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/NCT05995951</url>
    </required_header>
    <id_info>
      <org_study_id>1005-20-RMC</org_study_id>
      <nct_id>NCT05995951</nct_id>
    </id_info>
    <brief_title>Deep Brain Stimulation Surgery for the Treatment of Refractory Obsessive-Compulsive Disorder</brief_title>
    <official_title>Deep Brain Stimulation Surgery for the Treatment of Refractory Obsessive-Compulsive Disorder</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Rabin Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Rabin Medical Center</source>
    <oversight_info>
      <has_dmc>No</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>
        This study will include two parts. The first part will include two patients in a non-blinded,&#xD;
        non-randomized, open trial. They will undergo Deep Bran Stimulation (DBS) for OCD (targeting&#xD;
        the amSTN), as clinically accepted and approved in Israel (by the MOH) and in other countries&#xD;
        in Europe and the US. The second part will include eight patients. This part will be an&#xD;
        interventional, randomized, double-blinded clinical trial (patient and psychiatrist; the&#xD;
        neurosurgeon will activate stimulation during the randomization period and will not be&#xD;
        blinded). All subjects will undergo standard pre-operative psychiatric and neurosurgical&#xD;
        assessment. Around 4-6 weeks later subjects will undergo implantation of Medtronic&#xD;
        implantable DBS system (bilateral brain leads model 3389, lead extenders and PERCEPT pulse&#xD;
        generator). Intraoperative recordings will include single unit and local field potentials&#xD;
        (LFP) for target identification and validation, as accepted for clinical use. In the second&#xD;
        part of the study, blinded randomization for treatment or sham-control arms (1:1 ratio) will&#xD;
        be held two weeks post-operation. Treatment and sham-control arms will continue for four&#xD;
        months. At the end of four months treatment, the groups will be crossed-over for another four&#xD;
        months. Thus, the sham-control group will start treatment (using pre-defined stimulation&#xD;
        parameters) and the treatment group will start sham stimulation. Four months later (six and a&#xD;
        half months from surgery), randomization will be over, and both arms will get open-label&#xD;
        active treatment. Psychiatric assessments post-operation will take place after two weeks, one&#xD;
        month, and then once every six weeks, in the first year for all study patients. Chronic&#xD;
        recordings will take place using the clinically used and approved PERCEPT DBS pulse generator&#xD;
        during the first year after surgery.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Obsessive-compulsive disorder (OCD) is characterized by the presence of intrusive obsessions,&#xD;
        compulsions, or both. Despite undergoing optimal pharmacological and psychological treatment,&#xD;
        around a tenth of patients remain with refractory OCD, with a great impact on their everyday&#xD;
        function and quality of life.&#xD;
  &#xD;
        Deep brain stimulation (DBS) surgery is a safe and effective treatment, used for movement&#xD;
        disorders for over 20 years now, and lately was approved worldwide also for intractable&#xD;
        epilepsy. In the past decade, many studies of DBS for refractory OCD proved safety and&#xD;
        effectiveness with 50% reduction in OCD symptoms of the most refractory patients.&#xD;
  &#xD;
        This study will include two parts. The first part will include two patients in a non-blinded,&#xD;
        non-randomized, open trial. They will undergo Deep Bran Stimulation (DBS) for OCD (targeting&#xD;
        the amSTN), as clinically accepted and approved in Israel (by the MOH) and in other countries&#xD;
        in Europe and the US. The second part will include eight patients. This part will be an&#xD;
        interventional, randomized, double-blinded clinical trial (patient and psychiatrist; the&#xD;
        neurosurgeon will activate stimulation during the randomization period and will not be&#xD;
        blinded). All subjects will undergo standard pre-operative psychiatric and neurosurgical&#xD;
        assessment. Around 4-6 weeks later subjects will undergo implantation of Medtronic&#xD;
        implantable DBS system (bilateral brain leads model 3389, lead extenders and PERCEPT pulse&#xD;
        generator). Intraoperative recordings will include single unit and local field potentials&#xD;
        (LFP) for target identification and validation, as accepted for clinical use. In the second&#xD;
        part of the study, blinded randomization for treatment or sham-control arms (1:1 ratio) will&#xD;
        be held two weeks post-operation. Treatment and sham-control arms will continue for four&#xD;
        months. At the end of four months treatment, the groups will be crossed-over for another four&#xD;
        months. Thus, the sham-control group will start treatment (using pre-defined stimulation&#xD;
        parameters) and the treatment group will start sham stimulation. four months later (six and a&#xD;
        half months from surgery), randomization will be over, and both arms will get open-label&#xD;
        active treatment. Psychiatric assessments post-operation will take place after two weeks, one&#xD;
        month, and then once every six weeks, in the first year for all study patients. Chronic&#xD;
        recordings will take place using the clinically used and approved PERCEPT DBS pulse generator&#xD;
        during the first year after surgery.&#xD;
  &#xD;
        Primary aims:&#xD;
  &#xD;
          1. Assess the effects of the anteromedial sub-thalamic nucleus (amSTN)/medial forebrain&#xD;
             bundle (MFB) stimulation on obsessive/compulsive symptoms&#xD;
  &#xD;
          2. Map the amSTN using neuronal responses (single unit and LFP recordings) to&#xD;
             cognitive-emotion provocation task during surgery&#xD;
  &#xD;
          3. Record chronic brain activity with the implanted pulse generator and look for neuronal&#xD;
             signatures correlated with symptom severity.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">October 12, 2021</start_date>
    <completion_date type="Anticipated">September 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 1, 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>Crossover Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Assessment of the efficacy of amSTN/MFB stimulation on OCD symptoms - YBOCS score (0-40)</measure>
      <time_frame>baseline (before stimulation initiation)</time_frame>
      <description>Assessment of the efficacy of amSTN/MFB stimulation on OCD symptoms. This will be assessed by the YBOCS. More than a 35% reduction on the YBOCS will be considered clinically significant. YBOCS score (0-40) - lower scores mean a better outcome.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Assessment of the efficacy of amSTN/MFB stimulation on OCD symptoms - YBOCS score (0-40)</measure>
      <time_frame>four months post-implantation</time_frame>
      <description>Assessment of the efficacy of amSTN/MFB stimulation on OCD symptoms. This will be assessed by the YBOCS. More than a 35% reduction on the YBOCS will be considered clinically significant. YBOCS score (0-40) - lower scores mean a better outcome.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Assessment of the efficacy of amSTN/MFB stimulation on OCD symptoms - YBOCS score (0-40)</measure>
      <time_frame>eight months post-implantation</time_frame>
      <description>Assessment of the efficacy of amSTN/MFB stimulation on OCD symptoms. This will be assessed by the YBOCS. More than a 35% reduction on the YBOCS will be considered clinically significant. YBOCS score (0-40) - lower scores mean a better outcome.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Assessment of the efficacy of amSTN/MFB stimulation on OCD symptoms - YBOCS score (0-40)</measure>
      <time_frame>12 months post-implantation</time_frame>
      <description>Assessment of the efficacy of amSTN/MFB stimulation on OCD symptoms. This will be assessed by the YBOCS. More than a 35% reduction on the YBOCS will be considered clinically significant. YBOCS score (0-40) - lower scores mean a better outcome.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Assessment of the association between amSTN electrophysiological discharge and cognitive/ emotional measures</measure>
      <time_frame>baseline (before stimulation initiation)</time_frame>
      <description>Assessment of the association between amSTN electrophysiological discharge and cognitive/ emotional measures. This will be measured by correlating various measures of discharge (rate, amplitude, coherence, phase, burstiness, and cross-frequency coupling) and task-related activity (magnitude of modulation, directionality, and amplitude sensitivity) with the severity of cognitive and mood impairments of patients undergoing surgery.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Assessment of the association between amSTN electrophysiological discharge and cognitive/ emotional measures</measure>
      <time_frame>four months post-implantation</time_frame>
      <description>Assessment of the association between amSTN electrophysiological discharge and cognitive/ emotional measures. This will be measured by correlating various measures of discharge (rate, amplitude, coherence, phase, burstiness, and cross-frequency coupling) and task-related activity (magnitude of modulation, directionality, and amplitude sensitivity) with the severity of cognitive and mood impairments of patients undergoing surgery.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Assessment of the association between amSTN electrophysiological discharge and cognitive/ emotional measures</measure>
      <time_frame>eight months post-implantation</time_frame>
      <description>Assessment of the association between amSTN electrophysiological discharge and cognitive/ emotional measures. This will be measured by correlating various measures of discharge (rate, amplitude, coherence, phase, burstiness, and cross-frequency coupling) and task-related activity (magnitude of modulation, directionality, and amplitude sensitivity) with the severity of cognitive and mood impairments of patients undergoing surgery.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Assessment of the association between amSTN electrophysiological discharge and cognitive/ emotional measures</measure>
      <time_frame>12 months post-implantation</time_frame>
      <description>Assessment of the association between amSTN electrophysiological discharge and cognitive/ emotional measures. This will be measured by correlating various measures of discharge (rate, amplitude, coherence, phase, burstiness, and cross-frequency coupling) and task-related activity (magnitude of modulation, directionality, and amplitude sensitivity) with the severity of cognitive and mood impairments of patients undergoing surgery.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The effects of DBS on mood</measure>
      <time_frame>baseline (before stimulation initiation)</time_frame>
      <description>The effects of DBS on mood and quality of life will be tested using various scales: Hamilton Scale for Anxiety (HAM-A), Hamilton Scale for Depression (HAM-D21), Brief Psychiatric Rating Scale (BPRS), overall state (Clinical Global Inventory [CGI]), and Mini-Mental State Examination (MMSE).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The effects of DBS on mood</measure>
      <time_frame>four months post-implantation</time_frame>
      <description>The effects of DBS on mood and quality of life will be tested using various scales: Hamilton Scale for Anxiety (HAM-A), Hamilton Scale for Depression (HAM-D21), Brief Psychiatric Rating Scale (BPRS), overall state (Clinical Global Inventory [CGI]), and Mini-Mental State Examination (MMSE).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The effects of DBS on mood</measure>
      <time_frame>eight months post-implantation</time_frame>
      <description>The effects of DBS on mood and quality of life will be tested using various scales: Hamilton Scale for Anxiety (HAM-A), Hamilton Scale for Depression (HAM-D21), Brief Psychiatric Rating Scale (BPRS), overall state (Clinical Global Inventory [CGI]), and Mini-Mental State Examination (MMSE).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The effects of DBS on mood</measure>
      <time_frame>12 months post-implantation</time_frame>
      <description>The effects of DBS on mood and quality of life will be tested using various scales: Hamilton Scale for Anxiety (HAM-A), Hamilton Scale for Depression (HAM-D21), Brief Psychiatric Rating Scale (BPRS), overall state (Clinical Global Inventory [CGI]), and Mini-Mental State Examination (MMSE).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The effects of DBS on quality of life</measure>
      <time_frame>baseline (before stimulation initiation)</time_frame>
      <description>The effects of DBS on mood and quality of life will be tested using various scales: Hamilton Scale for Anxiety (HAM-A), Hamilton Scale for Depression (HAM-D21), Brief Psychiatric Rating Scale (BPRS), overall state (Clinical Global Inventory [CGI]), and Mini-Mental State Examination (MMSE).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The effects of DBS on quality of life</measure>
      <time_frame>four months post-implantation</time_frame>
      <description>The effects of DBS on mood and quality of life will be tested using various scales: Hamilton Scale for Anxiety (HAM-A), Hamilton Scale for Depression (HAM-D21), Brief Psychiatric Rating Scale (BPRS), overall state (Clinical Global Inventory [CGI]), and Mini-Mental State Examination (MMSE).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The effects of DBS on quality of life</measure>
      <time_frame>eight months post-implantation</time_frame>
      <description>The effects of DBS on mood and quality of life will be tested using various scales: Hamilton Scale for Anxiety (HAM-A), Hamilton Scale for Depression (HAM-D21), Brief Psychiatric Rating Scale (BPRS), overall state (Clinical Global Inventory [CGI]), and Mini-Mental State Examination (MMSE).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The effects of DBS on quality of life</measure>
      <time_frame>12 months post-implantation</time_frame>
      <description>The effects of DBS on mood and quality of life will be tested using various scales: Hamilton Scale for Anxiety (HAM-A), Hamilton Scale for Depression (HAM-D21), Brief Psychiatric Rating Scale (BPRS), overall state (Clinical Global Inventory [CGI]), and Mini-Mental State Examination (MMSE).</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Obsessive-Compulsive Disorder</condition>
    <arm_group>
      <arm_group_label>Deep Bran Stimulation (DBS) - Treatment group</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Treatment group will undergo Deep Bran Stimulation (DBS) for OCD (targeting the amSTN) for four months.&#xD;
  At the end of four months treatment, the groups will be crossed-over for another four months. Thus, the sham group will start active stimulation and the treatment group will start sham treatment for four months.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sham-control</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>sham stimulation for four months.&#xD;
  At the end of four months treatment, the groups will be crossed-over for another fourmonths. Thus, the sham group will start active stimulation and the treatment group will start sham treatment for four months.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Deep Bran Stimulation (DBS)</intervention_name>
      <description>Deep brain stimulation (DBS) surgery targeting the antero-medial Sub-Thalamic Nucleus (amSTN)</description>
      <arm_group_label>Deep Bran Stimulation (DBS) - Treatment group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Sham-stimulation</intervention_name>
      <description>Deep brain stimulation (DBS) surgery - Sham stimulation</description>
      <arm_group_label>Sham-control</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with a diagnosis of obsessive-compulsive disorder according to DSM 5&#xD;
               criteria, diagnosed by three independent psychiatrists not routinely involved with the&#xD;
               patients' treatment.&#xD;
  &#xD;
            -  Severe OCD assessed by the Yale-Brown Obsessive-Compulsive Scale (YBOCS) with a score&#xD;
               of more than 25.&#xD;
  &#xD;
            -  Refractory OCD; severe symptoms and impairment for more than 5 years despite&#xD;
               pharmacological and psychological treatment.&#xD;
  &#xD;
            -  Have failed to improve following treatment with at least two serotonin transport&#xD;
               inhibitors and one augmenting agent taken for an adequate time period.&#xD;
  &#xD;
            -  Having failed to improve despite adequate psychotherapy.&#xD;
  &#xD;
            -  Meet established criteria for implantation of a deep brain stimulation system.&#xD;
  &#xD;
            -  Patients between ages 18 and 75.&#xD;
  &#xD;
            -  Ability to understand and sign written informed consent by the patient.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Diagnosis of severe major depression disorder (MDD) with psychotic features.&#xD;
  &#xD;
            -  Significant suicidal risk [Hamilton Depression scale item 3 (suicide) &gt;2].&#xD;
  &#xD;
            -  Comorbidity with any primary Psychotic Disorder, Bipolar Disorder, Post-Traumatic&#xD;
               Stress Disorder (PTSD), Eating Disorder, Autistics Spectrum Disorder.&#xD;
  &#xD;
            -  History of substance or alcohol dependence or abuse in the preceding 12 months.&#xD;
  &#xD;
            -  Significant cognitive decline, measured by Mini-Mental State Examination (MMSE &lt;26)&#xD;
               and Montreal Cognitive Assessment (MoCA; &lt;24).&#xD;
  &#xD;
            -  Any other current clinically significant neurological disorder or medical illness&#xD;
               affecting brain function, other than a tic disorder.&#xD;
  &#xD;
            -  Any clinically significant abnormality on preoperative MRI.&#xD;
  &#xD;
            -  Any DBS contraindication, infection, coagulopathy, significant cardiac risk factors,&#xD;
               or other significant medical risk factors for surgery.&#xD;
  &#xD;
            -  Pregnancy.&#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_official>
      <last_name>Idit Idit</last_name>
      <role>Principal Investigator</role>
      <affiliation>Rabin Medical Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Idit TamirIdit</last_name>
      <phone>+972 3 9376406</phone>
      <email>iditta1@clalit.org.il</email>
    </overall_contact>
    <location>
      <facility>
        <name>Rabin Medical Center</name>
        <address>
          <city>Petah tikva</city>
          <country>Israel</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Idit Tamir, MD</last_name>
      </contact>
      <contact_backup>
        <last_name>Belaynesh Keren Melke, BSc</last_name>
        <phone>+972 547576642</phone>
      </contact_backup>
      <investigator>
        <last_name>Idit Tamir, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Israel</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>April 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 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>Rabin Medical Center</investigator_affiliation>
      <investigator_full_name>Idit tamit</investigator_full_name>
      <investigator_title>Principal Investigator</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>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT05995951
  org study id: 1005-20-RMC
  nct id: NCT05995951
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study will include two parts. The first part will include two patients in a non-blinded,
        non-randomized, open trial. They will undergo Deep Bran Stimulation (DBS) for OCD (targeting
        the amSTN), as clinically accepted and approved in Israel (by the MOH) and in other countries
        in Europe and the US. The second part will include eight patients. This part will be an
        interventional, randomized, double-blinded clinical trial (patient and psychiatrist; the
        neurosurgeon will activate stimulation during the randomization period and will not be
        blinded). All subjects will undergo standard pre-operative psychiatric and neurosurgical
        assessment. Around 4-6 weeks later subjects will undergo implantation of Medtronic
        implantable DBS system (bilateral brain leads model 3389, lead extenders and PERCEPT pulse
        generator). Intraoperative recordings will include single unit and local field potentials
        (LFP) for target identification and validation, as accepted for clinical use. In the second
        part of the study, blinded randomization for treatment or sham-control arms (1:1 ratio) will
        be held two weeks post-operation. Treatment and sham-control arms will continue for four
        months. At the end of four months treatment, the groups will be crossed-over for another four
        months. Thus, the sham-control group will start treatment (using pre-defined stimulation
        parameters) and the treatment group will start sham stimulation. Four months later (six and a
        half months from surgery), randomization will be over, and both arms will get open-label
        active treatment. Psychiatric assessments post-operation will take place after two weeks, one
        month, and then once every six weeks, in the first year for all study patients. Chronic
        recordings will take place using the clinically used and approved PERCEPT DBS pulse generator
        during the first year after surgery.
  Obsessive-compulsive disorder (OCD) is characterized by the presence of intrusive obsessions,
        compulsions, or both. Despite undergoing optimal pharmacological and psychological treatment,
        around a tenth of patients remain with refractory OCD, with a great impact on their everyday
        function and quality of life.
  
        Deep brain stimulation (DBS) surgery is a safe and effective treatment, used for movement
        disorders for over 20 years now, and lately was approved worldwide also for intractable
        epilepsy. In the past decade, many studies of DBS for refractory OCD proved safety and
        effectiveness with 50% reduction in OCD symptoms of the most refractory patients.
  
        This study will include two parts. The first part will include two patients in a non-blinded,
        non-randomized, open trial. They will undergo Deep Bran Stimulation (DBS) for OCD (targeting
        the amSTN), as clinically accepted and approved in Israel (by the MOH) and in other countries
        in Europe and the US. The second part will include eight patients. This part will be an
        interventional, randomized, double-blinded clinical trial (patient and psychiatrist; the
        neurosurgeon will activate stimulation during the randomization period and will not be
        blinded). All subjects will undergo standard pre-operative psychiatric and neurosurgical
        assessment. Around 4-6 weeks later subjects will undergo implantation of Medtronic
        implantable DBS system (bilateral brain leads model 3389, lead extenders and PERCEPT pulse
        generator). Intraoperative recordings will include single unit and local field potentials
        (LFP) for target identification and validation, as accepted for clinical use. In the second
        part of the study, blinded randomization for treatment or sham-control arms (1:1 ratio) will
        be held two weeks post-operation. Treatment and sham-control arms will continue for four
        months. At the end of four months treatment, the groups will be crossed-over for another four
        months. Thus, the sham-control group will start treatment (using pre-defined stimulation
        parameters) and the treatment group will start sham stimulation. four months later (six and a
        half months from surgery), randomization will be over, and both arms will get open-label
        active treatment. Psychiatric assessments post-operation will take place after two weeks, one
        month, and then once every six weeks, in the first year for all study patients. Chronic
        recordings will take place using the clinically used and approved PERCEPT DBS pulse generator
        during the first year after surgery.
  
        Primary aims:
  
          1. Assess the effects of the anteromedial sub-thalamic nucleus (amSTN)/medial forebrain
             bundle (MFB) stimulation on obsessive/compulsive symptoms
  
          2. Map the amSTN using neuronal responses (single unit and LFP recordings) to
             cognitive-emotion provocation task during surgery
  
          3. Record chronic brain activity with the implanted pulse generator and look for neuronal
             signatures correlated with symptom severity.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: Assessment of the efficacy of amSTN/MFB stimulation on OCD symptoms - YBOCS score (0-40)
  time frame: baseline (before stimulation initiation)
  description: Assessment of the efficacy of amSTN/MFB stimulation on OCD symptoms. This will be assessed by the YBOCS. More than a 35% reduction on the YBOCS will be considered clinically significant. YBOCS score (0-40) - lower scores mean a better outcome.
  measure: Assessment of the efficacy of amSTN/MFB stimulation on OCD symptoms - YBOCS score (0-40)
  time frame: four months post-implantation
  description: Assessment of the efficacy of amSTN/MFB stimulation on OCD symptoms. This will be assessed by the YBOCS. More than a 35% reduction on the YBOCS will be considered clinically significant. YBOCS score (0-40) - lower scores mean a better outcome.
  measure: Assessment of the efficacy of amSTN/MFB stimulation on OCD symptoms - YBOCS score (0-40)
  time frame: eight months post-implantation
  description: Assessment of the efficacy of amSTN/MFB stimulation on OCD symptoms. This will be assessed by the YBOCS. More than a 35% reduction on the YBOCS will be considered clinically significant. YBOCS score (0-40) - lower scores mean a better outcome.
  measure: Assessment of the efficacy of amSTN/MFB stimulation on OCD symptoms - YBOCS score (0-40)
  time frame: 12 months post-implantation
  description: Assessment of the efficacy of amSTN/MFB stimulation on OCD symptoms. This will be assessed by the YBOCS. More than a 35% reduction on the YBOCS will be considered clinically significant. YBOCS score (0-40) - lower scores mean a better outcome.
  measure: Assessment of the association between amSTN electrophysiological discharge and cognitive/ emotional measures
  time frame: baseline (before stimulation initiation)
  description: Assessment of the association between amSTN electrophysiological discharge and cognitive/ emotional measures. This will be measured by correlating various measures of discharge (rate, amplitude, coherence, phase, burstiness, and cross-frequency coupling) and task-related activity (magnitude of modulation, directionality, and amplitude sensitivity) with the severity of cognitive and mood impairments of patients undergoing surgery.
  measure: Assessment of the association between amSTN electrophysiological discharge and cognitive/ emotional measures
  time frame: four months post-implantation
  description: Assessment of the association between amSTN electrophysiological discharge and cognitive/ emotional measures. This will be measured by correlating various measures of discharge (rate, amplitude, coherence, phase, burstiness, and cross-frequency coupling) and task-related activity (magnitude of modulation, directionality, and amplitude sensitivity) with the severity of cognitive and mood impairments of patients undergoing surgery.
  measure: Assessment of the association between amSTN electrophysiological discharge and cognitive/ emotional measures
  time frame: eight months post-implantation
  description: Assessment of the association between amSTN electrophysiological discharge and cognitive/ emotional measures. This will be measured by correlating various measures of discharge (rate, amplitude, coherence, phase, burstiness, and cross-frequency coupling) and task-related activity (magnitude of modulation, directionality, and amplitude sensitivity) with the severity of cognitive and mood impairments of patients undergoing surgery.
  measure: Assessment of the association between amSTN electrophysiological discharge and cognitive/ emotional measures
  time frame: 12 months post-implantation
  description: Assessment of the association between amSTN electrophysiological discharge and cognitive/ emotional measures. This will be measured by correlating various measures of discharge (rate, amplitude, coherence, phase, burstiness, and cross-frequency coupling) and task-related activity (magnitude of modulation, directionality, and amplitude sensitivity) with the severity of cognitive and mood impairments of patients undergoing surgery.
  measure: The effects of DBS on mood
  time frame: baseline (before stimulation initiation)
  description: The effects of DBS on mood and quality of life will be tested using various scales: Hamilton Scale for Anxiety (HAM-A), Hamilton Scale for Depression (HAM-D21), Brief Psychiatric Rating Scale (BPRS), overall state (Clinical Global Inventory [CGI]), and Mini-Mental State Examination (MMSE).
  measure: The effects of DBS on mood
  time frame: four months post-implantation
  description: The effects of DBS on mood and quality of life will be tested using various scales: Hamilton Scale for Anxiety (HAM-A), Hamilton Scale for Depression (HAM-D21), Brief Psychiatric Rating Scale (BPRS), overall state (Clinical Global Inventory [CGI]), and Mini-Mental State Examination (MMSE).
  measure: The effects of DBS on mood
  time frame: eight months post-implantation
  description: The effects of DBS on mood and quality of life will be tested using various scales: Hamilton Scale for Anxiety (HAM-A), Hamilton Scale for Depression (HAM-D21), Brief Psychiatric Rating Scale (BPRS), overall state (Clinical Global Inventory [CGI]), and Mini-Mental State Examination (MMSE).
  measure: The effects of DBS on mood
  time frame: 12 months post-implantation
  description: The effects of DBS on mood and quality of life will be tested using various scales: Hamilton Scale for Anxiety (HAM-A), Hamilton Scale for Depression (HAM-D21), Brief Psychiatric Rating Scale (BPRS), overall state (Clinical Global Inventory [CGI]), and Mini-Mental State Examination (MMSE).
  measure: The effects of DBS on quality of life
  time frame: baseline (before stimulation initiation)
  description: The effects of DBS on mood and quality of life will be tested using various scales: Hamilton Scale for Anxiety (HAM-A), Hamilton Scale for Depression (HAM-D21), Brief Psychiatric Rating Scale (BPRS), overall state (Clinical Global Inventory [CGI]), and Mini-Mental State Examination (MMSE).
  measure: The effects of DBS on quality of life
  time frame: four months post-implantation
  description: The effects of DBS on mood and quality of life will be tested using various scales: Hamilton Scale for Anxiety (HAM-A), Hamilton Scale for Depression (HAM-D21), Brief Psychiatric Rating Scale (BPRS), overall state (Clinical Global Inventory [CGI]), and Mini-Mental State Examination (MMSE).
  measure: The effects of DBS on quality of life
  time frame: eight months post-implantation
  description: The effects of DBS on mood and quality of life will be tested using various scales: Hamilton Scale for Anxiety (HAM-A), Hamilton Scale for Depression (HAM-D21), Brief Psychiatric Rating Scale (BPRS), overall state (Clinical Global Inventory [CGI]), and Mini-Mental State Examination (MMSE).
  measure: The effects of DBS on quality of life
  time frame: 12 months post-implantation
  description: The effects of DBS on mood and quality of life will be tested using various scales: Hamilton Scale for Anxiety (HAM-A), Hamilton Scale for Depression (HAM-D21), Brief Psychiatric Rating Scale (BPRS), overall state (Clinical Global Inventory [CGI]), and Mini-Mental State Examination (MMSE).
  arm group label: Deep Bran Stimulation (DBS) - Treatment group
  arm group type: Other
  description: Treatment group will undergo Deep Bran Stimulation (DBS) for OCD (targeting the amSTN) for four months.
  At the end of four months treatment, the groups will be crossed-over for another four months. Thus, the sham group will start active stimulation and the treatment group will start sham treatment for four months.
  arm group label: Sham-control
  arm group type: Other
  description: sham stimulation for four months.
  At the end of four months treatment, the groups will be crossed-over for another fourmonths. Thus, the sham group will start active stimulation and the treatment group will start sham treatment for four months.
  intervention type: Device
  intervention name: Deep Bran Stimulation (DBS)
  description: Deep brain stimulation (DBS) surgery targeting the antero-medial Sub-Thalamic Nucleus (amSTN)
  arm group label: Deep Bran Stimulation (DBS) - Treatment group
  intervention type: Device
  intervention name: Sham-stimulation
  description: Deep brain stimulation (DBS) surgery - Sham stimulation
  arm group label: Sham-control
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Idit Idit
  role: Principal Investigator
  affiliation: Rabin Medical Center
  last name: Idit TamirIdit
  phone: +972 3 9376406
  email: iditta1@clalit.org.il
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: Israel
  responsible party type: Principal Investigator
  investigator affiliation: Rabin Medical Center
  investigator full name: Idit tamit
  investigator title: Principal Investigator
  mesh term: Compulsive Personality Disorder
  mesh term: Obsessive-Compulsive Disorder
  sharing ipd: Undecided