<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/NCT02199106</url>
  </required_header>
  <id_info>
    <org_study_id>Ti-cTBS</org_study_id>
    <nct_id>NCT02199106</nct_id>
  </id_info>
  <brief_title>Effectiveness of Neuronavigated Continuous Theta Burst Stimulation of the Left Heschl's Gyrus in Chronic Tinnitus</brief_title>
  <official_title>Effectiveness of Neuronavigated Continuous Theta Burst Stimulation of the Left Heschl's Gyrus in Chronic Tinnitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Regensburg</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Wuerzburg</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital Tuebingen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital Muenster</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Regensburg</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Neuronavigated continuous theta burst stimulation of the left Heschl's gyrus is used to&#xD;
      modulate auditory cortex activity and plasticity contributing to the perception and distress&#xD;
      of chronic tinnitus.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Tinnitus is the phantom auditory perception of sound in the absence of an external or&#xD;
      internal acoustic stimulus. It is a frequent problem which can interfere significantly with&#xD;
      the ability to lead a normal life. One significant modulator of tinnitus is stress. Tinnitus&#xD;
      has been shown to be generated in the brain, as a result of functional reorganization of&#xD;
      auditory neural pathways and the central auditory system. Repetitive transcranial magnetic&#xD;
      stimulation (rTMS) is also effective in treatment of tinnitus with moderate effect size.&#xD;
      Pilot data were positive for low-frequency rTMS applied to the temporal and temporoparietal&#xD;
      areas. Continuous theta burst stimulation (cTBS) is a new protocol of rTMS with a possible&#xD;
      superior effect in contrast to low-frequency rTMS. Also anatomical neuronavigation might&#xD;
      increase the efficacy of rTMS due to exact targeting of the primary auditory cortex. Thus,&#xD;
      the aim of this study is the evaluation of the clinical efficacy of neuronavigated left-sided&#xD;
      cTBS in chronic tinnitus in a randomised sham-controlled two-arm design.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2009</start_date>
  <completion_date type="Actual">May 2011</completion_date>
  <primary_completion_date type="Actual">March 2011</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in tinnitus questionnaire total score (contrast baseline (-day 3) versus end of treatment (day 10))</measure>
    <time_frame>-day 3; day 10</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of tinnitus questionaire total score (all baseline (-week 2, - week1, - day 3) vs. all follow-up visits (day 6, day 10, week 1, week 3, week 8))</measure>
    <time_frame>-week 2; - week1; - day 3; day 6; day 10; week 1; week 3; week 8</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of tinnitus handicap inventory total score (all baseline (-week 2, - week1, - day 3) vs. all follow-up visits (day 6, day 10, week 1, week 3, week 8))</measure>
    <time_frame>-week 2; - week1; - day 3; day 6; day 10; week 1; week 3; week 8</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of tinnitus numeric rating scales (all baseline (-week 2, - week1, - day 3) vs. all follow-up visits (day 6, day 10, week 1, week 3, week 8))</measure>
    <time_frame>-week 2; - week1; - day 3; day 6; day 10; week 1; week 3; week 8</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of depressive symptoms as measured by the Beck Depression Inventory II (BDI) (baseline visit -week 2 vs. all follow-up visits (day 6, day 10, week 1, week 3, week 8))</measure>
    <time_frame>-week 2; day 6; day 10; week 1; week 3; week 8</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Chronic Tinnitus</condition>
  <arm_group>
    <arm_group_label>Left temporal verum cTBS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Continuous theta burst stimulation (MC-B70, MagPro,MagOption, Medtronic, Germany): 400 triplets of stimuli (triplets with 50Hz) at an frequency of 5Hz (in sum 1200 stimuli) with a break after 200 bursts over the left Heschl's gyrus targeted with anatomical neuronavigation (Localite, Germany); 30% maximum stimulator output (each session)&#xD;
Intervention: Left temporal verum cTBS</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Left temporal placebo cTBS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Continuous theta burst stimulation (MC-B70, MagPro,MagOption, Medtronic, Germany): 400 triplets of stimuli (triplets with 50Hz) at an frequency of 5Hz (in sum 1200 stimuli) with a break after 200 bursts over the left Heschl's gyrus targeted with anatomical neuronavigation (Localite, Germany); 30% maximum stimulator output (each session); coil tilted by 45° over both wings&#xD;
Intervention: Left temporal placebo cTBS</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Left temporal verum cTBS</intervention_name>
    <description>Continuous theta burst stimulation (MC-B70, MagPro,MagOption, Medtronic, Germany): 400 triplets of stimuli (triplets with 50Hz) at an frequency of 5Hz (in sum 1200 stimuli) with a break after 200 bursts over the left Heschl's gyrus targeted with anatomical neuronavigation (Localite, Germany); 30% maximum stimulator output (each session)&#xD;
Arms: Left temporal verum cTBS</description>
    <arm_group_label>Left temporal verum cTBS</arm_group_label>
    <other_name>MC-B70, MagPro,MagOption, Medtronic, Germany</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Left temporal placebo cTBS</intervention_name>
    <description>Continuous theta burst stimulation (MC-B70, MagPro,MagOption, Medtronic, Germany): 400 triplets of stimuli (triplets with 50Hz) at an frequency of 5Hz (in sum 1200 stimuli) with a break after 200 bursts over the left Heschl's gyrus targeted with anatomical neuronavigation (Localite, Germany); 30% maximum stimulator output (each session); coil tilted by 45° over both wings&#xD;
Arms: Left temporal placebo cTBS</description>
    <arm_group_label>Left temporal placebo cTBS</arm_group_label>
    <other_name>MC-B70, MagPro,MagOption, Medtronic, Germany</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of bothersome, subjective chronic tinnitus&#xD;
&#xD;
          -  Duration of tinnitus more than 6 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Objective tinnitus&#xD;
&#xD;
          -  Treatable cause of the tinnitus&#xD;
&#xD;
          -  Involvement in other treatments for tinnitus at the same time&#xD;
&#xD;
          -  Clinically relevant psychiatric comorbidity&#xD;
&#xD;
          -  Clinically relevant unstable internal or neurological comorbidity&#xD;
&#xD;
          -  History of or evidence of significant brain malformation or neoplasm, head injury&#xD;
&#xD;
          -  Cerebral vascular events&#xD;
&#xD;
          -  Neurodegenerative disorder affecting the brain or prior brain surgery&#xD;
&#xD;
          -  Metal objects in and around body that can not be removed&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Alcohol or drug abuse&#xD;
&#xD;
          -  acute or chronic inflammation of the middle ear, Meniere diseases, sudden idiopathic&#xD;
             hearing loss, fluctuating hearing&#xD;
&#xD;
          -  history of seizures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Berthold Langguth</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Regensburg</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Muenster</name>
      <address>
        <city>Muenster</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Regensburg - Dept of Psychiatry</name>
      <address>
        <city>Regensburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Tuebingen</name>
      <address>
        <city>Tuebingen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Wuerzburg</name>
      <address>
        <city>Wuerzburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 22, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 24, 2014</study_first_posted>
  <last_update_submitted>July 23, 2014</last_update_submitted>
  <last_update_submitted_qc>July 23, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 24, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Regensburg</investigator_affiliation>
    <investigator_full_name>Berthold Langguth, MD, Ph.D.</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tinnitus</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/NCT02199106
org study id: Ti-cTBS
nct id: NCT02199106
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
Neuronavigated continuous theta burst stimulation of the left Heschl's gyrus is used to
      modulate auditory cortex activity and plasticity contributing to the perception and distress
      of chronic tinnitus.
Tinnitus is the phantom auditory perception of sound in the absence of an external or
      internal acoustic stimulus. It is a frequent problem which can interfere significantly with
      the ability to lead a normal life. One significant modulator of tinnitus is stress. Tinnitus
      has been shown to be generated in the brain, as a result of functional reorganization of
      auditory neural pathways and the central auditory system. Repetitive transcranial magnetic
      stimulation (rTMS) is also effective in treatment of tinnitus with moderate effect size.
      Pilot data were positive for low-frequency rTMS applied to the temporal and temporoparietal
      areas. Continuous theta burst stimulation (cTBS) is a new protocol of rTMS with a possible
      superior effect in contrast to low-frequency rTMS. Also anatomical neuronavigation might
      increase the efficacy of rTMS due to exact targeting of the primary auditory cortex. Thus,
      the aim of this study is the evaluation of the clinical efficacy of neuronavigated left-sided
      cTBS in chronic tinnitus in a randomised sham-controlled two-arm design.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in tinnitus questionnaire total score (contrast baseline (-day 3) versus end of treatment (day 10))
time frame: -day 3; day 10
measure: Change of tinnitus questionaire total score (all baseline (-week 2, - week1, - day 3) vs. all follow-up visits (day 6, day 10, week 1, week 3, week 8))
time frame: -week 2; - week1; - day 3; day 6; day 10; week 1; week 3; week 8
measure: Change of tinnitus handicap inventory total score (all baseline (-week 2, - week1, - day 3) vs. all follow-up visits (day 6, day 10, week 1, week 3, week 8))
time frame: -week 2; - week1; - day 3; day 6; day 10; week 1; week 3; week 8
measure: Change of tinnitus numeric rating scales (all baseline (-week 2, - week1, - day 3) vs. all follow-up visits (day 6, day 10, week 1, week 3, week 8))
time frame: -week 2; - week1; - day 3; day 6; day 10; week 1; week 3; week 8
measure: Change of depressive symptoms as measured by the Beck Depression Inventory II (BDI) (baseline visit -week 2 vs. all follow-up visits (day 6, day 10, week 1, week 3, week 8))
time frame: -week 2; day 6; day 10; week 1; week 3; week 8
arm group label: Left temporal verum cTBS
arm group type: Experimental
description: Continuous theta burst stimulation (MC-B70, MagPro,MagOption, Medtronic, Germany): 400 triplets of stimuli (triplets with 50Hz) at an frequency of 5Hz (in sum 1200 stimuli) with a break after 200 bursts over the left Heschl's gyrus targeted with anatomical neuronavigation (Localite, Germany); 30% maximum stimulator output (each session)
Intervention: Left temporal verum cTBS
arm group label: Left temporal placebo cTBS
arm group type: Experimental
description: Continuous theta burst stimulation (MC-B70, MagPro,MagOption, Medtronic, Germany): 400 triplets of stimuli (triplets with 50Hz) at an frequency of 5Hz (in sum 1200 stimuli) with a break after 200 bursts over the left Heschl's gyrus targeted with anatomical neuronavigation (Localite, Germany); 30% maximum stimulator output (each session); coil tilted by 45° over both wings
Intervention: Left temporal placebo cTBS
intervention type: Device
intervention name: Left temporal verum cTBS
description: Continuous theta burst stimulation (MC-B70, MagPro,MagOption, Medtronic, Germany): 400 triplets of stimuli (triplets with 50Hz) at an frequency of 5Hz (in sum 1200 stimuli) with a break after 200 bursts over the left Heschl's gyrus targeted with anatomical neuronavigation (Localite, Germany); 30% maximum stimulator output (each session)
Arms: Left temporal verum cTBS
arm group label: Left temporal verum cTBS
other name: MC-B70, MagPro,MagOption, Medtronic, Germany
intervention type: Device
intervention name: Left temporal placebo cTBS
description: Continuous theta burst stimulation (MC-B70, MagPro,MagOption, Medtronic, Germany): 400 triplets of stimuli (triplets with 50Hz) at an frequency of 5Hz (in sum 1200 stimuli) with a break after 200 bursts over the left Heschl's gyrus targeted with anatomical neuronavigation (Localite, Germany); 30% maximum stimulator output (each session); coil tilted by 45° over both wings
Arms: Left temporal placebo cTBS
arm group label: Left temporal placebo cTBS
other name: MC-B70, MagPro,MagOption, Medtronic, Germany
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Berthold Langguth
role: Principal Investigator
affiliation: University of Regensburg
facility: 
facility: 
facility: 
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University of Regensburg
investigator full name: Berthold Langguth, MD, Ph.D.
investigator title: MD, PhD
mesh term: Tinnitus