<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/NCT04404439</url>
  </required_header>
  <id_info>
    <org_study_id>HS# 2018-4458</org_study_id>
    <nct_id>NCT04404439</nct_id>
  </id_info>
  <brief_title>Treatment of Tinnitus With Migraine Medications</brief_title>
  <official_title>Treatment of Tinnitus With Migraine Medications: A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Irvine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Irvine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Tinnitus represents one of the most common and distressing otologic problems, and it causes&#xD;
      various somatic and psychological disorders that interfere with the quality of life. It is&#xD;
      well-understood that many factors, such as poor education, lower income, or occupational, and&#xD;
      recreational activity associated with high noise exposure, influences the prevalence and risk&#xD;
      of tinnitus. Although the economic and emotional impact of tinnitus is large, there is&#xD;
      currently no FDA-approved medication to treat this condition. However, there are&#xD;
      pharmacological options to address the stress, anxiety, and depression that are caused by&#xD;
      tinnitus. In this project, we intend to use medications for patients with tinnitus in order&#xD;
      to decrease the impact of tinnitus on their daily life and activities.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is 8 weeks in duration. There are three arms in the experiment: the first is&#xD;
      nortriptyline (7.5 mg) plus topiramate (10 mg), the second is verapamil (30 mg) plus&#xD;
      paroxetine (4 mg), and the third is a placebo group. This is a double-blinded trial.&#xD;
      Participants will be randomized to one arm for the duration of the trial using simple&#xD;
      randomization with a computer-generated number. Both medication combinations and placebo may&#xD;
      include dosage increases weekly if symptoms do not improve. Nortriptyline may be increased by&#xD;
      7.5mg weekly (to a maximum of 60mg), topiramate by 10mg weekly (maximum 80mg), verapamil by&#xD;
      30mg weekly (maximum 240mg), and paroxetine by 4mg weekly (maximum 32mg). Symptomatic survey&#xD;
      scores from each arm will be obtained before and after treatment and weekly. An unblinded&#xD;
      neurotologist attending (Dr. Harrison Lin) will also become involved with patients'&#xD;
      treatments as they start to report changes in symptoms in order to monitor their safety and&#xD;
      provide advice on change in dosage if patients have questions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 26, 2019</start_date>
  <completion_date type="Anticipated">December 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2023</primary_completion_date>
  <phase>Phase 4</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>
    <intervention_model_description>Participants will be assigned to a study group by chance (like a coin flip) rather than by a medical decision made by the researchers. There are three arms in the study (treatment group 1 which consists of nortriptyline + topiramate, treatment group 2 which consist of verapamil + paroxetine, and a placebo group), and participants enrolling in the trial will be randomly assigned in a 1:1:1 fashion to one of the arms. The participant will remain in the same arm for the duration of the study (8 weeks). There may be multiple participants in each arm who are undergoing the study at the same time (parallel model).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Tinnitus Functional Index (TFI)</measure>
    <time_frame>8 weeks</time_frame>
    <description>Subjective improvement from baseline in tinnitus symptoms as measured by Tinnitus Functional Index (TFI). The TFI is scored from 0% to 100%, with higher scores indicating a more negative impact of tinnitus.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual Analog Scale (VAS)</measure>
    <time_frame>8 weeks</time_frame>
    <description>Subjective improvement in tinnitus loudness severity based on a visual analog scale (VAS). The VAS is scored from 0 to 10, with a higher score representing an increased severity of tinnitus.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Health Questionnaire (PHQ)</measure>
    <time_frame>8 weeks</time_frame>
    <description>Subjective improvement in depression symptoms based on patient health questionnaire (PHQ). The PHQ is scored from 0 to 27, with a higher score indicating increased depression severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived Stress Scale (PSS)</measure>
    <time_frame>8 weeks</time_frame>
    <description>Subjective improvement in stress based on perceived stress scale (PSS). The PSS is scored from 0 to 40, with higher scores indicating higher perceived stress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep Quality Index (SQI)</measure>
    <time_frame>8 weeks</time_frame>
    <description>Subjective improvement in sleep quality based on sleep quality index (SQI). The SQI is scored from 0 to 21, with higher scores indicating worse quality of sleep.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Tinnitus, Subjective</condition>
  <condition>Tinnitus</condition>
  <arm_group>
    <arm_group_label>Nortriptyline + topiramate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nortriptyline (7.5 mg) plus topiramate (10 mg) in a single pill initially taken once daily. Dose may be increased as directed by care provider by 7.5mg weekly (to a maximum of 60mg) for nortriptyline, and by 10mg weekly (maximum 80mg) for topiramate.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Verapamil + paroxetine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Verapamil (30 mg) plus paroxetine (4 mg) in a single pill initially taken once daily. Dose may be increased as directed by care provider by 30mg weekly (to a maximum of 240mg) for verapamil, and by 4mg weekly (maximum 32mg) for paroxetine.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo pill.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nortriptyline + topiramate</intervention_name>
    <description>Treatment group 1</description>
    <arm_group_label>Nortriptyline + topiramate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Verapamil + paroxetine</intervention_name>
    <description>Treatment group 2</description>
    <arm_group_label>Verapamil + paroxetine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo comparator</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with moderate to severe tinnitus.&#xD;
&#xD;
          -  Male or female between the ages of 25 to 85 years.&#xD;
&#xD;
          -  Subject must be compliant with the medication and attend study visits.&#xD;
&#xD;
          -  Must be able to read and write in the English language to provide consenting.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy will result in automatic exclusion from the study. Rule out of pregnancy&#xD;
             will be done by a urine pregnancy test to confirm the situation for all women who are&#xD;
             of child bearing potential.&#xD;
&#xD;
          -  Subject with history of an adverse reaction to medication being prescribed.&#xD;
&#xD;
          -  Subject suffers from a medical condition or has history that may be concerning to the&#xD;
             investigators clinical opinion.&#xD;
&#xD;
          -  All contraindications for the medications which prevent subjects from randomization&#xD;
             will be considered as exclusion criteria.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hamid R Djalilian, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Univeristy of California, Irvine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hamid R Djalilian, MD</last_name>
    <phone>800-263-9547</phone>
    <email>hdjalili@hs.uci.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of California, Irvine Medical Center ENT Clinic (Pavilion 2)</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hamid R Djalilian, MD</last_name>
      <phone>800-263-9547</phone>
      <email>hdjalili@hs.uci.edu</email>
    </contact>
    <contact_backup>
      <last_name>Mehdi Abouzari, MD, PhD</last_name>
      <phone>714-509-6096</phone>
      <email>mabouzar@hs.uci.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Hamid R Djalilian, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Mehdi Abouzari, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Evans RW, Ishiyama G. Migraine with transient unilateral hearing loss and tinnitus. Headache. 2009 May;49(5):756-8. doi: 10.1111/j.1526-4610.2008.01075.x. No abstract available.</citation>
    <PMID>19472451</PMID>
  </reference>
  <reference>
    <citation>Sindhusake D, Golding M, Newall P, Rubin G, Jakobsen K, Mitchell P. Risk factors for tinnitus in a population of older adults: the blue mountains hearing study. Ear Hear. 2003 Dec;24(6):501-7. doi: 10.1097/01.AUD.0000100204.08771.3D.</citation>
    <PMID>14663349</PMID>
  </reference>
  <reference>
    <citation>Dobie RA. A review of randomized clinical trials in tinnitus. Laryngoscope. 1999 Aug;109(8):1202-11. doi: 10.1097/00005537-199908000-00004.</citation>
    <PMID>10443820</PMID>
  </reference>
  <reference>
    <citation>Langguth B, Hund V, Busch V, Jurgens TP, Lainez JM, Landgrebe M, Schecklmann M. Tinnitus and Headache. Biomed Res Int. 2015;2015:797416. doi: 10.1155/2015/797416. Epub 2015 Oct 25.</citation>
    <PMID>26583133</PMID>
  </reference>
  <reference>
    <citation>Langguth B, Hund V, Landgrebe M, Schecklmann M. Tinnitus Patients with Comorbid Headaches: The Influence of Headache Type and Laterality on Tinnitus Characteristics. Front Neurol. 2017 Aug 28;8:440. doi: 10.3389/fneur.2017.00440. eCollection 2017.</citation>
    <PMID>28894434</PMID>
  </reference>
  <reference>
    <citation>Guichard E, Montagni I, Tzourio C, Kurth T. Association Between Headaches and Tinnitus in Young Adults: Cross-Sectional Study. Headache. 2016 Jun;56(6):987-94. doi: 10.1111/head.12845. Epub 2016 May 20.</citation>
    <PMID>27197786</PMID>
  </reference>
  <reference>
    <citation>Duckert LG, Rees TS. Treatment of tinnitus with intravenous lidocaine: a double-blind randomized trial. Otolaryngol Head Neck Surg. 1983 Oct;91(5):550-5. doi: 10.1177/019459988309100514.</citation>
    <PMID>6417606</PMID>
  </reference>
  <reference>
    <citation>Hallam RS, McKenna L, Shurlock L. Tinnitus impairs cognitive efficiency. Int J Audiol. 2004 Apr;43(4):218-26. doi: 10.1080/14992020400050030.</citation>
    <PMID>15250126</PMID>
  </reference>
  <reference>
    <citation>Muhlau M, Rauschecker JP, Oestreicher E, Gaser C, Rottinger M, Wohlschlager AM, Simon F, Etgen T, Conrad B, Sander D. Structural brain changes in tinnitus. Cereb Cortex. 2006 Sep;16(9):1283-8. doi: 10.1093/cercor/bhj070. Epub 2005 Nov 9.</citation>
    <PMID>16280464</PMID>
  </reference>
  <reference>
    <citation>Landgrebe M, Langguth B, Rosengarth K, Braun S, Koch A, Kleinjung T, May A, de Ridder D, Hajak G. Structural brain changes in tinnitus: grey matter decrease in auditory and non-auditory brain areas. Neuroimage. 2009 May 15;46(1):213-8. doi: 10.1016/j.neuroimage.2009.01.069. Epub 2009 Feb 12.</citation>
    <PMID>19413945</PMID>
  </reference>
  <reference>
    <citation>Price JL, Drevets WC. Neurocircuitry of mood disorders. Neuropsychopharmacology. 2010 Jan;35(1):192-216. doi: 10.1038/npp.2009.104.</citation>
    <PMID>19693001</PMID>
  </reference>
  <reference>
    <citation>Ploghaus A, Tracey I, Gati JS, Clare S, Menon RS, Matthews PM, Rawlins JN. Dissociating pain from its anticipation in the human brain. Science. 1999 Jun 18;284(5422):1979-81. doi: 10.1126/science.284.5422.1979.</citation>
    <PMID>10373114</PMID>
  </reference>
  <reference>
    <citation>Wager TD, Rilling JK, Smith EE, Sokolik A, Casey KL, Davidson RJ, Kosslyn SM, Rose RM, Cohen JD. Placebo-induced changes in FMRI in the anticipation and experience of pain. Science. 2004 Feb 20;303(5661):1162-7. doi: 10.1126/science.1093065.</citation>
    <PMID>14976306</PMID>
  </reference>
  <reference>
    <citation>Roberts LE, Eggermont JJ, Caspary DM, Shore SE, Melcher JR, Kaltenbach JA. Ringing ears: the neuroscience of tinnitus. J Neurosci. 2010 Nov 10;30(45):14972-9. doi: 10.1523/JNEUROSCI.4028-10.2010.</citation>
    <PMID>21068300</PMID>
  </reference>
  <reference>
    <citation>Minen MT, Camprodon J, Nehme R, Chemali Z. The neuropsychiatry of tinnitus: a circuit-based approach to the causes and treatments available. J Neurol Neurosurg Psychiatry. 2014 Oct;85(10):1138-44. doi: 10.1136/jnnp-2013-307339. Epub 2014 Apr 17.</citation>
    <PMID>24744443</PMID>
  </reference>
  <reference>
    <citation>Llinas RR, Ribary U, Jeanmonod D, Kronberg E, Mitra PP. Thalamocortical dysrhythmia: A neurological and neuropsychiatric syndrome characterized by magnetoencephalography. Proc Natl Acad Sci U S A. 1999 Dec 21;96(26):15222-7. doi: 10.1073/pnas.96.26.15222.</citation>
    <PMID>10611366</PMID>
  </reference>
  <reference>
    <citation>Muhlnickel W, Elbert T, Taub E, Flor H. Reorganization of auditory cortex in tinnitus. Proc Natl Acad Sci U S A. 1998 Aug 18;95(17):10340-3. doi: 10.1073/pnas.95.17.10340.</citation>
    <PMID>9707649</PMID>
  </reference>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>May 17, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>January 6, 2023</last_update_submitted>
  <last_update_submitted_qc>January 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Irvine</investigator_affiliation>
    <investigator_full_name>Hamid Djalilian</investigator_full_name>
    <investigator_title>Professor, Neurotology and Skull Base Surgery</investigator_title>
  </responsible_party>
  <keyword>tinnitus</keyword>
  <keyword>medication</keyword>
  <keyword>randomized</keyword>
  <keyword>RCT</keyword>
  <keyword>trial</keyword>
  <keyword>migraine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tinnitus</mesh_term>
    <mesh_term>Migraine Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Topiramate</mesh_term>
    <mesh_term>Verapamil</mesh_term>
    <mesh_term>Paroxetine</mesh_term>
    <mesh_term>Nortriptyline</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04404439
org study id: HS# 2018-4458
nct id: NCT04404439
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Tinnitus represents one of the most common and distressing otologic problems, and it causes
      various somatic and psychological disorders that interfere with the quality of life. It is
      well-understood that many factors, such as poor education, lower income, or occupational, and
      recreational activity associated with high noise exposure, influences the prevalence and risk
      of tinnitus. Although the economic and emotional impact of tinnitus is large, there is
      currently no FDA-approved medication to treat this condition. However, there are
      pharmacological options to address the stress, anxiety, and depression that are caused by
      tinnitus. In this project, we intend to use medications for patients with tinnitus in order
      to decrease the impact of tinnitus on their daily life and activities.
This study is 8 weeks in duration. There are three arms in the experiment: the first is
      nortriptyline (7.5 mg) plus topiramate (10 mg), the second is verapamil (30 mg) plus
      paroxetine (4 mg), and the third is a placebo group. This is a double-blinded trial.
      Participants will be randomized to one arm for the duration of the trial using simple
      randomization with a computer-generated number. Both medication combinations and placebo may
      include dosage increases weekly if symptoms do not improve. Nortriptyline may be increased by
      7.5mg weekly (to a maximum of 60mg), topiramate by 10mg weekly (maximum 80mg), verapamil by
      30mg weekly (maximum 240mg), and paroxetine by 4mg weekly (maximum 32mg). Symptomatic survey
      scores from each arm will be obtained before and after treatment and weekly. An unblinded
      neurotologist attending (Dr. Harrison Lin) will also become involved with patients'
      treatments as they start to report changes in symptoms in order to monitor their safety and
      provide advice on change in dosage if patients have questions.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants will be assigned to a study group by chance (like a coin flip) rather than by a medical decision made by the researchers. There are three arms in the study (treatment group 1 which consists of nortriptyline + topiramate, treatment group 2 which consist of verapamil + paroxetine, and a placebo group), and participants enrolling in the trial will be randomly assigned in a 1:1:1 fashion to one of the arms. The participant will remain in the same arm for the duration of the study (8 weeks). There may be multiple participants in each arm who are undergoing the study at the same time (parallel model).
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Tinnitus Functional Index (TFI)
time frame: 8 weeks
description: Subjective improvement from baseline in tinnitus symptoms as measured by Tinnitus Functional Index (TFI). The TFI is scored from 0% to 100%, with higher scores indicating a more negative impact of tinnitus.
measure: Visual Analog Scale (VAS)
time frame: 8 weeks
description: Subjective improvement in tinnitus loudness severity based on a visual analog scale (VAS). The VAS is scored from 0 to 10, with a higher score representing an increased severity of tinnitus.
measure: Patient Health Questionnaire (PHQ)
time frame: 8 weeks
description: Subjective improvement in depression symptoms based on patient health questionnaire (PHQ). The PHQ is scored from 0 to 27, with a higher score indicating increased depression severity.
measure: Perceived Stress Scale (PSS)
time frame: 8 weeks
description: Subjective improvement in stress based on perceived stress scale (PSS). The PSS is scored from 0 to 40, with higher scores indicating higher perceived stress.
measure: Sleep Quality Index (SQI)
time frame: 8 weeks
description: Subjective improvement in sleep quality based on sleep quality index (SQI). The SQI is scored from 0 to 21, with higher scores indicating worse quality of sleep.
arm group label: Nortriptyline + topiramate
arm group type: Experimental
description: Nortriptyline (7.5 mg) plus topiramate (10 mg) in a single pill initially taken once daily. Dose may be increased as directed by care provider by 7.5mg weekly (to a maximum of 60mg) for nortriptyline, and by 10mg weekly (maximum 80mg) for topiramate.
arm group label: Verapamil + paroxetine
arm group type: Experimental
description: Verapamil (30 mg) plus paroxetine (4 mg) in a single pill initially taken once daily. Dose may be increased as directed by care provider by 30mg weekly (to a maximum of 240mg) for verapamil, and by 4mg weekly (maximum 32mg) for paroxetine.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo pill.
intervention type: Drug
intervention name: Nortriptyline + topiramate
description: Treatment group 1
arm group label: Nortriptyline + topiramate
intervention type: Drug
intervention name: Verapamil + paroxetine
description: Treatment group 2
arm group label: Verapamil + paroxetine
intervention type: Other
intervention name: Placebo
description: Placebo comparator
arm group label: Placebo
criteria: 
gender: All
minimum age: 25 Years
maximum age: 85 Years
healthy volunteers: No
last name: Hamid R Djalilian, MD
role: Principal Investigator
affiliation: Univeristy of California, Irvine
last name: Hamid R Djalilian, MD
phone: 800-263-9547
email: hdjalili@hs.uci.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: United States
citation: Evans RW, Ishiyama G. Migraine with transient unilateral hearing loss and tinnitus. Headache. 2009 May;49(5):756-8. doi: 10.1111/j.1526-4610.2008.01075.x. No abstract available.
PMID: 19472451
citation: Sindhusake D, Golding M, Newall P, Rubin G, Jakobsen K, Mitchell P. Risk factors for tinnitus in a population of older adults: the blue mountains hearing study. Ear Hear. 2003 Dec;24(6):501-7. doi: 10.1097/01.AUD.0000100204.08771.3D.
PMID: 14663349
citation: Dobie RA. A review of randomized clinical trials in tinnitus. Laryngoscope. 1999 Aug;109(8):1202-11. doi: 10.1097/00005537-199908000-00004.
PMID: 10443820
citation: Langguth B, Hund V, Busch V, Jurgens TP, Lainez JM, Landgrebe M, Schecklmann M. Tinnitus and Headache. Biomed Res Int. 2015;2015:797416. doi: 10.1155/2015/797416. Epub 2015 Oct 25.
PMID: 26583133
citation: Langguth B, Hund V, Landgrebe M, Schecklmann M. Tinnitus Patients with Comorbid Headaches: The Influence of Headache Type and Laterality on Tinnitus Characteristics. Front Neurol. 2017 Aug 28;8:440. doi: 10.3389/fneur.2017.00440. eCollection 2017.
PMID: 28894434
citation: Guichard E, Montagni I, Tzourio C, Kurth T. Association Between Headaches and Tinnitus in Young Adults: Cross-Sectional Study. Headache. 2016 Jun;56(6):987-94. doi: 10.1111/head.12845. Epub 2016 May 20.
PMID: 27197786
citation: Duckert LG, Rees TS. Treatment of tinnitus with intravenous lidocaine: a double-blind randomized trial. Otolaryngol Head Neck Surg. 1983 Oct;91(5):550-5. doi: 10.1177/019459988309100514.
PMID: 6417606
citation: Hallam RS, McKenna L, Shurlock L. Tinnitus impairs cognitive efficiency. Int J Audiol. 2004 Apr;43(4):218-26. doi: 10.1080/14992020400050030.
PMID: 15250126
citation: Muhlau M, Rauschecker JP, Oestreicher E, Gaser C, Rottinger M, Wohlschlager AM, Simon F, Etgen T, Conrad B, Sander D. Structural brain changes in tinnitus. Cereb Cortex. 2006 Sep;16(9):1283-8. doi: 10.1093/cercor/bhj070. Epub 2005 Nov 9.
PMID: 16280464
citation: Landgrebe M, Langguth B, Rosengarth K, Braun S, Koch A, Kleinjung T, May A, de Ridder D, Hajak G. Structural brain changes in tinnitus: grey matter decrease in auditory and non-auditory brain areas. Neuroimage. 2009 May 15;46(1):213-8. doi: 10.1016/j.neuroimage.2009.01.069. Epub 2009 Feb 12.
PMID: 19413945
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responsible party type: Principal Investigator
investigator affiliation: University of California, Irvine
investigator full name: Hamid Djalilian
investigator title: Professor, Neurotology and Skull Base Surgery
mesh term: Tinnitus
mesh term: Migraine Disorders
mesh term: Topiramate
mesh term: Verapamil
mesh term: Paroxetine
mesh term: Nortriptyline
sharing ipd: Undecided