<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/NCT03759834</url>
  </required_header>
  <id_info>
    <org_study_id>17-004832</org_study_id>
    <nct_id>NCT03759834</nct_id>
  </id_info>
  <brief_title>Cochlear Promontory Stimulation for Treatment of Tinnitus</brief_title>
  <official_title>Cochlear Promontory Stimulation for Treatment of Tinnitus: Towards Developing an Implantable Device</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Tinnitus is the perception of sound when no external noise is present. The Center for Disease&#xD;
      Control (CDC) estimates over 50 million - nearly 15% of the general public -experience some&#xD;
      form of tinnitus. Roughly 20 million people struggle with burdensome chronic tinnitus, with 2&#xD;
      million experiencing extreme and debilitating symptoms.&#xD;
&#xD;
      The 2014 Clinical Practice Guideline on tinnitus from the American Academy of Otolaryngology&#xD;
      - Head and Neck Surgery summarized the existing state of tinnitus management by stating &quot;A&#xD;
      cure for primary tinnitus does not yet exist, and despite claims to the contrary, no method&#xD;
      has been proven to provide long-term suppression of tinnitus.&quot;&#xD;
&#xD;
      The purpose of this study is to look at the safety and efficacy of cochlear promontory&#xD;
      stimulation in the short term relief of tinnitus. The secondary goal of the study is to&#xD;
      determine the optimum region(s) of the cochlear promontory in planning for an implantable&#xD;
      electrical device for long term tinnitus suppression.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Candidate subjects will undergo a temporal bone Computed Tomography (CT) scan, contrast&#xD;
      enhanced head Magnetic Resonance Imaging (MRI), audiogram with immittance testing, pitch and&#xD;
      level matching of tinnitus, Distortion Product Otoacoustic Emissions (DPOAE) and Auditory&#xD;
      Brainstem Response (ABR) testing prior to promontory stimulation. Head MRI, DPOAE, audiogram&#xD;
      and immittance testing are considered clinically routine for assessment of asymmetric&#xD;
      tinnitus. Temporal bone CT, ABR, tinnitus pitch, level matching, masking levels and residual&#xD;
      inhibition testing are not standard clinical assessments for asymmetric tinnitus. In&#xD;
      addition, subjects will complete the Tinnitus Handicap Inventory (THI), Tinnitus Functional&#xD;
      Index (TFI) and Visual Analog Scale (VAS) questionnaires three separate times within the week&#xD;
      prior to promontory stimulation testing. Additional testing for comorbid anxiety and&#xD;
      depressive conditions will be a screening Generalized Anxiety Disorder (GAD7), Patient Health&#xD;
      Questionnaire (PHQ8), and short Health Anxiety Inventory (HAI-S). The NEO Personality&#xD;
      Inventory (NEO PI) will be administered to provide baseline information. The initial session&#xD;
      of promontory stimulation will define optimal stimulation parameters (i.e., location, current&#xD;
      level, pulse-width, phase polarity), where maximal tinnitus suppression occurs with minimal&#xD;
      or no auditory percept. After these parameters are established, the patient will complete the&#xD;
      THI, TFI, and VAS immediately prior to stimulation, during stimulation, and following&#xD;
      completion of stimulation at 10-minutes, 1-hour, 24-hours, 48-hours, and 1-week following&#xD;
      completion of stimulation. In addition, pitch and level matching of tinnitus will be&#xD;
      completed immediately upon completion of each promontory stimulation session. Each patient&#xD;
      will undergo three successive treatments separated by 1-week. Prior to each treatment, the&#xD;
      patient will receive an audiogram and DPOAE testing to document interval safety. At the&#xD;
      conclusion of the study, subjects will be asked about their willingness to undergo surgical&#xD;
      implantation of a device capable of long-term scheduled or on-demand electrical stimulation&#xD;
      for tinnitus suppression&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    Enrollment for study is currently on hold pending additional funding and resources.&#xD;
  </why_stopped>
  <start_date type="Actual">January 4, 2018</start_date>
  <completion_date type="Anticipated">June 2024</completion_date>
  <primary_completion_date type="Anticipated">June 2024</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>
    <masking_description>The electrode will be placed in the middle ear. The patient and investigator will be blinded to the &quot;on-off&quot; status of the device. The patient will report if they have improvement of their tinnitus while both the patient and investigator are blinded to the &quot;on-off&quot; status.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Short Term Relief of Tinnitus as Measured by the Tinnitus Handicap Inventory</measure>
    <time_frame>7 days after electrical stimulation procedure</time_frame>
    <description>The Tinnitus Handicap Inventory (THI) has 25 questions with possible answers of Yes (4 points), Sometimes (2 points), and No (0 points). Scores categories are (1-16: Slight or no handicap - Grade 1), (18-36: Mild handicap - Grade 2), (38-56: Moderate handicap - Grade 3), (58-76: Severe handicap - Grade 4), (78-100: Catastrophic handicap - Grade 5).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Optimal Location of Tinnitus Relief</measure>
    <time_frame>Immediately after electrical stimulation procedure (approximately 1 min after stimulation)</time_frame>
    <description>Location on the cochlear promontory where highest perceived benefit from electrical stimulation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Auditory Feedback</measure>
    <time_frame>Immediately after electrical stimulation procedure (approximately 1 min after stimulation)</time_frame>
    <description>Perception of hearing the electrical stimulus (if at all)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tactile Feedback</measure>
    <time_frame>Immediately after electrical stimulation procedure (approximately 1 min after stimulation)</time_frame>
    <description>Perception of hearing the electrical stimulus (if at all)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short Term Relief of Tinnitus as Measured by the Tinnitus Functional Index</measure>
    <time_frame>7 days after electrical stimulation procedure</time_frame>
    <description>The Tinnitus Functional Index (TFI) contains eight subscales (domains), of which seven contain 3 items and one contains 4. The possible responses for each item range from 0 (did not interfere) to 10 (completely interfered). The total score is transformed to a scale ranging from 0 (no interference) to 100 (completely interfered with activities).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short Term Relief of Tinnitus as Measured by the Visual Analog Scale</measure>
    <time_frame>7 days after electrical stimulation procedure</time_frame>
    <description>The Visual Analog Scale (VAS) for Numeric Pain Distress was used for this outcome. The VAS has pre-set marks between the extremes of 0 (no pain) and 10 (unbearable pain).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Tinnitus</condition>
  <arm_group>
    <arm_group_label>Testing Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>There will only be one arm. The patient and investigator will initially be blinded to the &quot;on-off&quot; status of the electrode. The patient will thus serve as an internal control for testing. Once device integrity and possible benefit is confirmed, the patients will undergo non-tactile electrical stimulation to the bone of the inner ear (cochlear promontory) for short term relief of tinnitus via Cochlear promontory stimulation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cochlear promontory stimulation</intervention_name>
    <description>Promontory stimulation is an established otologic procedure that was initially developed as a diagnostic tool to assess patient candidacy for cochlear implantation. Promontory stimulation is most commonly performed in the outpatient setting on an awake patient by placing a single insulated probe through a topically anesthetized tympanic membrane and applying monopolar current for several seconds to minutes. The initial session of promontory stimulation will define optimal stimulation parameters (i.e., location, current level, pulse-width, phase polarity), where maximal tinnitus suppression occurs with minimal or no auditory percept. Additional stimulation testing visits will confirm these findings.</description>
    <arm_group_label>Testing Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Normal to moderate sensorineural hearing loss (based on pure tone audiometry (PTA) of&#xD;
             500, 1000 and 2000 Hz) and a word recognition score greater than 75%&#xD;
&#xD;
          2. Asymmetric subjective tonal tinnitus&#xD;
&#xD;
          3. Tinnitus that is disruptive&#xD;
&#xD;
               1. Determined by THI score (in the severe range i.e. &gt;56/100)&#xD;
&#xD;
               2. TFI (in the severe range i.e. &gt;52/100)&#xD;
&#xD;
               3. VAS (&gt; 5/10 )&#xD;
&#xD;
          4. Tinnitus that is intractable, and has not been ameliorated by conventional measures&#xD;
             such as a hearing aid or masking&#xD;
&#xD;
          5. Normal contrast-enhanced MRI of the head&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Tinnitus present less than 6 months or longer than 3 years&#xD;
&#xD;
          2. History of brain or major ear surgery&#xD;
&#xD;
          3. Prior major head trauma&#xD;
&#xD;
          4. History of depression or anxiety&#xD;
&#xD;
               1. Determined by screening using the GAD 7, PHQ8, and HAI-S&#xD;
&#xD;
                    -  GAD7 &gt; 9 (indicates clinically significant anxiety)&#xD;
&#xD;
                    -  PHQ &gt; 9 (indicates clinically significant depression)&#xD;
&#xD;
                    -  HAI-S &gt; 25 (hypochondriacal level illness anxiety)&#xD;
&#xD;
               2. Inability to assess, continue or complete trial&#xD;
&#xD;
          5. Currently on antidepressants, anxiolytics or antipsychotics&#xD;
&#xD;
          6. Active use of other tinnitus treatments&#xD;
&#xD;
          7. MRI Incompatible Devices&#xD;
&#xD;
          8. Known pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Matthew L Carlson</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <reference>
    <citation>Tunkel DE, Bauer CA, Sun GH, Rosenfeld RM, Chandrasekhar SS, Cunningham ER Jr, Archer SM, Blakley BW, Carter JM, Granieri EC, Henry JA, Hollingsworth D, Khan FA, Mitchell S, Monfared A, Newman CW, Omole FS, Phillips CD, Robinson SK, Taw MB, Tyler RS, Waguespack R, Whamond EJ. Clinical practice guideline: tinnitus. Otolaryngol Head Neck Surg. 2014 Oct;151(2 Suppl):S1-S40. doi: 10.1177/0194599814545325.</citation>
    <PMID>25273878</PMID>
  </reference>
  <reference>
    <citation>Tsai BS, Sweetow RW, Cheung SW. Audiometric asymmetry and tinnitus laterality. Laryngoscope. 2012 May;122(5):1148-53. doi: 10.1002/lary.23242. Epub 2012 Mar 23.</citation>
    <PMID>22447577</PMID>
  </reference>
  <reference>
    <citation>Perez R, Shaul C, Vardi M, Muhanna N, Kileny PR, Sichel JY. Multiple electrostimulation treatments to the promontory for tinnitus. Otol Neurotol. 2015 Feb;36(2):366-72. doi: 10.1097/MAO.0000000000000309.</citation>
    <PMID>24691511</PMID>
  </reference>
  <reference>
    <citation>Rubinstein JT, Tyler RS, Johnson A, Brown CJ. Electrical suppression of tinnitus with high-rate pulse trains. Otol Neurotol. 2003 May;24(3):478-85. doi: 10.1097/00129492-200305000-00021.</citation>
    <PMID>12806303</PMID>
  </reference>
  <reference>
    <citation>Watanabe K, Okawara D, Baba S, Yagi T. Electrocochleographic analysis of the suppression of tinnitus by electrical promontory stimulation. Audiology. 1997 May-Jun;36(3):147-54. doi: 10.3109/00206099709071968.</citation>
    <PMID>9193732</PMID>
  </reference>
  <reference>
    <citation>Steenerson RL, Cronin GW. Treatment of tinnitus with electrical stimulation. Otolaryngol Head Neck Surg. 1999 Nov;121(5):511-3. doi: 10.1016/S0194-5998(99)70048-3.</citation>
    <PMID>10547461</PMID>
  </reference>
  <reference>
    <citation>Mertens G, De Bodt M, Van de Heyning P. Cochlear implantation as a long-term treatment for ipsilateral incapacitating tinnitus in subjects with unilateral hearing loss up to 10 years. Hear Res. 2016 Jan;331:1-6. doi: 10.1016/j.heares.2015.09.016. Epub 2015 Oct 24.</citation>
    <PMID>26433053</PMID>
  </reference>
  <reference>
    <citation>Tyler RS. Patient preferences and willingness to pay for tinnitus treatments. J Am Acad Audiol. 2012 Feb;23(2):115-25. doi: 10.3766/jaaa.23.2.6.</citation>
    <PMID>22353680</PMID>
  </reference>
  <reference>
    <citation>Arts RA, George EL, Stokroos RJ, Vermeire K. Review: cochlear implants as a treatment of tinnitus in single-sided deafness. Curr Opin Otolaryngol Head Neck Surg. 2012 Oct;20(5):398-403. doi: 10.1097/MOO.0b013e3283577b66.</citation>
    <PMID>22931903</PMID>
  </reference>
  <reference>
    <citation>Arts RA, George EL, Chenault MN, Stokroos RJ. Optimizing intracochlear electrical stimulation to suppress tinnitus. Ear Hear. 2015 Jan;36(1):125-35. doi: 10.1097/AUD.0000000000000090.</citation>
    <PMID>25090456</PMID>
  </reference>
  <reference>
    <citation>Zeman F, Koller M, Figueiredo R, Aazevedo A, Rates M, Coelho C, Kleinjung T, de Ridder D, Langguth B, Landgrebe M. Tinnitus handicap inventory for evaluating treatment effects: which changes are clinically relevant? Otolaryngol Head Neck Surg. 2011 Aug;145(2):282-7. doi: 10.1177/0194599811403882.</citation>
    <PMID>21493265</PMID>
  </reference>
  <reference>
    <citation>Topf MC, Hsu DW, Adams DR, Zhan T, Pelosi S, Willcox TO, McGettigan B, Fisher KW. Rate of tympanic membrane perforation after intratympanic steroid injection. Am J Otolaryngol. 2017 Jan-Feb;38(1):21-25. doi: 10.1016/j.amjoto.2016.09.004. Epub 2016 Sep 28.</citation>
    <PMID>27751619</PMID>
  </reference>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>November 30, 2017</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>July 12, 2023</last_update_submitted>
  <last_update_submitted_qc>July 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Matthew L. Carlson, M.D.</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tinnitus</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 21, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/34/NCT03759834/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03759834
org study id: 17-004832
nct id: NCT03759834
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
Tinnitus is the perception of sound when no external noise is present. The Center for Disease
      Control (CDC) estimates over 50 million - nearly 15% of the general public -experience some
      form of tinnitus. Roughly 20 million people struggle with burdensome chronic tinnitus, with 2
      million experiencing extreme and debilitating symptoms.

      The 2014 Clinical Practice Guideline on tinnitus from the American Academy of Otolaryngology
      - Head and Neck Surgery summarized the existing state of tinnitus management by stating "A
      cure for primary tinnitus does not yet exist, and despite claims to the contrary, no method
      has been proven to provide long-term suppression of tinnitus."

      The purpose of this study is to look at the safety and efficacy of cochlear promontory
      stimulation in the short term relief of tinnitus. The secondary goal of the study is to
      determine the optimum region(s) of the cochlear promontory in planning for an implantable
      electrical device for long term tinnitus suppression.
Candidate subjects will undergo a temporal bone Computed Tomography (CT) scan, contrast
      enhanced head Magnetic Resonance Imaging (MRI), audiogram with immittance testing, pitch and
      level matching of tinnitus, Distortion Product Otoacoustic Emissions (DPOAE) and Auditory
      Brainstem Response (ABR) testing prior to promontory stimulation. Head MRI, DPOAE, audiogram
      and immittance testing are considered clinically routine for assessment of asymmetric
      tinnitus. Temporal bone CT, ABR, tinnitus pitch, level matching, masking levels and residual
      inhibition testing are not standard clinical assessments for asymmetric tinnitus. In
      addition, subjects will complete the Tinnitus Handicap Inventory (THI), Tinnitus Functional
      Index (TFI) and Visual Analog Scale (VAS) questionnaires three separate times within the week
      prior to promontory stimulation testing. Additional testing for comorbid anxiety and
      depressive conditions will be a screening Generalized Anxiety Disorder (GAD7), Patient Health
      Questionnaire (PHQ8), and short Health Anxiety Inventory (HAI-S). The NEO Personality
      Inventory (NEO PI) will be administered to provide baseline information. The initial session
      of promontory stimulation will define optimal stimulation parameters (i.e., location, current
      level, pulse-width, phase polarity), where maximal tinnitus suppression occurs with minimal
      or no auditory percept. After these parameters are established, the patient will complete the
      THI, TFI, and VAS immediately prior to stimulation, during stimulation, and following
      completion of stimulation at 10-minutes, 1-hour, 24-hours, 48-hours, and 1-week following
      completion of stimulation. In addition, pitch and level matching of tinnitus will be
      completed immediately upon completion of each promontory stimulation session. Each patient
      will undergo three successive treatments separated by 1-week. Prior to each treatment, the
      patient will receive an audiogram and DPOAE testing to document interval safety. At the
      conclusion of the study, subjects will be asked about their willingness to undergo surgical
      implantation of a device capable of long-term scheduled or on-demand electrical stimulation
      for tinnitus suppression
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
masking description: The electrode will be placed in the middle ear. The patient and investigator will be blinded to the "on-off" status of the device. The patient will report if they have improvement of their tinnitus while both the patient and investigator are blinded to the "on-off" status.
measure: Short Term Relief of Tinnitus as Measured by the Tinnitus Handicap Inventory
time frame: 7 days after electrical stimulation procedure
description: The Tinnitus Handicap Inventory (THI) has 25 questions with possible answers of Yes (4 points), Sometimes (2 points), and No (0 points). Scores categories are (1-16: Slight or no handicap - Grade 1), (18-36: Mild handicap - Grade 2), (38-56: Moderate handicap - Grade 3), (58-76: Severe handicap - Grade 4), (78-100: Catastrophic handicap - Grade 5).
measure: Optimal Location of Tinnitus Relief
time frame: Immediately after electrical stimulation procedure (approximately 1 min after stimulation)
description: Location on the cochlear promontory where highest perceived benefit from electrical stimulation
measure: Auditory Feedback
time frame: Immediately after electrical stimulation procedure (approximately 1 min after stimulation)
description: Perception of hearing the electrical stimulus (if at all)
measure: Tactile Feedback
time frame: Immediately after electrical stimulation procedure (approximately 1 min after stimulation)
description: Perception of hearing the electrical stimulus (if at all)
measure: Short Term Relief of Tinnitus as Measured by the Tinnitus Functional Index
time frame: 7 days after electrical stimulation procedure
description: The Tinnitus Functional Index (TFI) contains eight subscales (domains), of which seven contain 3 items and one contains 4. The possible responses for each item range from 0 (did not interfere) to 10 (completely interfered). The total score is transformed to a scale ranging from 0 (no interference) to 100 (completely interfered with activities).
measure: Short Term Relief of Tinnitus as Measured by the Visual Analog Scale
time frame: 7 days after electrical stimulation procedure
description: The Visual Analog Scale (VAS) for Numeric Pain Distress was used for this outcome. The VAS has pre-set marks between the extremes of 0 (no pain) and 10 (unbearable pain).
arm group label: Testing Arm
arm group type: Experimental
description: There will only be one arm. The patient and investigator will initially be blinded to the "on-off" status of the electrode. The patient will thus serve as an internal control for testing. Once device integrity and possible benefit is confirmed, the patients will undergo non-tactile electrical stimulation to the bone of the inner ear (cochlear promontory) for short term relief of tinnitus via Cochlear promontory stimulation.
intervention type: Device
intervention name: Cochlear promontory stimulation
description: Promontory stimulation is an established otologic procedure that was initially developed as a diagnostic tool to assess patient candidacy for cochlear implantation. Promontory stimulation is most commonly performed in the outpatient setting on an awake patient by placing a single insulated probe through a topically anesthetized tympanic membrane and applying monopolar current for several seconds to minutes. The initial session of promontory stimulation will define optimal stimulation parameters (i.e., location, current level, pulse-width, phase polarity), where maximal tinnitus suppression occurs with minimal or no auditory percept. Additional stimulation testing visits will confirm these findings.
arm group label: Testing Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Matthew L Carlson
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
citation: Tunkel DE, Bauer CA, Sun GH, Rosenfeld RM, Chandrasekhar SS, Cunningham ER Jr, Archer SM, Blakley BW, Carter JM, Granieri EC, Henry JA, Hollingsworth D, Khan FA, Mitchell S, Monfared A, Newman CW, Omole FS, Phillips CD, Robinson SK, Taw MB, Tyler RS, Waguespack R, Whamond EJ. Clinical practice guideline: tinnitus. Otolaryngol Head Neck Surg. 2014 Oct;151(2 Suppl):S1-S40. doi: 10.1177/0194599814545325.
PMID: 25273878
citation: Tsai BS, Sweetow RW, Cheung SW. Audiometric asymmetry and tinnitus laterality. Laryngoscope. 2012 May;122(5):1148-53. doi: 10.1002/lary.23242. Epub 2012 Mar 23.
PMID: 22447577
citation: Perez R, Shaul C, Vardi M, Muhanna N, Kileny PR, Sichel JY. Multiple electrostimulation treatments to the promontory for tinnitus. Otol Neurotol. 2015 Feb;36(2):366-72. doi: 10.1097/MAO.0000000000000309.
PMID: 24691511
citation: Rubinstein JT, Tyler RS, Johnson A, Brown CJ. Electrical suppression of tinnitus with high-rate pulse trains. Otol Neurotol. 2003 May;24(3):478-85. doi: 10.1097/00129492-200305000-00021.
PMID: 12806303
citation: Watanabe K, Okawara D, Baba S, Yagi T. Electrocochleographic analysis of the suppression of tinnitus by electrical promontory stimulation. Audiology. 1997 May-Jun;36(3):147-54. doi: 10.3109/00206099709071968.
PMID: 9193732
citation: Steenerson RL, Cronin GW. Treatment of tinnitus with electrical stimulation. Otolaryngol Head Neck Surg. 1999 Nov;121(5):511-3. doi: 10.1016/S0194-5998(99)70048-3.
PMID: 10547461
citation: Mertens G, De Bodt M, Van de Heyning P. Cochlear implantation as a long-term treatment for ipsilateral incapacitating tinnitus in subjects with unilateral hearing loss up to 10 years. Hear Res. 2016 Jan;331:1-6. doi: 10.1016/j.heares.2015.09.016. Epub 2015 Oct 24.
PMID: 26433053
citation: Tyler RS. Patient preferences and willingness to pay for tinnitus treatments. J Am Acad Audiol. 2012 Feb;23(2):115-25. doi: 10.3766/jaaa.23.2.6.
PMID: 22353680
citation: Arts RA, George EL, Stokroos RJ, Vermeire K. Review: cochlear implants as a treatment of tinnitus in single-sided deafness. Curr Opin Otolaryngol Head Neck Surg. 2012 Oct;20(5):398-403. doi: 10.1097/MOO.0b013e3283577b66.
PMID: 22931903
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responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Matthew L. Carlson, M.D.
investigator title: Principal Investigator
mesh term: Tinnitus
provided document: 