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/NCT06026826</url>
    </required_header>
    <id_info>
      <org_study_id>AHMU-tACS-anxiety</org_study_id>
      <nct_id>NCT06026826</nct_id>
    </id_info>
    <brief_title>Intervention Effect of Transcranial Alternating Current Stimulation(tACS) on Anxiety Disorder</brief_title>
    <official_title>Intervention Effect of Transcranial Alternating Current Stimulation(tACS) on Anxiety Disorder</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Anhui Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Anhui Medical University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        To investigate the intervention effect of transcranial alternating current stimulation(tACS)&#xD;
        on anxiety symptoms and somatic symptoms in patients with anxiety disorder and its underlying&#xD;
        neural mechanism by MRI.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Forty patients with anxiety disorder diagnosed by DSM-5 were recruited from the second&#xD;
        affiliated Hospital of Anhui Medical University. All participants underwent a structured&#xD;
        interview and routine laboratory examination before and after receiving tACS. After meeting&#xD;
        the inclusion criteria and obtaining informed consent, each participant will complete the&#xD;
        clinical evaluation, functional magnetic resonance imaging (fMRI) and tACS treatment&#xD;
        conducted by trained researchers at the Neuropsychological Synergetic Innovation Center of&#xD;
        Anhui Medical University. All the participants were randomized (1:1) to receive &quot;active&quot; or&#xD;
        &quot;sham&quot; treatment protocol. The anode was placed over AF3 with return electrodes placed at the&#xD;
        contralateral mastoid process. Fourteen 2-mA sessions (ramp-up and ramp-down periods of 30&#xD;
        and 30 seconds, respectively) were applied for 20 minutes per session, twice daily over 7&#xD;
        consecutive days, and the stimulus frequency was set as 8 Hz. Sham tACS was delivered using&#xD;
        the same protocol and current intensity, but the period of active stimulation was only during&#xD;
        the ramp-up and ramp-down periods of 30 and 30 seconds.&#xD;
  &#xD;
        Before and after the tACS treatment, the patients had receiving a battery measure of&#xD;
        neuropsychological tests and Magnetic resonance imaging scan in multimodalities.&#xD;
        Neuropsychological assessment included HAMD, HAMA, PHQ15, ISI, ASI, SAS, RRS, IUS. Multimodal&#xD;
        fMRI includes 3D-T1, rs-fMRI and DTI.&#xD;
  &#xD;
        Neuropsychological evaluation and magnetic resonance imaging data were obtained again 24&#xD;
        hours after the last treatment. The symptoms of the patients were followed up one month after&#xD;
        the end of treatment.They were instructed to focus their answers on the past week.&#xD;
        Afterwards, they were unblinded by the study coordinator.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">November 1, 2022</start_date>
    <completion_date type="Anticipated">July 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 31, 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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>anxiety symptoms</measure>
      <time_frame>baseline and immediately after intervention</time_frame>
      <description>the change of anxiety symptoms assessed by HAMA scale(Hamilton Anxiety Scale) will constitute the major research outcome measure, to assess response to dDCS. HAMA scale scores range from 0 to 56 points, the higher the score indicates the more serious anxiety symptoms</description>
    </primary_outcome>
    <primary_outcome>
      <measure>resting-state functional connectivity</measure>
      <time_frame>baseline and immediately after intervention</time_frame>
      <description>the change of resting-state functional connectivity strength between stimulated target and the whole brain areas will be measured by functional MRI.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>somatic symptoms</measure>
      <time_frame>baseline and immediately after intervention</time_frame>
      <description>the change of somatic symptoms will be assessed by Patient Health Questionnaire (PHQ-15). PHQ-15 is composed of 15 physical symptoms that have been extracted from the PHQ. PHQ-15 scale scores range from 0 to 30 points. Higher scores indicate more severe somatic symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>SAS(Self-rating anxiety scale)</measure>
      <time_frame>baseline and immediately after intervention</time_frame>
      <description>Self-rating anxiety scale(SAS) is a supplementary evaluation of the change of anxiety state of patients in this experiment, and it also belongs to the category of self-rating scale. Patients assessed anxiety by checking the frequency of 20 items: none or almost none, sometimes, most of the time, most of the time, or all of the time. SAS scale scores range from 0 to 100 points。The higher the score, the more serious the anxiety symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>ISI(The insomnia severity index)</measure>
      <time_frame>baseline and immediately after intervention</time_frame>
      <description>ISI(The insomnia severity index) is used to evaluate the changes of sleep status of anxiety patients in the recent (2 weeks), which is a self-rating scale. ISI scale scores range from 0 to 28 points. The higher the score is, the worse the sleep quality is. This scale indirectly reflects the changes of patients' anxiety state through evaluation.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Transcranial Alternating Current Stimulation</condition>
    <condition>Anxiety Disorder</condition>
    <condition>Magnetic Resonance Imaging</condition>
    <arm_group>
      <arm_group_label>real stimulation</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants will receive active tACS twice daily for one week. The anode was placed over AF3 with return electrodes placed at the contralateral mastoid process. Fourteen 2-mA sessions (ramp-up and ramp-down periods of 30 and 30 seconds, respectively) were applied for 20 minutes per session, twice daily over 7 consecutive days, and the stimulus frequency was set as 8 Hz.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>sham stimulation</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>Participants will receive sham tACS twice daily for one week. Sham tACS was delivered using the same protocol and current intensity, but the period of active stimulation was only during the ramp-up and ramp-down periods of 30 and 30 seconds.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>transcranial alternating current stimulation</intervention_name>
      <description>tACS is described as a non-invasive form of brain stimulation that uses a low-intensity, alternating current applied directly to the head through scalp electrodes.</description>
      <arm_group_label>real stimulation</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>sham transcranial alternating current stimulation</intervention_name>
      <description>Sham tACS was delivered using the same protocol and current intensity, but the period of active stimulation was only during the ramp-up and ramp-down periods of 30 and 30 seconds.</description>
      <arm_group_label>sham stimulation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  the patients were diagnosed by more than 2 psychiatrists and met the diagnostic&#xD;
               criteria of DSM-5 for anxiety, and HAMA&gt;14, PHQ-15&gt;5.&#xD;
  &#xD;
          the age ranged from 18 to 60 years old, and the length of education was more than 5 years.&#xD;
  &#xD;
          the visual acuity or corrected visual acuity is normal, right-handed, can cooperate with&#xD;
          the completion of various experimental tests.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  accompanied by severe somatic diseases, such as severe heart, liver, renal&#xD;
               insufficiency and so on.&#xD;
  &#xD;
          accompanied by other neurological diseases, such as stroke, epilepsy and so on. pregnant&#xD;
          and lactating women. accompanied by other mental disorders, such as drug abuse,&#xD;
          schizophrenia, schizophrenic affective disorder, hysteria, autism and so on.&#xD;
  &#xD;
          patients with MRI taboos or factors affecting imaging quality, such as cardiac pacemaker,&#xD;
          cochlear implant, cardio-cerebrovascular metal stent, metal denture, etc.&#xD;
  &#xD;
          those who could not cooperate with those who completed the relevant experiments, such as&#xD;
          patients with depressive stupor, claustrophobia and so on.&#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>Wang Kai, PhD</last_name>
      <phone>+86-0551-62923704</phone>
      <email>wangkai1964@126.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Tongjian Bai</last_name>
      <phone>+8615256972606</phone>
      <email>baiyunong1990@163.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Anhui Medical University</name>
        <address>
          <city>Hefei</city>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Tongjian Bai</last_name>
        <email>ahmubtj1990@126.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Anhui Medical University</investigator_affiliation>
      <investigator_full_name>WANG KAI</investigator_full_name>
      <investigator_title>Director of medical psychological department, Anhui Medical University</investigator_title>
    </responsible_party>
    <keyword>Transcranial Alternating Current Stimulation</keyword>
    <keyword>Anxiety Disorder</keyword>
    <keyword>Magnetic Resonance Imaging</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Anxiety 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/NCT06026826
  org study id: AHMU-tACS-anxiety
  nct id: NCT06026826
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  To investigate the intervention effect of transcranial alternating current stimulation(tACS)
        on anxiety symptoms and somatic symptoms in patients with anxiety disorder and its underlying
        neural mechanism by MRI.
  Forty patients with anxiety disorder diagnosed by DSM-5 were recruited from the second
        affiliated Hospital of Anhui Medical University. All participants underwent a structured
        interview and routine laboratory examination before and after receiving tACS. After meeting
        the inclusion criteria and obtaining informed consent, each participant will complete the
        clinical evaluation, functional magnetic resonance imaging (fMRI) and tACS treatment
        conducted by trained researchers at the Neuropsychological Synergetic Innovation Center of
        Anhui Medical University. All the participants were randomized (1:1) to receive "active" or
        "sham" treatment protocol. The anode was placed over AF3 with return electrodes placed at the
        contralateral mastoid process. Fourteen 2-mA sessions (ramp-up and ramp-down periods of 30
        and 30 seconds, respectively) were applied for 20 minutes per session, twice daily over 7
        consecutive days, and the stimulus frequency was set as 8 Hz. Sham tACS was delivered using
        the same protocol and current intensity, but the period of active stimulation was only during
        the ramp-up and ramp-down periods of 30 and 30 seconds.
  
        Before and after the tACS treatment, the patients had receiving a battery measure of
        neuropsychological tests and Magnetic resonance imaging scan in multimodalities.
        Neuropsychological assessment included HAMD, HAMA, PHQ15, ISI, ASI, SAS, RRS, IUS. Multimodal
        fMRI includes 3D-T1, rs-fMRI and DTI.
  
        Neuropsychological evaluation and magnetic resonance imaging data were obtained again 24
        hours after the last treatment. The symptoms of the patients were followed up one month after
        the end of treatment.They were instructed to focus their answers on the past week.
        Afterwards, they were unblinded by the study coordinator.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: anxiety symptoms
  time frame: baseline and immediately after intervention
  description: the change of anxiety symptoms assessed by HAMA scale(Hamilton Anxiety Scale) will constitute the major research outcome measure, to assess response to dDCS. HAMA scale scores range from 0 to 56 points, the higher the score indicates the more serious anxiety symptoms
  measure: resting-state functional connectivity
  time frame: baseline and immediately after intervention
  description: the change of resting-state functional connectivity strength between stimulated target and the whole brain areas will be measured by functional MRI.
  measure: somatic symptoms
  time frame: baseline and immediately after intervention
  description: the change of somatic symptoms will be assessed by Patient Health Questionnaire (PHQ-15). PHQ-15 is composed of 15 physical symptoms that have been extracted from the PHQ. PHQ-15 scale scores range from 0 to 30 points. Higher scores indicate more severe somatic symptoms.
  measure: SAS(Self-rating anxiety scale)
  time frame: baseline and immediately after intervention
  description: Self-rating anxiety scale(SAS) is a supplementary evaluation of the change of anxiety state of patients in this experiment, and it also belongs to the category of self-rating scale. Patients assessed anxiety by checking the frequency of 20 items: none or almost none, sometimes, most of the time, most of the time, or all of the time. SAS scale scores range from 0 to 100 points。The higher the score, the more serious the anxiety symptoms.
  measure: ISI(The insomnia severity index)
  time frame: baseline and immediately after intervention
  description: ISI(The insomnia severity index) is used to evaluate the changes of sleep status of anxiety patients in the recent (2 weeks), which is a self-rating scale. ISI scale scores range from 0 to 28 points. The higher the score is, the worse the sleep quality is. This scale indirectly reflects the changes of patients' anxiety state through evaluation.
  arm group label: real stimulation
  arm group type: Active Comparator
  description: Participants will receive active tACS twice daily for one week. The anode was placed over AF3 with return electrodes placed at the contralateral mastoid process. Fourteen 2-mA sessions (ramp-up and ramp-down periods of 30 and 30 seconds, respectively) were applied for 20 minutes per session, twice daily over 7 consecutive days, and the stimulus frequency was set as 8 Hz.
  arm group label: sham stimulation
  arm group type: Sham Comparator
  description: Participants will receive sham tACS twice daily for one week. Sham tACS was delivered using the same protocol and current intensity, but the period of active stimulation was only during the ramp-up and ramp-down periods of 30 and 30 seconds.
  intervention type: Device
  intervention name: transcranial alternating current stimulation
  description: tACS is described as a non-invasive form of brain stimulation that uses a low-intensity, alternating current applied directly to the head through scalp electrodes.
  arm group label: real stimulation
  intervention type: Device
  intervention name: sham transcranial alternating current stimulation
  description: Sham tACS was delivered using the same protocol and current intensity, but the period of active stimulation was only during the ramp-up and ramp-down periods of 30 and 30 seconds.
  arm group label: sham stimulation
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: No
  last name: Wang Kai, PhD
  phone: +86-0551-62923704
  email: wangkai1964@126.com
  last name: Tongjian Bai
  phone: +8615256972606
  email: baiyunong1990@163.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Anhui Medical University
  investigator full name: WANG KAI
  investigator title: Director of medical psychological department, Anhui Medical University
  mesh term: Anxiety Disorders