<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/NCT02265315</url>
  </required_header>
  <id_info>
    <org_study_id>14-03265-FB UM</org_study_id>
    <nct_id>NCT02265315</nct_id>
  </id_info>
  <brief_title>Augmenting Treatment Effects of Voice Therapy in Parkinson Disease</brief_title>
  <official_title>Augmenting Treatment Effects of Voice Therapy in Parkinson Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Le Bonheur Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Michael J. Fox Foundation for Parkinson's Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Tennessee</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Memphis</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Le Bonheur Children's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the impact of a non-invasive brain stimulation&#xD;
      technique called transcranial magnetic stimulation (TMS) on voice/speech treatment in people&#xD;
      with Parkinson's Disease (PD), through the use of speech and voice analysis, examination of&#xD;
      voice box, and brain imaging methods.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Effective treatment of the speech disorder in IPD is as important as the optimal control of&#xD;
      limb motor symptoms. Presently, the Lee Silverman Voice Treatment (LSVTÒ LOUD) - is a time&#xD;
      intensive behavioral treatment for Parkinson's hypophonia. Facilitatory TMS is a safe and a&#xD;
      complimentary stimulation technique. Brain imaging has also identified suitable target brain&#xD;
      regions that are readily accessible to TMS. This combined treatment modality approach should&#xD;
      be more effective and efficient the LSVT alone.&#xD;
&#xD;
      The study will enroll patients with Parkinson's disease with moderate to severe hypophonia. A&#xD;
      total of 36 patients will be recruited over 3 years and divided into 3 groups (n=12 each).&#xD;
      The three cohorts are: 1. LSVT +sham TMS; 2. LSVT +left rTMS and 3. LSVT + right rTMS.&#xD;
&#xD;
      This is a longitudinal double blind randomized controlled clinical trial. All investigators&#xD;
      and study personnel will be blind to the study except for the PI responsible for TMS (Dr.&#xD;
      Narayana). The entire protocol occurs over 19 weeks. During the first week, the participants&#xD;
      will be screened, consented. During the second week, baseline behavioral and imaging data&#xD;
      will be collected. Next, the patients will be randomized to one of the three treatment&#xD;
      groups. Then the patients will enter a 4-week treatment phase, where they will receive&#xD;
      TMS/sham TMS and LSVT 4 days a week for 4 weeks. During the seventh week, patients will&#xD;
      undergo post treatment behavioral and imaging assessments. Then the patients will return in&#xD;
      week 19 to complete the follow up behavioral measures and imaging session.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">June 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</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>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical assessment:</measure>
    <time_frame>19 weeks</time_frame>
    <description>Voice intensity and overall voice quality</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient assessment:</measure>
    <time_frame>19 weeks</time_frame>
    <description>10-item Voice related Quality of Life Scale (V-RQOL)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Physiological assessment:</measure>
    <time_frame>19 weeks</time_frame>
    <description>Vocal fold function; Changes in brain activation: at the site of TMS stimulation and the speech motor network; and Functional connectivity within the speech motor network</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical assessment</measure>
    <time_frame>19 weeks</time_frame>
    <description>intelligibility and articulation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient self-assessment</measure>
    <time_frame>19 weeks</time_frame>
    <description>visual analog scaling of speech intelligibility</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>LSVT +sham TMS</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Lee Silverman Voice Treatment (LSVT) and Transcranial Magnetic Stimulation (TMS)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LSVT +left rTMS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Lee Silverman Voice Treatment (LSVT) and Transcranial Magnetic Stimulation (TMS) applied to left side of head</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LSVT + right rTMS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Lee Silverman Voice Treatment (LSVT) and Transcranial Magnetic Stimulation (TMS) applied to right side of brain</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Transcranial Magnetic Stimulation</intervention_name>
    <description>Treament adjuvant applied to accelerate vocal motor learning and overall voice improvement</description>
    <arm_group_label>LSVT + right rTMS</arm_group_label>
    <arm_group_label>LSVT +left rTMS</arm_group_label>
    <other_name>TMS</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Lee Silverman Voice Treatment</intervention_name>
    <description>Time intensive behavioral treatment for Parkinson's hypophonia</description>
    <arm_group_label>LSVT + right rTMS</arm_group_label>
    <arm_group_label>LSVT +left rTMS</arm_group_label>
    <arm_group_label>LSVT +sham TMS</arm_group_label>
    <other_name>LSVT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals with Idiopathic Parkinson's disease (IPD) between the ages of 45 and 80&#xD;
             years with moderate to severe hypophonia&#xD;
&#xD;
          -  None or mild cognitive impairment or depression&#xD;
&#xD;
          -  Stable medication therapy for at least 3 months. Must be &quot;optimally medicated&quot; at the&#xD;
             start of the study. This means that there should be no change in mediction type or&#xD;
             dosage in 3 months prior to enrolling in the study. The medications should not be&#xD;
             causing significant or serious advese effects&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of drug abuse or neurological condition other than or in addition to IPD (for&#xD;
             example stroke)&#xD;
&#xD;
          -  Individuals with advanced IPD (stage V) or who had LSVT within 3 years&#xD;
&#xD;
          -  Pregnant females&#xD;
&#xD;
          -  History of seizures, history of major head trauma, metal objects implanted in the&#xD;
             head, ferrous metal filings in the eye, brain damage, inflammation of the brain,&#xD;
             cardiac pacemaker, implanted medication pump, cardiac lines, heart disease, currently&#xD;
             taking certain types of medication for depression or seizures (tricyclic&#xD;
             antidepressants or neuroleptics which lower seizure threshold&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shalini Narayana, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>LeBonheur Children's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>LeBonheur Children Hospital</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://foxtrialfinder.michaeljfox.org/trial/3885/</url>
    <description>Michael J. Fox Trial Finder</description>
  </link>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>October 9, 2014</study_first_submitted>
  <study_first_submitted_qc>October 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>September 21, 2020</last_update_submitted>
  <last_update_submitted_qc>September 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Le Bonheur Children's Hospital</investigator_affiliation>
    <investigator_full_name>James W. Wheless</investigator_full_name>
    <investigator_title>Shalini Narayana, Ph.D.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02265315
org study id: 14-03265-FB UM
nct id: NCT02265315
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of this study is to evaluate the impact of a non-invasive brain stimulation
      technique called transcranial magnetic stimulation (TMS) on voice/speech treatment in people
      with Parkinson's Disease (PD), through the use of speech and voice analysis, examination of
      voice box, and brain imaging methods.
Effective treatment of the speech disorder in IPD is as important as the optimal control of
      limb motor symptoms. Presently, the Lee Silverman Voice Treatment (LSVTÒ LOUD) - is a time
      intensive behavioral treatment for Parkinson's hypophonia. Facilitatory TMS is a safe and a
      complimentary stimulation technique. Brain imaging has also identified suitable target brain
      regions that are readily accessible to TMS. This combined treatment modality approach should
      be more effective and efficient the LSVT alone.

      The study will enroll patients with Parkinson's disease with moderate to severe hypophonia. A
      total of 36 patients will be recruited over 3 years and divided into 3 groups (n=12 each).
      The three cohorts are: 1. LSVT +sham TMS; 2. LSVT +left rTMS and 3. LSVT + right rTMS.

      This is a longitudinal double blind randomized controlled clinical trial. All investigators
      and study personnel will be blind to the study except for the PI responsible for TMS (Dr.
      Narayana). The entire protocol occurs over 19 weeks. During the first week, the participants
      will be screened, consented. During the second week, baseline behavioral and imaging data
      will be collected. Next, the patients will be randomized to one of the three treatment
      groups. Then the patients will enter a 4-week treatment phase, where they will receive
      TMS/sham TMS and LSVT 4 days a week for 4 weeks. During the seventh week, patients will
      undergo post treatment behavioral and imaging assessments. Then the patients will return in
      week 19 to complete the follow up behavioral measures and imaging session.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Clinical assessment:
time frame: 19 weeks
description: Voice intensity and overall voice quality
measure: Patient assessment:
time frame: 19 weeks
description: 10-item Voice related Quality of Life Scale (V-RQOL)
measure: Physiological assessment:
time frame: 19 weeks
description: Vocal fold function; Changes in brain activation: at the site of TMS stimulation and the speech motor network; and Functional connectivity within the speech motor network
measure: Clinical assessment
time frame: 19 weeks
description: intelligibility and articulation
measure: Patient self-assessment
time frame: 19 weeks
description: visual analog scaling of speech intelligibility
arm group label: LSVT +sham TMS
arm group type: Sham Comparator
description: Lee Silverman Voice Treatment (LSVT) and Transcranial Magnetic Stimulation (TMS)
arm group label: LSVT +left rTMS
arm group type: Active Comparator
description: Lee Silverman Voice Treatment (LSVT) and Transcranial Magnetic Stimulation (TMS) applied to left side of head
arm group label: LSVT + right rTMS
arm group type: Active Comparator
description: Lee Silverman Voice Treatment (LSVT) and Transcranial Magnetic Stimulation (TMS) applied to right side of brain
intervention type: Other
intervention name: Transcranial Magnetic Stimulation
description: Treament adjuvant applied to accelerate vocal motor learning and overall voice improvement
arm group label: LSVT + right rTMS
arm group label: LSVT +left rTMS
other name: TMS
intervention type: Behavioral
intervention name: Lee Silverman Voice Treatment
description: Time intensive behavioral treatment for Parkinson's hypophonia
arm group label: LSVT + right rTMS
arm group label: LSVT +left rTMS
arm group label: LSVT +sham TMS
other name: LSVT
criteria: 
gender: All
minimum age: 45 Years
maximum age: 80 Years
healthy volunteers: No
last name: Shalini Narayana, PhD
role: Principal Investigator
affiliation: LeBonheur Children's Hospital
facility: 
country: United States
url: https://foxtrialfinder.michaeljfox.org/trial/3885/
description: Michael J. Fox Trial Finder
responsible party type: Principal Investigator
investigator affiliation: Le Bonheur Children's Hospital
investigator full name: James W. Wheless
investigator title: Shalini Narayana, Ph.D.
mesh term: Parkinson Disease
sharing ipd: Yes