<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/NCT01702077</url>
  </required_header>
  <id_info>
    <org_study_id>0206017435</org_study_id>
    <secondary_id>R01MH095789</secondary_id>
    <nct_id>NCT01702077</nct_id>
  </id_info>
  <brief_title>Neurofeedback for Tourette Syndrome</brief_title>
  <official_title>Neurofeedback of Activity in the Supplementary Motor Area for Tourette Syndrome</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 tic disorders to control activity in a region&#xD;
      of their brain that has been associated with the urge to tic. Patients will be given direct&#xD;
      feedback regarding activity in this brain area while they are undergoing functional magnetic&#xD;
      resonance imaging (fMRI) scanning, and will try to learn to control activity in the region&#xD;
      during these feedback sessions. In separate sessions, patients will be given sham feedback&#xD;
      based on the brain patterns of a prior subject rather than their own brain patterns. Our&#xD;
      primary hypothesis is that the biofeedback training will reduce their tic symptoms more than&#xD;
      the sham feedback.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">December 2017</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>Tic severity</measure>
    <time_frame>Tic severity assessed approximately half a week PRIOR TO beginning biofeedback/sham feedback.</time_frame>
    <description>A modified version of the Yale Global Tic Severity Scale (YGTSS) will be used, that queries subjects regarding symptoms over the last 3 days (rather than the 2 week period used in the standard scale). Total YGTSS score on this modified scale will be used as the measure of tic severity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tic severity</measure>
    <time_frame>Tic severity assessed approximately half a week AFTER completing biofeedback/sham feedback.</time_frame>
    <description>A modified version of the Yale Global Tic Severity Scale (YGTSS) will be used, that queries subjects regarding symptoms over the last 3 days (rather than the 2 week period used in the standard scale). Total YGTSS score on this modified scale will be used as the measure of tic severity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Control over target brain area</measure>
    <time_frame>Assessed approximately half a week BEFORE biofeedback/sham biofeedback.</time_frame>
    <description>Control task scans will be conducted in which subjects are cued to alternately increase and decrease activity in their target area without receiving any feedback. 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 target brain area</measure>
    <time_frame>Assessed approximately half a week AFTER biofeedback/sham biofeedback.</time_frame>
    <description>Control task scans will be conducted in which subjects are cued to alternately increase and decrease activity in their target area without receiving any feedback. 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>Assessed approximately half a week BEFORE biofeedback/sham biofeedback.</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>Assessed approximately half a week AFTER biofeedback/sham biofeedback.</time_frame>
    <description>Functional connectivity will be assessed based on temporal correlations in resting state functional imaging data.</description>
  </other_outcome>
  <other_outcome>
    <measure>Clinical improvement</measure>
    <time_frame>Clinical improvement will be assessed approximately half a week AFTER biofeedback/sham feedback</time_frame>
    <description>The Clinical Global Impression - Improvement scale will be used to assess improvement over the course of the biofeedback/sham feedback</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Tourette Syndrome</condition>
  <condition>Chronic Tic Disorder</condition>
  <arm_group>
    <arm_group_label>Neurofeedback first</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Neurofeedback then sham feedback</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham first</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sham feedback then neurofeedback</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Neurofeedback</intervention_name>
    <arm_group_label>Neurofeedback first</arm_group_label>
    <arm_group_label>Sham first</arm_group_label>
    <other_name>biofeedback</other_name>
    <other_name>real-time fMRI biofeedback</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sham feedback</intervention_name>
    <arm_group_label>Neurofeedback first</arm_group_label>
    <arm_group_label>Sham first</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of Tourette Syndrome or Chronic Tic Disorder&#xD;
&#xD;
          -  currently active tics&#xD;
&#xD;
          -  aged 11-19&#xD;
&#xD;
          -  ability to execute most common tics without moving head while lying on back&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Blindness (because feedback is provided visually)&#xD;
&#xD;
          -  Lifetime diagnosis of pervasive developmental disorder, bipolar disorder, or psychotic&#xD;
             disorder.&#xD;
&#xD;
          -  Presence of any serious psychiatric or psychosocial condition requiring initiation of&#xD;
             new treatment or change in current treatment.&#xD;
&#xD;
          -  Neurological conditions affecting central nervous system, with the exception that&#xD;
             predisposition to migraine will not be grounds for exclusion&#xD;
&#xD;
          -  Change in medication in the month prior to beginning the study&#xD;
&#xD;
          -  Unwillingness to keep medication stable over the course of the intervention&#xD;
&#xD;
          -  Full braces (but some retainers are OK)&#xD;
&#xD;
          -  Claustrophobia of a degree that they cannot comfortably be scanned&#xD;
&#xD;
          -  If common tics involve dramatic changes in breathing that could alter blood&#xD;
             oxygenation measurements&#xD;
&#xD;
          -  Inability to keep head still while executing most common tics&#xD;
&#xD;
          -  Inability to keep head still in mock scanner&#xD;
&#xD;
          -  Inability or unwillingness to understand or follow the instructions&#xD;
&#xD;
          -  Pregnancy or possible pregnancy&#xD;
&#xD;
          -  Subjects may also be excluded after the first magnetic resonance scan if we are unable&#xD;
             to localize a region of their supplementary motor area involved in tics - leaving us&#xD;
             without a target area for biofeedback.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>11 Years</minimum_age>
    <maximum_age>19 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michelle Hampson, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</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>August 2018</verification_date>
  <study_first_submitted>October 3, 2012</study_first_submitted>
  <study_first_submitted_qc>October 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 5, 2012</study_first_posted>
  <last_update_submitted>August 24, 2018</last_update_submitted>
  <last_update_submitted_qc>August 24, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>neurofeedback</keyword>
  <keyword>biofeedback</keyword>
  <keyword>real-time fMRI</keyword>
  <keyword>rt-fMRI</keyword>
  <keyword>functional connectivity</keyword>
  <keyword>fMRI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tourette Syndrome</mesh_term>
    <mesh_term>Tic Disorders</mesh_term>
    <mesh_term>Syndrome</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/NCT01702077
org study id: 0206017435
secondary id: R01MH095789
nct id: NCT01702077
lead sponsor: 
collaborator: 
has dmc: No
The aim of this study is to train patients with tic disorders to control activity in a region
      of their brain that has been associated with the urge to tic. Patients 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. In separate sessions, patients will be given sham feedback
      based on the brain patterns of a prior subject rather than their own brain patterns. Our
      primary hypothesis is that the biofeedback training will reduce their tic symptoms more than
      the sham feedback.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Tic severity
time frame: Tic severity assessed approximately half a week PRIOR TO beginning biofeedback/sham feedback.
description: A modified version of the Yale Global Tic Severity Scale (YGTSS) will be used, that queries subjects regarding symptoms over the last 3 days (rather than the 2 week period used in the standard scale). Total YGTSS score on this modified scale will be used as the measure of tic severity.
measure: Tic severity
time frame: Tic severity assessed approximately half a week AFTER completing biofeedback/sham feedback.
description: A modified version of the Yale Global Tic Severity Scale (YGTSS) will be used, that queries subjects regarding symptoms over the last 3 days (rather than the 2 week period used in the standard scale). Total YGTSS score on this modified scale will be used as the measure of tic severity.
measure: Control over target brain area
time frame: Assessed approximately half a week BEFORE biofeedback/sham biofeedback.
description: Control task scans will be conducted in which subjects are cued to alternately increase and decrease activity in their target area without receiving any feedback. 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 target brain area
time frame: Assessed approximately half a week AFTER biofeedback/sham biofeedback.
description: Control task scans will be conducted in which subjects are cued to alternately increase and decrease activity in their target area without receiving any feedback. 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: Assessed approximately half a week BEFORE biofeedback/sham biofeedback.
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: Assessed approximately half a week AFTER biofeedback/sham biofeedback.
description: Functional connectivity will be assessed based on temporal correlations in resting state functional imaging data.
measure: Clinical improvement
time frame: Clinical improvement will be assessed approximately half a week AFTER biofeedback/sham feedback
description: The Clinical Global Impression - Improvement scale will be used to assess improvement over the course of the biofeedback/sham feedback
arm group label: Neurofeedback first
arm group type: Experimental
description: Neurofeedback then sham feedback
arm group label: Sham first
arm group type: Experimental
description: Sham feedback then neurofeedback
intervention type: Procedure
intervention name: Neurofeedback
arm group label: Neurofeedback first
arm group label: Sham first
other name: biofeedback
other name: real-time fMRI biofeedback
intervention type: Procedure
intervention name: Sham feedback
arm group label: Neurofeedback first
arm group label: Sham first
criteria: 
gender: All
minimum age: 11 Years
maximum age: 19 Years
healthy volunteers: No
last name: Michelle Hampson, Ph.D.
role: Principal Investigator
affiliation: Yale University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Tourette Syndrome
mesh term: Tic Disorders
mesh term: Syndrome