<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/NCT04426773</url>
  </required_header>
  <id_info>
    <org_study_id>SMHC-OCD-006</org_study_id>
    <nct_id>NCT04426773</nct_id>
  </id_info>
  <brief_title>Electroencephalography (EEG) Predictors of Transcranial Direct Current Stimulation (tDCS) in Obsessive-Compulsive Disorder (OCD)</brief_title>
  <official_title>Electroencephalography (EEG) Predictors of Response to Transcranial Direct Current Stimulation (tDCS) Treating Obsessive-Compulsive Disorder (OCD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Mental Health Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Mental Health Center</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>
      This study is designed to find Electroencephalogram (EEG) biomarkers to predict transcranial&#xD;
      direct current stimulation (tDCS) response in obsessive-compulsive disorder.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to explore resting state electroencephalography and transcranial&#xD;
      magnetic stimulation and electroencephalography (TMS-EEG) biomarkers that would predict&#xD;
      transcranial direct current stimulation (tDCS) response in obsessive-compulsive disorder with&#xD;
      cathode electrode targeting orbitofrontal cortex (OFC). 30 OCD patients will be recruited to&#xD;
      this study and performed once a day, five times a week direct current stimulation treatment&#xD;
      for two weeks. The investigators will assess symptom severity before and after two weeks of&#xD;
      tDCS. Through the study, Yale-Brown Obsessive Compulsive Scale（Y-BOCS）, the Obsessive&#xD;
      Compulsive Inventory-Revised (OCI-R), the Beck Depression Inventory(BDI), Pittsburgh sleep&#xD;
      quality index (PSQI)and side-effect questionnaire will be obtained by a trained investigator.&#xD;
      Resting state electroencephalography and TMS-EEG testing will be conducted before and after&#xD;
      tDCS treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">April 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in symptom improvement assessed by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>It assesses the severity of OCD symptoms. The Y-BOCS scale ranges from 0 to 40, with 0 being no symptoms and 40 being severe.The responder on Y-BOCS is defined as a Y-BOCS decrease at least 35% from the baseline at post-treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in long-interval intracortical inhibition (LICI) and short interval intracortical inhibition (SICI) measured by TMS-EEG</measure>
    <time_frame>Up to 2 weeks</time_frame>
    <description>LICI and SICI are TMS-EEG paradigm to assess the extent of cortical inhibition. LICI and SICI will be measured using single and paired TMS pulses applied to the OFC. LICI and SICI will be compared between before and after treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>EEG biomarkers as predictors of response to tDCS</measure>
    <time_frame>baseline</time_frame>
    <description>LICI and SICI measured by TMS-EEG and resting state EEG will be performed to investigate predictors of response to tDCS in OCD patients.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Obsessive Compulsive Inventory-Revised(OCI-R)</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>It is an inventory of OCD symptoms with 18 items that are rated on a 5-point Likert scale. Total scores range from 0 to 72, with higher scores indicating more severe OCD symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in The Beck Depression Inventory(BDI)</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>It consists of 21 items and uses a 0 to 3 severity scale. Total scores range from 0 to 63, with higher scores indicating more severe depression symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in The Beck Anxiety Inventory (BAI)</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>It is an inventory of anxiety symptoms with 18 items that are rated on a 5-point Likert scale(0 to 4). Total scores range from 0 to 72, with higher scores indicating more severe anxiety symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Pittsburgh sleep quality index(PSQI)</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>The Pittsburgh Sleep Quality Index (PSQI) contains 19 self-rated questions which measures seven aspects of sleep: (1) subjective sleep quality, (2) sleep latency, (3) sleep duration, (4) habitual sleep efficiency, (5) sleep disturbances, (6) use of sleeping medication, and (7) daytime dysfunction. The 19 self-rated items are combined to form seven component scores, each of which has a range of 0-3 points (0 indicates no difficulty, while 3 indicates severe difficulty). The seven component scores are then summed to yield one global score, with a range of 0-21 points (0 indicating no difficulty, and 21 indicating severe difficulties in all the seven areas of sleep quality).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Side-effect questionnaire</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>It consists of 10-item and uses 0 to 3 severity scale to rate the intensity of side effects. Total scores range from 0 to 30, with higher scores indicating more severe side-effect. It also assesses the relation between side-effect and the effects of tDCS using 0 to 4 scale. Total scores range from 0 to 40, with higher score indicating the greater relation.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Obsessive-Compulsive Disorder</condition>
  <arm_group>
    <arm_group_label>tDCS treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cathode transcranial direct current stimulation over the right OFC will be applied once a day, 5 days a week, for 2 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>High-Definition transcranial direct current stimulation</intervention_name>
    <description>The tDCS device will deliver a direct current of 1.5mA for 20 minutes. Cathode electrode will be localized in front of the OFC on the Fp2 point according to the EEG international reference. Four anode electrodes will be placed around FP2 (i.e. Fpz, AFz, AF4, AF8).</description>
    <arm_group_label>tDCS treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age: 18-50 years old;&#xD;
&#xD;
          -  DSM-5 criteria for OCD;&#xD;
&#xD;
          -  Y-BOCS total score &gt; or = 16&#xD;
&#xD;
          -  &gt;or＝9 years education&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any additional current psychiatric comorbidity&#xD;
&#xD;
          -  The inability to receive tDCS because of metallic implants, or history of&#xD;
             seizures，history of head injury, or history of neurosurgery.&#xD;
&#xD;
          -  Participants with claustrophobic, heart pacemaker, mechanical heart valve, mechanical&#xD;
             implant such as an aneurysm clip, hip replacement, or any other pieces of metal that&#xD;
             have accidentally entered their body.&#xD;
&#xD;
          -  Any current significant medical condition.&#xD;
&#xD;
          -  serious suicide risk&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zhen Wang, PhD,MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai Mental Health Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Zhen Wang</last_name>
    <phone>+86 34773516</phone>
    <email>wangzhen@smhc.org.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Zhen Wang</last_name>
    <phone>+86 64387250</phone>
    <email>wangzhen@smhc.org.cn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Shanghai Mental Health Center</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200030</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhen Wang</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>September 7, 2022</last_update_submitted>
  <last_update_submitted_qc>September 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Mental Health Center</investigator_affiliation>
    <investigator_full_name>Zhen Wang</investigator_full_name>
    <investigator_title>vice-president</investigator_title>
  </responsible_party>
  <keyword>transcranial direct current stimulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Compulsive Personality Disorder</mesh_term>
    <mesh_term>Obsessive-Compulsive Disorder</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/NCT04426773
org study id: SMHC-OCD-006
nct id: NCT04426773
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study is designed to find Electroencephalogram (EEG) biomarkers to predict transcranial
      direct current stimulation (tDCS) response in obsessive-compulsive disorder.
The purpose of this study is to explore resting state electroencephalography and transcranial
      magnetic stimulation and electroencephalography (TMS-EEG) biomarkers that would predict
      transcranial direct current stimulation (tDCS) response in obsessive-compulsive disorder with
      cathode electrode targeting orbitofrontal cortex (OFC). 30 OCD patients will be recruited to
      this study and performed once a day, five times a week direct current stimulation treatment
      for two weeks. The investigators will assess symptom severity before and after two weeks of
      tDCS. Through the study, Yale-Brown Obsessive Compulsive Scale（Y-BOCS）, the Obsessive
      Compulsive Inventory-Revised (OCI-R), the Beck Depression Inventory(BDI), Pittsburgh sleep
      quality index (PSQI)and side-effect questionnaire will be obtained by a trained investigator.
      Resting state electroencephalography and TMS-EEG testing will be conducted before and after
      tDCS treatment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in symptom improvement assessed by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
time frame: Up to 3 months
description: It assesses the severity of OCD symptoms. The Y-BOCS scale ranges from 0 to 40, with 0 being no symptoms and 40 being severe.The responder on Y-BOCS is defined as a Y-BOCS decrease at least 35% from the baseline at post-treatment.
measure: Change in long-interval intracortical inhibition (LICI) and short interval intracortical inhibition (SICI) measured by TMS-EEG
time frame: Up to 2 weeks
description: LICI and SICI are TMS-EEG paradigm to assess the extent of cortical inhibition. LICI and SICI will be measured using single and paired TMS pulses applied to the OFC. LICI and SICI will be compared between before and after treatment.
measure: EEG biomarkers as predictors of response to tDCS
time frame: baseline
description: LICI and SICI measured by TMS-EEG and resting state EEG will be performed to investigate predictors of response to tDCS in OCD patients.
measure: Change in Obsessive Compulsive Inventory-Revised(OCI-R)
time frame: Up to 3 months
description: It is an inventory of OCD symptoms with 18 items that are rated on a 5-point Likert scale. Total scores range from 0 to 72, with higher scores indicating more severe OCD symptoms.
measure: Change in The Beck Depression Inventory(BDI)
time frame: Up to 3 months
description: It consists of 21 items and uses a 0 to 3 severity scale. Total scores range from 0 to 63, with higher scores indicating more severe depression symptoms.
measure: Change in The Beck Anxiety Inventory (BAI)
time frame: Up to 3 months
description: It is an inventory of anxiety symptoms with 18 items that are rated on a 5-point Likert scale(0 to 4). Total scores range from 0 to 72, with higher scores indicating more severe anxiety symptoms.
measure: Change in Pittsburgh sleep quality index(PSQI)
time frame: Up to 3 months
description: The Pittsburgh Sleep Quality Index (PSQI) contains 19 self-rated questions which measures seven aspects of sleep: (1) subjective sleep quality, (2) sleep latency, (3) sleep duration, (4) habitual sleep efficiency, (5) sleep disturbances, (6) use of sleeping medication, and (7) daytime dysfunction. The 19 self-rated items are combined to form seven component scores, each of which has a range of 0-3 points (0 indicates no difficulty, while 3 indicates severe difficulty). The seven component scores are then summed to yield one global score, with a range of 0-21 points (0 indicating no difficulty, and 21 indicating severe difficulties in all the seven areas of sleep quality).
measure: Change in Side-effect questionnaire
time frame: Up to 3 months
description: It consists of 10-item and uses 0 to 3 severity scale to rate the intensity of side effects. Total scores range from 0 to 30, with higher scores indicating more severe side-effect. It also assesses the relation between side-effect and the effects of tDCS using 0 to 4 scale. Total scores range from 0 to 40, with higher score indicating the greater relation.
arm group label: tDCS treatment
arm group type: Experimental
description: Cathode transcranial direct current stimulation over the right OFC will be applied once a day, 5 days a week, for 2 weeks.
intervention type: Device
intervention name: High-Definition transcranial direct current stimulation
description: The tDCS device will deliver a direct current of 1.5mA for 20 minutes. Cathode electrode will be localized in front of the OFC on the Fp2 point according to the EEG international reference. Four anode electrodes will be placed around FP2 (i.e. Fpz, AFz, AF4, AF8).
arm group label: tDCS treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Zhen Wang, PhD,MD
role: Principal Investigator
affiliation: Shanghai Mental Health Center
last name: Zhen Wang
phone: +86 34773516
email: wangzhen@smhc.org.cn
last name: Zhen Wang
phone: +86 64387250
email: wangzhen@smhc.org.cn
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shanghai Mental Health Center
investigator full name: Zhen Wang
investigator title: vice-president
mesh term: Compulsive Personality Disorder
mesh term: Obsessive-Compulsive Disorder