </reference>
    <reference>
      <citation>Schlottmann F, Neto RML, Herbella FAM, Patti MG. Esophageal Achalasia: Pathophysiology, Clinical Presentation, and Diagnostic Evaluation. Am Surg. 2018 Apr 1;84(4):467-472.</citation>
      <PMID>29712590</PMID>
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      <citation>Goyal RK, Padmanabhan R, Sang Q. Neural circuits in swallowing and abdominal vagal afferent-mediated lower esophageal sphincter relaxation. Am J Med. 2001 Dec 3;111 Suppl 8A:95S-105S. doi: 10.1016/s0002-9343(01)00863-4.</citation>
      <PMID>11749933</PMID>
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      <citation>Clyburn C, Travagli RA, Browning KN. Acute high-fat diet upregulates glutamatergic signaling in the dorsal motor nucleus of the vagus. Am J Physiol Gastrointest Liver Physiol. 2018 May 1;314(5):G623-G634. doi: 10.1152/ajpgi.00395.2017. Epub 2018 Jan 25.</citation>
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      <citation>Browning KN, Carson KE. Central Neurocircuits Regulating Food Intake in Response to Gut Inputs-Preclinical Evidence. Nutrients. 2021 Mar 11;13(3):908. doi: 10.3390/nu13030908.</citation>
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      <citation>Farre R, Sifrim D. Regulation of basal tone, relaxation and contraction of the lower oesophageal sphincter. Relevance to drug discovery for oesophageal disorders. Br J Pharmacol. 2008 Mar;153(5):858-69. doi: 10.1038/sj.bjp.0707572. Epub 2007 Nov 12.</citation>
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      <citation>Abrahams TP, Partosoedarso ER, Hornby PJ. Lower oesophageal sphincter relaxation evoked by stimulation of the dorsal motor nucleus of the vagus in ferrets. Neurogastroenterol Motil. 2002 Jun;14(3):295-304. doi: 10.1046/j.1365-2982.2002.00329.x.</citation>
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      <citation>Roth BL. DREADDs for Neuroscientists. Neuron. 2016 Feb 17;89(4):683-94. doi: 10.1016/j.neuron.2016.01.040.</citation>
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      <citation>Nagai Y, Miyakawa N, Takuwa H, Hori Y, Oyama K, Ji B, Takahashi M, Huang XP, Slocum ST, DiBerto JF, Xiong Y, Urushihata T, Hirabayashi T, Fujimoto A, Mimura K, English JG, Liu J, Inoue KI, Kumata K, Seki C, Ono M, Shimojo M, Zhang MR, Tomita Y, Nakahara J, Suhara T, Takada M, Higuchi M, Jin J, Roth BL, Minamimoto T. Deschloroclozapine, a potent and selective chemogenetic actuator enables rapid neuronal and behavioral modulations in mice and monkeys. Nat Neurosci. 2020 Sep;23(9):1157-1167. doi: 10.1038/s41593-020-0661-3. Epub 2020 Jul 6.</citation>
      <PMID>32632286</PMID>
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      <citation>Travagli RA, Anselmi L. Vagal neurocircuitry and its influence on gastric motility. Nat Rev Gastroenterol Hepatol. 2016 Jul;13(7):389-401. doi: 10.1038/nrgastro.2016.76. Epub 2016 May 25.</citation>
      <PMID>27251213</PMID>
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      <citation>Li J, Xu K, Guo Y, Chen X, Li G, Qi L, Che X. Case evidence of repetitive transcranial magnetic stimulation in the management of refractory irritable bowel syndrome with comorbid depression. Brain Stimul. 2022 Mar-Apr;15(2):434-436. doi: 10.1016/j.brs.2022.01.020. Epub 2022 Feb 11. No abstract available.</citation>
      <PMID>35158109</PMID>
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      <citation>Algladi T, Harris M, Whorwell PJ, Paine P, Hamdy S. Modulation of human visceral sensitivity by noninvasive magnetoelectrical neural stimulation in health and irritable bowel syndrome. Pain. 2015 Jul;156(7):1348-1356. doi: 10.1097/j.pain.0000000000000187.</citation>
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    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School</investigator_affiliation>
      <investigator_full_name>Zhang Nina</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Achalasia</keyword>
    <keyword>rTMS</keyword>
    <keyword>fMRI</keyword>
    <keyword>Non-invasive</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Esophageal Achalasia</mesh_term>
      <mesh_term>Vagus Nerve Diseases</mesh_term>
      <mesh_term>Motor Disorders</mesh_term>
    </condition_browse>
    <!-- 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/NCT06027190
  org study id: 2023-160-02
  nct id: NCT06027190
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to investigate the clinical efficacy of repetitive
        transcranial magnetic stimulation in the treatment of achalasia in patients diagnosed with
        achalasia by comprehensive evaluation of clinical symptoms, HREM, and barium meal
        examination, optimize rTMS treatment parameters, and provide an effective and noninvasive new
        treatment strategy for achalasia. The main questions it aims to answer are:
  
          1. To investigate the clinical efficacy of individualized treatment of achalasia with
             optical 3D navigation repetitive transcranial magnetic stimulation.
  
          2. Optimize rTMS parameters to achieve the best clinical treatment.
  
        Participants will need to fill out the Eckardt score scale and SF-36 quality of life scale,
        undergo cranial T1 structural magnetic resonance for functional connectivity analysis, and
        select the brain region with the strongest positive functional connectivity to the DMV as the
        rTMS target. All patients were randomly divided into four groups: sham-rTMS group, 5Hz-rTMS
        group, 10Hz-rTMS group, and 30Hz-rTMS group, and each group received acute and chronic
        stimulation, respectively. In the acute stimulation stage, patients only need to do rTMS
        once, and HREM and HRV detection are given before and after rTMS (stimulation for 1s,
        interval for 4s, 10 pulses per second, receiving a total of 3000 pulses); in the chronic
        stimulation stage, patients receive 25 minutes of rTMS actual stimulation or sham stimulation
        each time, lasting for 20 times, which is completed within 30 days, and the actual
        stimulation parameters are the same as those of acute stimulation, and the sham stimulation
        coil is consistent with the appearance and sound of proper stimulation, but there is no
        substantial stimulation. High-definition esophageal manometry, timed barium meal, heart rate
        coefficient of variation, and serum neurotransmitters were performed before and after chronic
        stimulation. Finally, a weekly telephone follow-up was performed for 12 weeks, including
        Eckardt score and SF-36 quality of life scale.
  Study hypothesis: By analyzing the strongest resting-state functional connectivity between
        DMV and right precentral gyrus, left postcentral gyrus, and left brain leads in achalasia
        patients, individualized rTMS treatment with optical 3D navigation was applied to relax LES
        and relieve the clinical symptoms of dysphagia.
  
        Statistical methods: SPSS 25.0 software was used to process the data, symptom score,
        manometry parameters, serum transmitters and other quantitative indicators. If they met the
        normal distribution, they were expressed as Mean ± SD. The t-test was performed for the
        comparison between the two groups; if they did not obey the normal distribution, the median
        (quartile) was used for statistical description. The rank sum test was used for the
        comparison between the two groups. Enumeration data were described using number of cases
        (percentage), and X2 test, corrected X2 test, or Fisher exact test were performed for
        comparison between the 2 groups.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: In patients with achalasia diagnosed by clinical symptoms, HREM and barium meal examination, functional connectivity analysis of DMV with three brain regions (precentral gyrus, postcentral gyrus and insula) was performed by scanning T1 structural magnetic resonance imaging, and brain regions with the strongest positive functional connectivity with DMV were selected as individualized rTMS targets by optical 3D navigation. All patients were randomly divided into four groups: sham-rTMS group, 5Hz-rTMS group, 10Hz-rTMS group, and 30Hz-rTMS group, and each group received acute and chronic stimulation, respectively.
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Eckardt score
  time frame: Measured immediately after intervention.
  description: Achalasia symptom score.
  measure: Real-time esophageal barium meal examination
  time frame: Measured immediately after intervention.
  description: The severity of the patient 's condition and the therapeutic effect were evaluated by defining the height and maximum width of the residual barium area.
  measure: High-resolution esophageal manometry
  time frame: Measured immediately after intervention.
  description: Esophageal motility evaluation criteria.
  measure: Heart rate variability assessment
  time frame: Measured immediately after intervention.
  description: Dynamic electrocardiogram recording analysis of sympathetic vagal activity.
  measure: Neurotransmitter detection analysis
  time frame: Measured immediately after intervention.
  description: Serum ACh, NO and VIP
  arm group label: Sham group
  arm group type: Sham Comparator
  description: Intervention Name and Specification: Placebo coil (Magstim Company, Whitland, UK): looks and sounds consistent with true coil but does not produce current stimulation.
  arm group label: rTMS group
  arm group type: Experimental
  description: 5Hz-rTMS group
  10Hz-rTMS group
  30Hz-rTMS group
  Intervention Name and Specification:
  Transcranial magnetic stimulator (M-100 Ultimate, Yingzhi Technology Co., Ltd., China)
  70 mm diameter figure-of-eight coil (BY90A, Yingzhi Technology Co., Ltd., China).
  Each group received acute and chronic stimulation, respectively. In the acute stimulation stage, patients only needed to do rTMS once, and HREM and HRV were administered before and after rTMS; in the chronic stimulation stage, patients received 25 minutes of rTMS true stimulation each time a day for 20 times, which was completed within 30 days, and the true stimulation parameters were the same as those of acute stimulation.
  intervention type: Device
  intervention name: Repetitive transcranial magnetic stimulation
  description: Intervention Name and Specification
  Transcranial magnetic stimulator (M-100 Ultimate, Yingzhi Technology Co., Ltd., China) .
  70-mm-diameter figure-of-eight coil (BY90A, Yingzhi Technology Co., Ltd., China). 3) Placebo coil (Magstim Company, Whitland, UK): the appearance and sound were consistent with the true coil, but no current stimulation was produced.
  arm group label: rTMS group
  intervention type: Device
  intervention name: Sham
  description: Placebo coil (Magstim Company, Whitland, UK):
  arm group label: Sham group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Nina Zhang
  phone: 18652782446
  email: zhangnina@njglyy.com
  last name: Xinyi Lu
  phone: 17365386771
  email: luxinyi0809@gmail.com
  facility: 
  contact: 
  country: China
  citation: Pomenti S, Blackett JW, Jodorkovsky D. Achalasia: Diagnosis, Management and Surveillance. Gastroenterol Clin North Am. 2021 Dec;50(4):721-736. doi: 10.1016/j.gtc.2021.07.001. Epub 2021 Oct 2.
  PMID: 34717867
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  responsible party type: Sponsor-Investigator
  investigator affiliation: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
  investigator full name: Zhang Nina
  investigator title: Professor
  mesh term: Esophageal Achalasia
  mesh term: Vagus Nerve Diseases
  mesh term: Motor Disorders