<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/NCT04432246</url>
  </required_header>
  <id_info>
    <org_study_id>SMHC-OCD-007</org_study_id>
    <nct_id>NCT04432246</nct_id>
  </id_info>
  <brief_title>Electroencephalography Predictors of Repetitive Transcranial Magnetic Stimulation in Obsessive-Compulsive Disorder</brief_title>
  <official_title>Electroencephalography (EEG) Predictors of Repetitive Transcranial Magnetic Stimulation (rTMS) in Obsessive-Compulsive Disorder (OCD): A Preliminary Study</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 used electroencephalogram (EEG) to predict the efficacy of repetitive transcranial&#xD;
      magnetic stimulation (rTMS) in patients with obsessive-compulsive disorder.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Repetitive Transcranial Magnetic Stimulation (rTMS), as a relatively mature non-invasive&#xD;
      neuromodulation technology, has been recommended for the treatment of patients with&#xD;
      refractory OCD in multinational guidelines. However, due to the treatment setting and the&#xD;
      patient's feature, nearly half of the patients have no significant changes after rTMS&#xD;
      treatment.&#xD;
&#xD;
      In order to better predict the outcome of rTMS and improve the treatment efficiency, this&#xD;
      project intends to look for markers that have a predictive effect at baseline or early&#xD;
      treatment. Electroencephalogram (EEG) is a cheap and fast method that usually occurs before&#xD;
      the symptoms change, thus it is possible to determine whether the patient has responded to&#xD;
      the intervention.&#xD;
&#xD;
      In this project, the supplementary motor area (SMA) is selected as the stimulation target.&#xD;
      The individual head magnetic resonance image positioning and navigation and rTMS compatible&#xD;
      real-time EEG acquisition technology are used to monitor the resting state of EEG and rTMS&#xD;
      single pulse stimulation and changes in neural networks before and after treatment. This is a&#xD;
      preliminary exploration looking for effective predictive indicators of efficacy in EEG and&#xD;
      the relationship between EEG and symptoms changes. In order to lay the foundation for further&#xD;
      research and guide clinical treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 11, 2020</start_date>
  <completion_date type="Actual">August 30, 2022</completion_date>
  <primary_completion_date type="Actual">July 28, 2022</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 6 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>EEG biomarkers as predictors of response to rTMS</measure>
    <time_frame>baseline</time_frame>
    <description>TMS-EEG and resting state EEG will be performed to investigate predictors of response to rTMS in OCD patients. The α, β and δ band power in resting state in each brain area of OCD patients will be recorded and analyzed. Also, in TMS treatment, event related potentials (ERPs) including motor evoked potentials (MEPs) amplitude, I waves, α band power and β band power will be analyzed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in The Beck Depression Inventory (BDI)</measure>
    <time_frame>Up to 6 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 6 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 The Perceived Stress Scale(PSS)</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>The Perceived Stress Scale (PSS) has 10 items to assess stress status within four weeks. Items are classified into five levels, from 0 (never) to 4 (very often). Total scores range from 0 to 40. The higher the total score, the stronger the level of stress the patient feels.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Pittsburgh sleep quality index(PSQI)</measure>
    <time_frame>Up to 6 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 Obsessive Compulsive Inventory-Revised(OCI-R)</measure>
    <time_frame>Up to 6 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 Side-effect questionnaire</measure>
    <time_frame>Up to 6 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 rTMS 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="Actual">30</enrollment>
  <condition>Obsessive Compulsive Disorder (OCD)</condition>
  <arm_group>
    <arm_group_label>bilateral SMA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Continuous theta burst stimulation (cTBS) stimulation will be applied over the bilateral SMA once a day, 5 days/week, for 4 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Continuous theta burst stimulation (cTBS)</intervention_name>
    <description>50Hz of 90% MT for 3 pulses train over will be repeated at 200ms for the 40s, 600 pulses</description>
    <arm_group_label>bilateral SMA</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age&gt;18 years old;&#xD;
&#xD;
          -  DSM-5 criteria for OCD;&#xD;
&#xD;
          -  Y-BOCS total score &gt; or = 16 -&gt;or＝9 yrs education&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any additional current psychiatric comorbidity, except for obsessive-compulsive&#xD;
             personality disorder serious suicide risk;&#xD;
&#xD;
          -  the inability to receive rTMS because of metallic implants, or history of seizures，or&#xD;
             history of head injury, or history of neurosurgery;&#xD;
&#xD;
          -  any major medical disease;&#xD;
&#xD;
          -  pregnancy or nursing of an infant;&#xD;
&#xD;
          -  participation in current clinical study;&#xD;
&#xD;
          -  current use of any investigational drug;&#xD;
&#xD;
          -  TMS/DBS treatment at any point in their lifetime;&#xD;
&#xD;
          -  history of long-time use of benzodiazepines&#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>
  <location>
    <facility>
      <name>Shanghai Mental Health Center</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 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>Director</investigator_title>
  </responsible_party>
  <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/NCT04432246
org study id: SMHC-OCD-007
nct id: NCT04432246
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study used electroencephalogram (EEG) to predict the efficacy of repetitive transcranial
      magnetic stimulation (rTMS) in patients with obsessive-compulsive disorder.
Repetitive Transcranial Magnetic Stimulation (rTMS), as a relatively mature non-invasive
      neuromodulation technology, has been recommended for the treatment of patients with
      refractory OCD in multinational guidelines. However, due to the treatment setting and the
      patient's feature, nearly half of the patients have no significant changes after rTMS
      treatment.

      In order to better predict the outcome of rTMS and improve the treatment efficiency, this
      project intends to look for markers that have a predictive effect at baseline or early
      treatment. Electroencephalogram (EEG) is a cheap and fast method that usually occurs before
      the symptoms change, thus it is possible to determine whether the patient has responded to
      the intervention.

      In this project, the supplementary motor area (SMA) is selected as the stimulation target.
      The individual head magnetic resonance image positioning and navigation and rTMS compatible
      real-time EEG acquisition technology are used to monitor the resting state of EEG and rTMS
      single pulse stimulation and changes in neural networks before and after treatment. This is a
      preliminary exploration looking for effective predictive indicators of efficacy in EEG and
      the relationship between EEG and symptoms changes. In order to lay the foundation for further
      research and guide clinical 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 6 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: EEG biomarkers as predictors of response to rTMS
time frame: baseline
description: TMS-EEG and resting state EEG will be performed to investigate predictors of response to rTMS in OCD patients. The α, β and δ band power in resting state in each brain area of OCD patients will be recorded and analyzed. Also, in TMS treatment, event related potentials (ERPs) including motor evoked potentials (MEPs) amplitude, I waves, α band power and β band power will be analyzed.
measure: Change in The Beck Depression Inventory (BDI)
time frame: Up to 6 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 6 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 The Perceived Stress Scale(PSS)
time frame: Up to 6 months
description: The Perceived Stress Scale (PSS) has 10 items to assess stress status within four weeks. Items are classified into five levels, from 0 (never) to 4 (very often). Total scores range from 0 to 40. The higher the total score, the stronger the level of stress the patient feels.
measure: Change in Pittsburgh sleep quality index(PSQI)
time frame: Up to 6 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 Obsessive Compulsive Inventory-Revised(OCI-R)
time frame: Up to 6 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 Side-effect questionnaire
time frame: Up to 6 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 rTMS using 0 to 4 scale. Total scores range from 0 to 40, with higher score indicating the greater relation.
arm group label: bilateral SMA
arm group type: Experimental
description: Continuous theta burst stimulation (cTBS) stimulation will be applied over the bilateral SMA once a day, 5 days/week, for 4 weeks.
intervention type: Device
intervention name: Continuous theta burst stimulation (cTBS)
description: 50Hz of 90% MT for 3 pulses train over will be repeated at 200ms for the 40s, 600 pulses
arm group label: bilateral SMA
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
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shanghai Mental Health Center
investigator full name: Zhen Wang
investigator title: Director
mesh term: Compulsive Personality Disorder
mesh term: Obsessive-Compulsive Disorder