<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/NCT02236767</url>
  </required_header>
  <id_info>
    <org_study_id>DIEF003523.4</org_study_id>
    <nct_id>NCT02236767</nct_id>
  </id_info>
  <brief_title>Transcranial Magnetic Stimulation Treatment of Hoarding Disorder</brief_title>
  <official_title>Transcranial Magnetic Stimulation Treatment of Hoarding Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hartford Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Neuronetics</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hartford Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is multiple baseline study including up to three participants with a primary diagnosis&#xD;
      of hoarding disorder. All patients will receive unblinded repetitive transcranial magnetic&#xD;
      stimulation study intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study assessments will be conducted at pre-baseline, weekly during baseline assessment (until&#xD;
      a stable baseline is established, but not less than 2, 4, and 6 weeks for patients&#xD;
      respectively), weekly during treatment, and at post-treatment. Magnetic resonance imaging&#xD;
      (MRI) will be competed at pre-baseline, pre-treatment, and post-treatment. Treatment will&#xD;
      entail daily (5 days/week) sessions of repetitive transcranial magnetic stimulation using the&#xD;
      Neurostar Therapy System for 6 weeks employing right-sided, low frequency stimulation (1 Hz,&#xD;
      900 pulses/session for 30 sessions, 27,000 total pulses, intensity at 90% of the passive&#xD;
      motor threshold) to the dorsolateral prefrontal cortex (DLPFC). Neuronavigation will direct&#xD;
      coil placement over the DLPFC based upon structural MRI.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</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>The Saving Inventory-Revised (SI-R) Total Score</measure>
    <time_frame>Pre-baseline, Post-baseline/Pre-treatment, Post-treatment, 2-Month Follow-up</time_frame>
    <description>The Saving Inventory-Revised (SI-R) is a self-report measure which includes 23 items assessing the severity of hoarding symptoms including difficulty discarding, acquiring, and clutter. The 23 items are added for a total score which ranges from 0 to 92 and with higher score indicating more severe hoarding symptoms.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Hoarding</condition>
  <arm_group>
    <arm_group_label>rTMS Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>NeuroStar Transcranial Magnetic Stimulation Therapy System</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Neurostar Transcranial Magnetic Stimulation Therapy System</intervention_name>
    <description>Treatment will entail daily (5 days/week) sessions of repetitive transcranial magnetic stimulation for 6 weeks employing right-sided, low frequency stimulation (1 Hz, 900 pulses/session for 30 sessions, 27,000 total pulses, intensity at 90% of the passive motor threshold) to the dorsolateral prefrontal cortex (DLPFC).</description>
    <arm_group_label>rTMS Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with hoarding disorder as primary disorder&#xD;
&#xD;
          -  Clinical Global Impression Score &gt; 3&#xD;
&#xD;
          -  Saving Inventory-Revised score &gt; 39&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any contraindication for participation in magnetic resonance imaging or transcranial&#xD;
             magnetic stimulation&#xD;
&#xD;
          -  Severe and/or unstable medical or psychiatric condition that require immediate medical&#xD;
             attention&#xD;
&#xD;
          -  Diagnosed with current major depressive episode&#xD;
&#xD;
          -  Currently taking psychiatric medication&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gretchen J Diefenbach, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hartford Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hartford Hospital</name>
      <address>
        <city>Hartford</city>
        <state>Connecticut</state>
        <zip>06106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>September 4, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2014</study_first_posted>
  <results_first_submitted>March 25, 2016</results_first_submitted>
  <results_first_submitted_qc>August 15, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">October 6, 2016</results_first_posted>
  <last_update_submitted>August 15, 2016</last_update_submitted>
  <last_update_submitted_qc>August 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 6, 2016</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>Hoarding Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>TMS Therapy</title>
          <description>NeuroStar TMS Therapy System&#xD;
Neurostar TMS Therapy System: Treatment will entail daily (5 days/week) sessions of rTMS for 6 weeks employing right-sided, low frequency stimulation (1 Hz, 900 pulses/session for 30 sessions, 27,000 total pulses, intensity at 90% of the passive motor threshold) to the dorsolateral prefrontal cortex (DLPFC).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>TMS Therapy</title>
          <description>NeuroStar TMS Therapy System&#xD;
Neurostar TMS Therapy System: Treatment will entail daily (5 days/week) sessions of rTMS for 6 weeks employing right-sided, low frequency stimulation (1 Hz, 900 pulses/session for 30 sessions, 27,000 total pulses, intensity at 90% of the passive motor threshold) to the dorsolateral prefrontal cortex (DLPFC).</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>The Saving Inventory-Revised (SI-R) Total Score</title>
        <description>The Saving Inventory-Revised (SI-R) is a self-report measure which includes 23 items assessing the severity of hoarding symptoms including difficulty discarding, acquiring, and clutter. The 23 items are added for a total score which ranges from 0 to 92 and with higher score indicating more severe hoarding symptoms.</description>
        <time_frame>Pre-baseline, Post-baseline/Pre-treatment, Post-treatment, 2-Month Follow-up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>rTMS Treatment</title>
            <description>NeuroStar TMS Therapy System&#xD;
Neurostar TMS Therapy System: Treatment will entail daily (5 days/week) sessions of rTMS for 6 weeks employing right-sided, low frequency stimulation (1 Hz, 900 pulses/session for 30 sessions, 27,000 total pulses, intensity at 90% of the passive motor threshold) to the dorsolateral prefrontal cortex (DLPFC).</description>
          </group>
        </group_list>
        <measure>
          <title>The Saving Inventory-Revised (SI-R) Total Score</title>
          <description>The Saving Inventory-Revised (SI-R) is a self-report measure which includes 23 items assessing the severity of hoarding symptoms including difficulty discarding, acquiring, and clutter. The 23 items are added for a total score which ranges from 0 to 92 and with higher score indicating more severe hoarding symptoms.</description>
          <units>units on a scale</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-baselne</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-baseline/Pre-treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2-Month Follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 weeks</time_frame>
      <desc>an adverse events checklist was administered</desc>
      <group_list>
        <group group_id="E1">
          <title>TMS Therapy</title>
          <description>NeuroStar TMS Therapy System&#xD;
Neurostar TMS Therapy System: Treatment will entail daily (5 days/week) sessions of rTMS for 6 weeks employing right-sided, low frequency stimulation (1 Hz, 900 pulses/session for 30 sessions, 27,000 total pulses, intensity at 90% of the passive motor threshold) to the dorsolateral prefrontal cortex (DLPFC).</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>eye twitch</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>pin prick sensation at treatment site</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>pain discomfort at the treatment site</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>tapping sound</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Gretchen Diefenbach</name_or_title>
      <organization>Hartford Hospital</organization>
      <phone>860-545-7396</phone>
      <email>gretchen.diefenbach@hhchealth.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02236767
org study id: DIEF003523.4
nct id: NCT02236767
lead sponsor: 
collaborator: 
has dmc: No
This is multiple baseline study including up to three participants with a primary diagnosis
      of hoarding disorder. All patients will receive unblinded repetitive transcranial magnetic
      stimulation study intervention.
Study assessments will be conducted at pre-baseline, weekly during baseline assessment (until
      a stable baseline is established, but not less than 2, 4, and 6 weeks for patients
      respectively), weekly during treatment, and at post-treatment. Magnetic resonance imaging
      (MRI) will be competed at pre-baseline, pre-treatment, and post-treatment. Treatment will
      entail daily (5 days/week) sessions of repetitive transcranial magnetic stimulation using the
      Neurostar Therapy System for 6 weeks employing right-sided, low frequency stimulation (1 Hz,
      900 pulses/session for 30 sessions, 27,000 total pulses, intensity at 90% of the passive
      motor threshold) to the dorsolateral prefrontal cortex (DLPFC). Neuronavigation will direct
      coil placement over the DLPFC based upon structural MRI.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The Saving Inventory-Revised (SI-R) Total Score
time frame: Pre-baseline, Post-baseline/Pre-treatment, Post-treatment, 2-Month Follow-up
description: The Saving Inventory-Revised (SI-R) is a self-report measure which includes 23 items assessing the severity of hoarding symptoms including difficulty discarding, acquiring, and clutter. The 23 items are added for a total score which ranges from 0 to 92 and with higher score indicating more severe hoarding symptoms.
arm group label: rTMS Treatment
arm group type: Experimental
description: NeuroStar Transcranial Magnetic Stimulation Therapy System
intervention type: Device
intervention name: Neurostar Transcranial Magnetic Stimulation Therapy System
description: Treatment will entail daily (5 days/week) sessions of repetitive transcranial magnetic stimulation for 6 weeks employing right-sided, low frequency stimulation (1 Hz, 900 pulses/session for 30 sessions, 27,000 total pulses, intensity at 90% of the passive motor threshold) to the dorsolateral prefrontal cortex (DLPFC).
arm group label: rTMS Treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gretchen J Diefenbach, Ph.D.
role: Principal Investigator
affiliation: Hartford Hospital
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hoarding Disorder
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 