<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/NCT02206945</url>
  </required_header>
  <id_info>
    <org_study_id>0206017435-2</org_study_id>
    <secondary_id>R01MH100068</secondary_id>
    <nct_id>NCT02206945</nct_id>
  </id_info>
  <brief_title>Neurofeedback for Obsessive-Compulsive Disorder (OCD)</brief_title>
  <official_title>Neurofeedback of Activity in the Orbitofrontal Cortex for OCD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Yale University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to train patients with obsessive-compulsive disorder to control a&#xD;
      region of their brain that has been associated with their symptoms. Patients in the&#xD;
      experimental group will be given direct feedback regarding activity in this brain area while&#xD;
      they are undergoing functional magnetic resonance imaging (fMRI) scanning, and will try to&#xD;
      learn to control activity in the region during these feedback sessions. A separate group of&#xD;
      patients will be given a control form of feedback that we do not believe can have clinical&#xD;
      benefits. Our primary hypothesis is that the neurofeedback training will reduce OCD symptoms&#xD;
      more than the control feedback.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Original study design recruiting controls who were matched to the experimental group was&#xD;
      changed to a randomized design prior to enrollment of the first participant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2015</start_date>
  <completion_date type="Actual">November 2021</completion_date>
  <primary_completion_date type="Actual">November 2021</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>A modified version of the Yale-Brown Obsessive-Compulsive Symptom scale (Y-BOCS) will be used, that queries subjects regarding symptoms</measure>
    <time_frame>Immediately before intervention</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>A modified version of the Yale-Brown Obsessive-Compulsive Symptom scale (Y-BOCS) will be used, that queries subjects regarding symptoms</measure>
    <time_frame>Approximately 4 days post-intervention</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Control over target brain area</measure>
    <time_frame>Approximately 4 days pre-intervention</time_frame>
    <description>Control task scans will be conducted in which subjects are cued to at times to increase activity in their target brain area and at other times to decrease activity in their target brain area. During both conditions they will be presented with symptom provoking images. The percent signal change in the BOLD signal in the target area during increase relative to decrease blocks will be used as the measure of control over the brain area.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Control over the target brain area.</measure>
    <time_frame>Approximately 4 days post-intervention</time_frame>
    <description>Control task scans will be conducted in which subjects are cued to at times to increase activity in their target brain area and at other times to decrease activity in their target brain area. During both conditions they will be presented with symptom provoking images. The percent signal change in the BOLD signal in the target area during increase relative to decrease blocks will be used as the measure of control over the brain area.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Functional connectivity patterns in the brain</measure>
    <time_frame>Approximately 4 days pre-intervention</time_frame>
    <description>Functional connectivity will be assessed based on temporal correlations in resting state functional imaging data.</description>
  </other_outcome>
  <other_outcome>
    <measure>Functional connectivity patterns in the brain</measure>
    <time_frame>Approximately 4 days post-intervention</time_frame>
    <description>Functional connectivity will be assessed based on temporal correlations in resting state functional imaging data.</description>
  </other_outcome>
  <other_outcome>
    <measure>A modified version of the Yale-Brown Obsessive-Compulsive Symptom scale (Y-BOCS) will be used, that queries subjects regarding symptoms</measure>
    <time_frame>Approximately 2 weeks post-intervention</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>A modified version of the Yale-Brown Obsessive-Compulsive Symptom scale (Y-BOCS) will be used, that queries subjects regarding symptoms</measure>
    <time_frame>Approximately 4 weeks post-intervention</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Average self-report of washing/checking anxiety to provocative images during a session in which they are instructed to control anxiety</measure>
    <time_frame>Approximately 4 days pre-intervention</time_frame>
    <description>Subject instructed to control anxiety, shown provocative pictures and self-reports the anxiety they experience for each image. Responses averaged over session for a single number representing level of anxiety experienced despite efforts to control that anxiety.</description>
  </other_outcome>
  <other_outcome>
    <measure>Average self-report of washing/checking anxiety to provocative images during a session in which they are instructed to control anxiety.</measure>
    <time_frame>Approximately 4 days post-intervention</time_frame>
    <description>Subject instructed to control anxiety, shown provocative pictures and self-reports the anxiety they experience for each image. Responses averaged over session for a single number representing level of anxiety experienced despite efforts to control that anxiety.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Obsessive-Compulsive Disorder</condition>
  <arm_group>
    <arm_group_label>neurofeedback</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two imaging sessions of neurofeedback.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control feedback</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Two imaging sessions of feedback</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>neurofeedback</intervention_name>
    <description>Subject provided with feedback of activity in target brain area in the form of a line graph. Cued to try to make the line go up at certain times and down at other times.</description>
    <arm_group_label>neurofeedback</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>control feedback</intervention_name>
    <description>Subject provided with a control/placebo type of feedback in the form of a line graph. Cued to try to make the line go up at certain times and down at other times.</description>
    <arm_group_label>control feedback</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Primary Diagnosis of Current OCD, based on Diagnostic and Statistical Manual (DSM-IV)&#xD;
             criteria, a Y-BOCS (Yale-Brown Obsessive-Compulsive Scale) score &gt;=16&#xD;
&#xD;
          -  Principle OCD symptoms- Primary symptoms must be either Cleaning/Contamination or&#xD;
             Checking; other symptoms okay&#xD;
&#xD;
          -  Unmedicated (or medications stable for 8 weeks).&#xD;
&#xD;
          -  Research group must be able to identify a target region in the orbitofrontal cortex&#xD;
             that is related to symptoms&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active Psychosis; Pervasive Developmental Disorder ; epilepsy or other major&#xD;
             neurological disorder&#xD;
&#xD;
          -  History of major head trauma or psychosurgery&#xD;
&#xD;
          -  Active Substance Abuse within 6 months&#xD;
&#xD;
          -  Seizure disorder or other significant neurological disorder&#xD;
&#xD;
          -  Active Suicidality&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  severe claustrophobia, ferromagnetic metal in the body, a pacemaker or defibrillator,&#xD;
             or any other condition that would make MRI scanning unsafe or inappropriate&#xD;
&#xD;
          -  any psychotropic medication other than a selective serotonin reuptake inhibitor (SSRI)&#xD;
             antidepressant, anafranil, or a low-dose hypnotic or anxiolytic taken on an as-needed&#xD;
             basis&#xD;
&#xD;
          -  active cognitive/behavioral therapy initiated within the last 3 months (continuation&#xD;
             of established maintenance therapy that has been going on for longer than 3 months&#xD;
             will not be grounds for exclusion)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michelle Hampson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yale University School of Medicine</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06520</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>July 28, 2014</study_first_submitted>
  <study_first_submitted_qc>July 31, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 1, 2014</study_first_posted>
  <last_update_submitted>February 10, 2022</last_update_submitted>
  <last_update_submitted_qc>February 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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/NCT02206945
org study id: 0206017435-2
secondary id: R01MH100068
nct id: NCT02206945
lead sponsor: 
collaborator: 
has dmc: No
The aim of this study is to train patients with obsessive-compulsive disorder to control a
      region of their brain that has been associated with their symptoms. Patients in the
      experimental group will be given direct feedback regarding activity in this brain area while
      they are undergoing functional magnetic resonance imaging (fMRI) scanning, and will try to
      learn to control activity in the region during these feedback sessions. A separate group of
      patients will be given a control form of feedback that we do not believe can have clinical
      benefits. Our primary hypothesis is that the neurofeedback training will reduce OCD symptoms
      more than the control feedback.
Original study design recruiting controls who were matched to the experimental group was
      changed to a randomized design prior to enrollment of the first participant.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: A modified version of the Yale-Brown Obsessive-Compulsive Symptom scale (Y-BOCS) will be used, that queries subjects regarding symptoms
time frame: Immediately before intervention
measure: A modified version of the Yale-Brown Obsessive-Compulsive Symptom scale (Y-BOCS) will be used, that queries subjects regarding symptoms
time frame: Approximately 4 days post-intervention
measure: Control over target brain area
time frame: Approximately 4 days pre-intervention
description: Control task scans will be conducted in which subjects are cued to at times to increase activity in their target brain area and at other times to decrease activity in their target brain area. During both conditions they will be presented with symptom provoking images. The percent signal change in the BOLD signal in the target area during increase relative to decrease blocks will be used as the measure of control over the brain area.
measure: Control over the target brain area.
time frame: Approximately 4 days post-intervention
description: Control task scans will be conducted in which subjects are cued to at times to increase activity in their target brain area and at other times to decrease activity in their target brain area. During both conditions they will be presented with symptom provoking images. The percent signal change in the BOLD signal in the target area during increase relative to decrease blocks will be used as the measure of control over the brain area.
measure: Functional connectivity patterns in the brain
time frame: Approximately 4 days pre-intervention
description: Functional connectivity will be assessed based on temporal correlations in resting state functional imaging data.
measure: Functional connectivity patterns in the brain
time frame: Approximately 4 days post-intervention
description: Functional connectivity will be assessed based on temporal correlations in resting state functional imaging data.
measure: A modified version of the Yale-Brown Obsessive-Compulsive Symptom scale (Y-BOCS) will be used, that queries subjects regarding symptoms
time frame: Approximately 2 weeks post-intervention
measure: A modified version of the Yale-Brown Obsessive-Compulsive Symptom scale (Y-BOCS) will be used, that queries subjects regarding symptoms
time frame: Approximately 4 weeks post-intervention
measure: Average self-report of washing/checking anxiety to provocative images during a session in which they are instructed to control anxiety
time frame: Approximately 4 days pre-intervention
description: Subject instructed to control anxiety, shown provocative pictures and self-reports the anxiety they experience for each image. Responses averaged over session for a single number representing level of anxiety experienced despite efforts to control that anxiety.
measure: Average self-report of washing/checking anxiety to provocative images during a session in which they are instructed to control anxiety.
time frame: Approximately 4 days post-intervention
description: Subject instructed to control anxiety, shown provocative pictures and self-reports the anxiety they experience for each image. Responses averaged over session for a single number representing level of anxiety experienced despite efforts to control that anxiety.
arm group label: neurofeedback
arm group type: Experimental
description: Two imaging sessions of neurofeedback.
arm group label: control feedback
arm group type: Placebo Comparator
description: Two imaging sessions of feedback
intervention type: Behavioral
intervention name: neurofeedback
description: Subject provided with feedback of activity in target brain area in the form of a line graph. Cued to try to make the line go up at certain times and down at other times.
arm group label: neurofeedback
intervention type: Behavioral
intervention name: control feedback
description: Subject provided with a control/placebo type of feedback in the form of a line graph. Cued to try to make the line go up at certain times and down at other times.
arm group label: control feedback
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Michelle Hampson, PhD
role: Principal Investigator
affiliation: Yale School of Medicine
facility: 
country: United States
responsible party type: Sponsor
mesh term: Compulsive Personality Disorder
mesh term: Obsessive-Compulsive Disorder