<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/NCT03028324</url>
  </required_header>
  <id_info>
    <org_study_id>20161125</org_study_id>
    <nct_id>NCT03028324</nct_id>
  </id_info>
  <brief_title>Transcranial Magnetic Stimulation (TMS) for Primary Progressive Apraxia of Speech (PPAOS)</brief_title>
  <official_title>Investigating the Use of Transcranial Magnetic Stimulation (TMS) for Primary Progressive Apraxia of Speech (PPAOS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Miami</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Miami</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>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the influence of transcranial magnetic stimulation&#xD;
      (TMS) on speech performance in individuals with primary progressive apraxia of speech.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Apraxia of speech (AOS) is a motor speech disorder affecting the programming of motor speech&#xD;
      production. It is characterized by the impaired ability to coordinate the sequential,&#xD;
      articulatory movements necessary to produce speech sound. It can result from insult to the&#xD;
      brain, such as in stroke, or as the presenting sign/symptom of another neurodegenerative&#xD;
      disease.&#xD;
&#xD;
      TMS is a neurostimulation technique which has been shown to modulate cortical excitability in&#xD;
      a non-invasive manner, and has been associated with positive outcomes in a variety of&#xD;
      neurological and psychological disorders.There is evidence to support the role of TMS in&#xD;
      individuals with primary progressive aphasias. In addition, there is a a case report&#xD;
      suggesting an improvement in speech following TMS in an individual with primary progressive&#xD;
      AOS. This study is being undertaken to further examine the role of TMS in primary progressive&#xD;
      AOS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Difficulty recruiting participants and lost personnel.&#xD;
  </why_stopped>
  <start_date type="Actual">August 9, 2017</start_date>
  <completion_date type="Actual">November 13, 2018</completion_date>
  <primary_completion_date type="Actual">November 13, 2018</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Speech Performance</measure>
    <time_frame>Baseline, 4 weeks</time_frame>
    <description>Apraxia of Speech Rating Scale has a total range from 0-64, with lower scores indicating lower impairment and higher scores indicating higher impairment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Motor Cortex Excitability</measure>
    <time_frame>Baseline, 4 weeks</time_frame>
    <description>Motor cortex excitability will be assessed with single-pulse TMS</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Apraxia Speech</condition>
  <arm_group>
    <arm_group_label>Transcranial Magnetic Stimulation (TMS)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Non-invasive brain stimulation, high frequency repetitive TMS delivered in 10 sessions over a 2-week period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Transcranial Magnetic Stimulation (TMS)</intervention_name>
    <description>Non-invasive brain stimulation, high frequency repetitive TMS delivered in 10 sessions over a 2-week period.</description>
    <arm_group_label>Transcranial Magnetic Stimulation (TMS)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults ages 18 and above who are able to consent&#xD;
&#xD;
          -  Diagnosis of primary progressive apraxia of speech based on neurological evaluation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any uncontrolled medical condition expected to limit life expectancy or interfere with&#xD;
             participation in the trial (i.e. unstable cancer, severe depression or anxiety by&#xD;
             DSM-IV criteria)&#xD;
&#xD;
          -  Abnormal stress test, as determined by the treating physician (unless cardiology&#xD;
             clearance provided)&#xD;
&#xD;
          -  Active substance abuse or alcohol dependence&#xD;
&#xD;
          -  Uncorrected vision or hearing deficits that would preclude administration of the&#xD;
             cognitive measures&#xD;
&#xD;
          -  Unwilling or unable to provide written informed consent&#xD;
&#xD;
          -  History of fainting spells of unknown or undetermined etiology that might constitute&#xD;
             seizures&#xD;
&#xD;
          -  History of seizures, diagnosis of epilepsy, history of abnormal (epileptiform) EEG or&#xD;
             family history of treatment resistant epilepsy&#xD;
&#xD;
          -  No medication is an absolute exclusion from TMS. Medications will be reviewed by the&#xD;
             responsible MD and a decision about inclusion will be made based on the following:&#xD;
&#xD;
               -  The subject's past medical history, drug dose, history of recent medication&#xD;
                  changes or duration of treatment, and combination with other CNS active drugs.&#xD;
&#xD;
               -  The published TMS guidelines review medications to be considered with TMS&#xD;
&#xD;
          -  Any metal in the brain, skull or elsewhere unless approved by the responsible MD&#xD;
&#xD;
          -  Any medical devices (i.e. Cardiac pacemaker, deep brain stimulator, medication&#xD;
             infusion pump, cochlear implant, vagal nerve stimulator) unless otherwise approved by&#xD;
             the responsible MD&#xD;
&#xD;
          -  Substance abuse or dependence within the past six months&#xD;
&#xD;
          -  Absence of corticospinal functional integrity&#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>Joyce R Gomes Osman, PT, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Univeristy of Miami Miller School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Miami Miller School of Medicine</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>January 16, 2017</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <results_first_submitted>February 24, 2020</results_first_submitted>
  <results_first_submitted_qc>May 22, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">May 26, 2020</results_first_posted>
  <last_update_submitted>May 22, 2020</last_update_submitted>
  <last_update_submitted_qc>May 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Miami</investigator_affiliation>
    <investigator_full_name>Joyce Rios Gomes Osman</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Apraxias</mesh_term>
    <mesh_term>Aphasia, Primary Progressive</mesh_term>
    <mesh_term>Pick Disease of the Brain</mesh_term>
    <mesh_term>Frontotemporal Dementia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 17, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/24/NCT03028324/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Transcranial Magnetic Stimulation (TMS)</title>
          <description>Non-invasive brain stimulation, high frequency repetitive TMS delivered in 10 sessions over a 2-week period.&#xD;
Transcranial Magnetic Stimulation (TMS): Non-invasive brain stimulation, high frequency repetitive TMS delivered in 10 sessions over a 2-week period.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </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>Transcranial Magnetic Stimulation (TMS)</title>
          <description>Non-invasive brain stimulation, high frequency repetitive TMS delivered in 10 sessions over a 2-week period.&#xD;
Transcranial Magnetic Stimulation (TMS): Non-invasive brain stimulation, high frequency repetitive TMS delivered in 10 sessions over a 2-week period.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="4"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </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="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Speech Performance</title>
        <description>Apraxia of Speech Rating Scale has a total range from 0-64, with lower scores indicating lower impairment and higher scores indicating higher impairment.</description>
        <time_frame>Baseline, 4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Transcranial Magnetic Stimulation (TMS)</title>
            <description>Non-invasive brain stimulation, high frequency repetitive TMS delivered in 10 sessions over a 2-week period.&#xD;
Transcranial Magnetic Stimulation (TMS): Non-invasive brain stimulation, high frequency repetitive TMS delivered in 10 sessions over a 2-week period.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Speech Performance</title>
          <description>Apraxia of Speech Rating Scale has a total range from 0-64, with lower scores indicating lower impairment and higher scores indicating higher impairment.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.75" spread="8.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Motor Cortex Excitability</title>
        <description>Motor cortex excitability will be assessed with single-pulse TMS</description>
        <time_frame>Baseline, 4 weeks</time_frame>
        <population>The change in motor excitability data is not available due to the fact that post intervention data was not collected.</population>
        <group_list>
          <group group_id="O1">
            <title>Transcranial Magnetic Stimulation (TMS)</title>
            <description>Non-invasive brain stimulation, high frequency repetitive TMS delivered in 10 sessions over a 2-week period.&#xD;
Transcranial Magnetic Stimulation (TMS): Non-invasive brain stimulation, high frequency repetitive TMS delivered in 10 sessions over a 2-week period.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Motor Cortex Excitability</title>
          <description>Motor cortex excitability will be assessed with single-pulse TMS</description>
          <population>The change in motor excitability data is not available due to the fact that post intervention data was not collected.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>4 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Transcranial Magnetic Stimulation (TMS)</title>
          <description>Non-invasive brain stimulation, high frequency repetitive TMS delivered in 10 sessions over a 2-week period.&#xD;
Transcranial Magnetic Stimulation (TMS): Non-invasive brain stimulation, high frequency repetitive TMS delivered in 10 sessions over a 2-week period.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
              </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>Joyce Rios Gomes-Osman</name_or_title>
      <organization>University of Miami</organization>
      <phone>305-284-2632</phone>
      <email>j.gomes@miami.edu</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/NCT03028324
org study id: 20161125
nct id: NCT03028324
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The purpose of this study is to assess the influence of transcranial magnetic stimulation
      (TMS) on speech performance in individuals with primary progressive apraxia of speech.
Apraxia of speech (AOS) is a motor speech disorder affecting the programming of motor speech
      production. It is characterized by the impaired ability to coordinate the sequential,
      articulatory movements necessary to produce speech sound. It can result from insult to the
      brain, such as in stroke, or as the presenting sign/symptom of another neurodegenerative
      disease.

      TMS is a neurostimulation technique which has been shown to modulate cortical excitability in
      a non-invasive manner, and has been associated with positive outcomes in a variety of
      neurological and psychological disorders.There is evidence to support the role of TMS in
      individuals with primary progressive aphasias. In addition, there is a a case report
      suggesting an improvement in speech following TMS in an individual with primary progressive
      AOS. This study is being undertaken to further examine the role of TMS in primary progressive
      AOS.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Change in Speech Performance
time frame: Baseline, 4 weeks
description: Apraxia of Speech Rating Scale has a total range from 0-64, with lower scores indicating lower impairment and higher scores indicating higher impairment.
measure: Change in Motor Cortex Excitability
time frame: Baseline, 4 weeks
description: Motor cortex excitability will be assessed with single-pulse TMS
arm group label: Transcranial Magnetic Stimulation (TMS)
arm group type: Experimental
description: Non-invasive brain stimulation, high frequency repetitive TMS delivered in 10 sessions over a 2-week period.
intervention type: Device
intervention name: Transcranial Magnetic Stimulation (TMS)
description: Non-invasive brain stimulation, high frequency repetitive TMS delivered in 10 sessions over a 2-week period.
arm group label: Transcranial Magnetic Stimulation (TMS)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Joyce R Gomes Osman, PT, PhD
role: Principal Investigator
affiliation: Univeristy of Miami Miller School of Medicine
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Miami
investigator full name: Joyce Rios Gomes Osman
investigator title: Assistant Professor
mesh term: Apraxias
mesh term: Aphasia, Primary Progressive
mesh term: Pick Disease of the Brain
mesh term: Frontotemporal Dementia
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 