<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/NCT01663311</url>
  </required_header>
  <id_info>
    <org_study_id>Uni-Reg-Ti-CDC01</org_study_id>
    <nct_id>NCT01663311</nct_id>
  </id_info>
  <brief_title>Repetitive Transcranial Magnetic Stimulation With Double Cone Coil in Chronic Tinnitus</brief_title>
  <acronym>Ti-CDC</acronym>
  <official_title>Effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) With Double-Cone-Coil in Patients With Chronic Tinnitus (Ti-CDC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Regensburg</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Regensburg</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Transcranial Magnetic Stimulation is used to modulate both the auditory neural pathways&#xD;
      contributing to the perception of phantom sounds, and the regulatory neural network&#xD;
      responsible for the generation of the individual amount of suffering caused by chronic&#xD;
      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. Treatment remains difficult. Most available therapies&#xD;
      focus on habituation rather than treating the cause. Tinnitus has been shown to be generated&#xD;
      in the brain, as a result of functional reorganization of auditory neural pathways and&#xD;
      tonotopic maps in the central auditory system. Low-frequency rTMS applied to the&#xD;
      temporoparietal areas has been investigated for the treatment of hyperexcitability disorders&#xD;
      such as auditory hallucinations and tinnitus. Pilot data indicate that taking into account&#xD;
      affective components of the multiple overlapping neural networks responsible for the&#xD;
      generation of a bothersome subjective tinnitus might enhance the efficacy of Repetitive&#xD;
      Transcranial Magnetic Stimulation (rTMS) treatment in chronic tinnitus. A newly developed&#xD;
      coil, the so-called double cone coil will be examined with regard to feasibility, safety and&#xD;
      clinical efficacy in patients suffering from chronic tinnitus in a controlled pilot trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of treatment responders (TQ reduction &gt; 5, contrast Baseline versus end of treatment/ day 12)</measure>
    <time_frame>Day 12</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&amp;Hiller, Tinnitus Handicap Inventory (THI), Tinnitus Severity Scale and TBF-12</measure>
    <time_frame>Baseline vs. day 90</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of depressive symptoms as measured by the Major Depression Inventory (MDI)</measure>
    <time_frame>Baseline vs. day 90</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life as measured by the WHOQoL</measure>
    <time_frame>Baseline vs. day 90</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Chronic Tinnitus</condition>
  <arm_group>
    <arm_group_label>Medial Frontal rTMS Double-Cone-Coil</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>High frequency rTMS ( Alpine Biomed Mag Pro Option) applied over medial superior frontal cortex (supplementary motor cortex) (Brodman area 6/8),Double-Cone-water-cooled-Coil (2000 Stimuli of 10 Hz each session), 110% motor threshold; followed by: low frequency rTMS ( Alpine Biomed Mag Pro Option) applied over left temporoparietal cortex, Butterfly-water-cooled-Coil (2000 Stimuli of 1 Hz each session), 110% motor threshold.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Left DLPFC Butterfly Coil</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>High frequency rTMS ( Alpine Biomed Mag Pro Option): 2000 stimuli of 20 Hz over the left DLPFC (each session), Butterfly-water-cooled-Coil, 110% motor threshold; followed by: low frequency rTMS ( Alpine Biomed Mag Pro Option) applied over left temporoparietal cortex, Butterfly-water-cooled-Coil (2000 Stimuli of 1 Hz each session), 110% motor threshold.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Medial Frontal rTMS Double-Cone-Coil</intervention_name>
    <description>High frequency rTMS ( Alpine Biomed Mag Pro Option) applied over medial superior frontal cortex (supplementary motor cortex) (Brodman area 6/8),Double-Cone-water-cooled-Coil (2000 Stimuli of 10 Hz each session), 110% motor threshold; followed by: low frequency rTMS ( Alpine Biomed Mag Pro Option) applied over left temporoparietal cortex, Butterfly-water-cooled-Coil (2000 Stimuli of 1 Hz each session), 110% motor threshold.</description>
    <arm_group_label>Medial Frontal rTMS Double-Cone-Coil</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Left DLPFC Butterfly Coil</intervention_name>
    <description>High frequency rTMS ( Alpine Biomed Mag Pro Option): 2000 stimuli of 20 Hz over the left DLPFC (each session), Butterfly-water-cooled-Coil, 110% motor threshold; followed by: low frequency rTMS ( Alpine Biomed Mag Pro Option) applied over left temporoparietal cortex, Butterfly-water-cooled-Coil (2000 Stimuli of 1 Hz each session), 110% motor threshold.</description>
    <arm_group_label>Left DLPFC Butterfly Coil</arm_group_label>
  </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;
          -  Prior treatment with TMS&#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, MD, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Regensburg, Dept of Psychiatry</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Regensburg- Dept of Psychiatry</name>
      <address>
        <city>Regensburg</city>
        <zip>93053</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>April 2014</verification_date>
  <study_first_submitted>July 23, 2012</study_first_submitted>
  <study_first_submitted_qc>August 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2012</study_first_posted>
  <last_update_submitted>April 25, 2014</last_update_submitted>
  <last_update_submitted_qc>April 25, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 28, 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, Ph.D.</investigator_title>
  </responsible_party>
  <keyword>rTMS</keyword>
  <keyword>repetitive transcranial magnetic stimulation</keyword>
  <keyword>chronic tinnitus</keyword>
  <keyword>subjective tinnitus</keyword>
  <keyword>double cone coil</keyword>
  <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/NCT01663311
org study id: Uni-Reg-Ti-CDC01
nct id: NCT01663311
lead sponsor: 
has dmc: No
Transcranial Magnetic Stimulation is used to modulate both the auditory neural pathways
      contributing to the perception of phantom sounds, and the regulatory neural network
      responsible for the generation of the individual amount of suffering caused by 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. Treatment remains difficult. Most available therapies
      focus on habituation rather than treating the cause. Tinnitus has been shown to be generated
      in the brain, as a result of functional reorganization of auditory neural pathways and
      tonotopic maps in the central auditory system. Low-frequency rTMS applied to the
      temporoparietal areas has been investigated for the treatment of hyperexcitability disorders
      such as auditory hallucinations and tinnitus. Pilot data indicate that taking into account
      affective components of the multiple overlapping neural networks responsible for the
      generation of a bothersome subjective tinnitus might enhance the efficacy of Repetitive
      Transcranial Magnetic Stimulation (rTMS) treatment in chronic tinnitus. A newly developed
      coil, the so-called double cone coil will be examined with regard to feasibility, safety and
      clinical efficacy in patients suffering from chronic tinnitus in a controlled pilot trial.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Number of treatment responders (TQ reduction > 5, contrast Baseline versus end of treatment/ day 12)
time frame: Day 12
measure: Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller, Tinnitus Handicap Inventory (THI), Tinnitus Severity Scale and TBF-12
time frame: Baseline vs. day 90
measure: Change of depressive symptoms as measured by the Major Depression Inventory (MDI)
time frame: Baseline vs. day 90
measure: Change in quality of life as measured by the WHOQoL
time frame: Baseline vs. day 90
arm group label: Medial Frontal rTMS Double-Cone-Coil
arm group type: Experimental
description: High frequency rTMS ( Alpine Biomed Mag Pro Option) applied over medial superior frontal cortex (supplementary motor cortex) (Brodman area 6/8),Double-Cone-water-cooled-Coil (2000 Stimuli of 10 Hz each session), 110% motor threshold; followed by: low frequency rTMS ( Alpine Biomed Mag Pro Option) applied over left temporoparietal cortex, Butterfly-water-cooled-Coil (2000 Stimuli of 1 Hz each session), 110% motor threshold.
arm group label: Left DLPFC Butterfly Coil
arm group type: Experimental
description: High frequency rTMS ( Alpine Biomed Mag Pro Option): 2000 stimuli of 20 Hz over the left DLPFC (each session), Butterfly-water-cooled-Coil, 110% motor threshold; followed by: low frequency rTMS ( Alpine Biomed Mag Pro Option) applied over left temporoparietal cortex, Butterfly-water-cooled-Coil (2000 Stimuli of 1 Hz each session), 110% motor threshold.
intervention type: Device
intervention name: Medial Frontal rTMS Double-Cone-Coil
description: High frequency rTMS ( Alpine Biomed Mag Pro Option) applied over medial superior frontal cortex (supplementary motor cortex) (Brodman area 6/8),Double-Cone-water-cooled-Coil (2000 Stimuli of 10 Hz each session), 110% motor threshold; followed by: low frequency rTMS ( Alpine Biomed Mag Pro Option) applied over left temporoparietal cortex, Butterfly-water-cooled-Coil (2000 Stimuli of 1 Hz each session), 110% motor threshold.
arm group label: Medial Frontal rTMS Double-Cone-Coil
intervention type: Device
intervention name: Left DLPFC Butterfly Coil
description: High frequency rTMS ( Alpine Biomed Mag Pro Option): 2000 stimuli of 20 Hz over the left DLPFC (each session), Butterfly-water-cooled-Coil, 110% motor threshold; followed by: low frequency rTMS ( Alpine Biomed Mag Pro Option) applied over left temporoparietal cortex, Butterfly-water-cooled-Coil (2000 Stimuli of 1 Hz each session), 110% motor threshold.
arm group label: Left DLPFC Butterfly Coil
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Berthold Langguth, MD, Ph.D.
role: Principal Investigator
affiliation: University of Regensburg, Dept of Psychiatry
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University of Regensburg
investigator full name: Berthold Langguth, MD, Ph.D.
investigator title: MD, Ph.D.
mesh term: Tinnitus