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/NCT05994053</url>
    </required_header>
    <id_info>
      <org_study_id>4555</org_study_id>
      <nct_id>NCT05994053</nct_id>
    </id_info>
    <brief_title>Neuromodulation for a Novel OCD Biomarker and Treatment</brief_title>
    <official_title>Neuromodulation for a Novel OCD Biomarker and Treatment</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Boston University Charles River Campus</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Boston University Charles River Campus</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Although multiple treatments for OCD exist, slow symptom decrease, high remission, and&#xD;
        significant side effects for some OCD patients limit their efficacy. More research into the&#xD;
        precise neural mechanisms and linked cognitive functions in OCD is also necessary. To address&#xD;
        both concerns, this study by Dr. Reinhart and his team will test a new, non-invasive, and&#xD;
        well-tolerated neuromodulation method for reducing OCD symptoms, based on reward-related&#xD;
        rhythms of the orbitofrontal cortex (OFC; a brain region responsible for reward, decision&#xD;
        making and other crucial functions that is affected by OCD). This proposal is based on highly&#xD;
        encouraging preliminary data in both subsyndromal and treatment-resistant populations that&#xD;
        shows rapid reductions in OCD behaviors that last at least 1-3 months. Using high-definition&#xD;
        transcranial alternating current stimulation (HD-tACS) guided by EEG brain wave recordings,&#xD;
        the study will test whether repetitive modulation of relevant rhythm activity in the OFC can&#xD;
        lead to rapid (within five days) and sustainable (up to three months) OCD symptom reduction.&#xD;
        This research aims to increase knowledge of OCD and development of effective treatment with&#xD;
        minimal side effects.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">August 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">August 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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>YBOCS</measure>
      <time_frame>day 5 of intervention</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>YBOCS</measure>
      <time_frame>1 month after intervention</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>YBOCS</measure>
      <time_frame>2 months after intervention</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>YBOCS</measure>
      <time_frame>3 months after intervention</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>EEG beta-gamma rhythms</measure>
      <time_frame>day 5 of intervention</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>EEG beta-gamma rhythms</measure>
      <time_frame>1 month after intervention</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>EEG beta-gamma rhythms</measure>
      <time_frame>2 months after intervention</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>EEG beta-gamma rhythms</measure>
      <time_frame>3 months after intervention</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">90</enrollment>
    <condition>OCD</condition>
    <arm_group>
      <arm_group_label>Active HD-tACS</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>HD-tACS of OFC</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sham HD-tACS</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>HD-tACS of OFC</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>high definition transcranial alternating current stimulation</intervention_name>
      <description>low intensity alternating current to OFC</description>
      <arm_group_label>Active HD-tACS</arm_group_label>
      <arm_group_label>Sham HD-tACS</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          (1) a primary DSM-5 diagnosis of OCD, (2) a score of 16 or greater on the YBOCS (3) at&#xD;
          least 18 years of age; and (4) willingness and ability to provide informed consent and&#xD;
          comply with the requirements of the study protocol.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          (1) a lifetime history of bipolar or psychotic disorders; (2) history of Tourette syndrome;&#xD;
          (3) psychosurgery; (4) substance abuse or dependence (other than nicotine) in the past 3&#xD;
          months; (5) organic brain syndrome, mental retardation or other potentially interfering&#xD;
          cognitive dysfunction; (6) severe depression (MADRS score of 30 or greater); (7) suicidal&#xD;
          risk as determined by moderate or greater score on the Columbia Suicide Severity Rating&#xD;
          Scale (C-SSRS); (8) pregnancy or lactation; (9) changes to pharmacotherapy for OCD or the&#xD;
          initiation of cognitive-behavior therapy within the last 3 months; and (10) specific to the&#xD;
          tACS and EEG procedures no metal implants in head, any implanted electronic devices, any&#xD;
          skin sensitivity, color blindness or impaired vision despite correction, claustrophobia,&#xD;
          and any history of epilepsy or neurological disorder.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Robert Reinhart, PhD</last_name>
      <phone>6173539481</phone>
      <email>rmgr@bu.edu</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Boston University Charles River Campus</investigator_affiliation>
      <investigator_full_name>Robert Reinhart</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <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/NCT05994053
  org study id: 4555
  nct id: NCT05994053
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  Although multiple treatments for OCD exist, slow symptom decrease, high remission, and
        significant side effects for some OCD patients limit their efficacy. More research into the
        precise neural mechanisms and linked cognitive functions in OCD is also necessary. To address
        both concerns, this study by Dr. Reinhart and his team will test a new, non-invasive, and
        well-tolerated neuromodulation method for reducing OCD symptoms, based on reward-related
        rhythms of the orbitofrontal cortex (OFC; a brain region responsible for reward, decision
        making and other crucial functions that is affected by OCD). This proposal is based on highly
        encouraging preliminary data in both subsyndromal and treatment-resistant populations that
        shows rapid reductions in OCD behaviors that last at least 1-3 months. Using high-definition
        transcranial alternating current stimulation (HD-tACS) guided by EEG brain wave recordings,
        the study will test whether repetitive modulation of relevant rhythm activity in the OFC can
        lead to rapid (within five days) and sustainable (up to three months) OCD symptom reduction.
        This research aims to increase knowledge of OCD and development of effective treatment with
        minimal side effects.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: YBOCS
  time frame: day 5 of intervention
  measure: YBOCS
  time frame: 1 month after intervention
  measure: YBOCS
  time frame: 2 months after intervention
  measure: YBOCS
  time frame: 3 months after intervention
  measure: EEG beta-gamma rhythms
  time frame: day 5 of intervention
  measure: EEG beta-gamma rhythms
  time frame: 1 month after intervention
  measure: EEG beta-gamma rhythms
  time frame: 2 months after intervention
  measure: EEG beta-gamma rhythms
  time frame: 3 months after intervention
  arm group label: Active HD-tACS
  arm group type: Active Comparator
  description: HD-tACS of OFC
  arm group label: Sham HD-tACS
  arm group type: Sham Comparator
  description: HD-tACS of OFC
  intervention type: Device
  intervention name: high definition transcranial alternating current stimulation
  description: low intensity alternating current to OFC
  arm group label: Active HD-tACS
  arm group label: Sham HD-tACS
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Robert Reinhart, PhD
  phone: 6173539481
  email: rmgr@bu.edu
  responsible party type: Principal Investigator
  investigator affiliation: Boston University Charles River Campus
  investigator full name: Robert Reinhart
  investigator title: Associate Professor
  sharing ipd: No