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Investigating the Neurobiology of Tinnitus

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ClinicalTrials.gov Identifier: NCT01294124
Recruitment Status : Not yet recruiting
First Posted : February 11, 2011
Last Update Posted : December 9, 2014
Information provided by (Responsible Party):

Study Description
Brief Summary:

The investigators hypothesize that individual differences exist in resting-state cortical attention, control, sensory, and emotion networks prior to noise exposure and these differences predispose some to the development of bothersome tinnitus. Furthermore, the investigators hypothesize that these changes in functional connectivity of these vulnerable systems after noise exposure are responsible for tinnitus. The proposed study will use a case-control cohort study design. Cases will be those soldiers who develop tinnitus and controls will be those who do not. This will be the first prospective study of tinnitus and will provide important information about the neurobiology of tinnitus.

If a cortical neural network etiology for bothersome tinnitus is confirmed, it will be an astounding, powerful, paradigm shifting model for the diagnosis, prevention and, most importantly, treatment of tinnitus. Furthermore, if a battery of neurocognitive tests can identify soldiers at risk for the development of tinnitus then appropriate primary prevention strategies can be introduced.

There are three Specific Aims to this project.

Specific Aim 1. To determine if soldiers who develop tinnitus display pre-deployment differences in a set of physical, functional, cognitive, vulnerability, perpetuating factors, pre-deployment neurocognitive scores, or neuroimaging features compared to soldiers who do not develop tinnitus ("control group").

Specific Aim 2. To determine if particular scores on neurocognitive tests or neuroimaging features of functional/structural connectivity networks are associated with the development of tinnitus.

Specific Aim 3. To identify a set of pre-deployment physical, functional, cognitive, vulnerability, and perpetuating factors, neurocognitive responses, and neuroimaging features that are associated with the development of tinnitus.

The investigators plan to recruit 200 soldiers, between the ages of 18 and 30 years who do not have hearing loss or tinnitus and have never been deployed to military theater. The soldier participants will undergo a variety of tests before and after deployment, which will include a hearing test, neurocognitive tests (i.e., brain function tests), and a variety of novel radiologic imaging studies of the brain. One of these novel radiologic imaging studies is functional connectivity Magnetic Resonance Imaging, a proven methodology that monitors changes in brain activity and connections based on blood flow between different brain areas and levels of consumption of oxygen. This information is used to describe the condition of important neural networks responsible for such things as attention, mood, sensation, vision, hearing, and introspection or self-contemplation.

Condition or disease
Tinnitus Traumatic Brain Injury Post Traumatic Stress Disorder

Study Design

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Investigating The Neurobiology of Tinnitus
Study Start Date : March 2015
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus
U.S. FDA Resources

Groups and Cohorts

No Tinnitus
The absence of tinnitus will be based on the participants' responses to questions 8a, 9c, and 9d of the Post-Deployment Health Assessment (PDHA).
The presence of tinnitus will be based on the participants' responses to questions 8a, 9c, and 9d of the Post-Deployment Health Assessment (PDHA).

Outcome Measures

Primary Outcome Measures :
  1. Development of Tinnitus [ Time Frame: Post-deployment assessment will occur no sooner than 90 days from return from active military theater. ]
    The presence of tinnitus will be based on the participants' responses to questions 8a, 9c, and 9d of the Post-Deployment Health Assessment (PDHA).

Secondary Outcome Measures :
  1. Mild Traumatic Brain Injury [ Time Frame: Post-deployment assessment will occur no sooner than 90 days from return from active military theater. ]
    Mild Traumatic Brain Injury - Ohio State University TBI Identification Method (OSU TBI-ID version 12-10-08)(Corrigan and Bogner 2007)

  2. Post Traumatic Stress Disorder [ Time Frame: Post-deployment assessment will occur no sooner than 90 days from return from active military theater. ]
    Subjects whose military medical record or PDHA suggests PTSD will be asked to complete the Clinician Administered PTSD Scale (CAPS).(Blake et al. 1995; Weathers and Litz 1994)

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Active-duty or reserve United States military personnel between the ages of 18 and 30 of either sex, all races and ethnicity, who are scheduled for initial deployment to theater with a Military Occupational Specialty code (MOS) of 11B Infantryman, 11C Indirect Fire Infantryman, 19D Calvary Scout, or 19K Armor Crewman.

Inclusion Criteria:

  • Active duty or reserve military personnel with MOS job code 11B, 11C, 19D, or 19K
  • Men and women between the ages of 18 and 30 years
  • Scheduled for first deployment to military theater
  • Must be able to read, write, and understand English
  • Willing to sign Request Pertaining to Military Records (Form 180) to allow study personnel to access medical records for the purposes of this study.

Exclusion Criteria:

  • History of hearing loss or tinnitus
  • Currently taking medication for depression, anxiety, or other DSM IV Axis 1 disorder
  • History of head trauma sufficient to cause loss of consciousness for 30 minutes or greater
  • History of surgery to the brain
  • History of claustrophobia
  • Presence of metallic implants in the head and upper cervical region that are non-MRI compatible and would prohibit use of MRI.
  • At any time in the past, prior deployment or employment in military theater
  • Currently pregnant
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01294124

Contact: Sara Kululjan, BS, RN,CCRC 314-362-7563 kukuljans@ent.wustl.edu

United States, California
Naval Medical Center Not yet recruiting
San Diego, California, United States, 92134
Contact: Sara Murphy, MPH    619-532-6820    sara.murphy.ctr@med.navy.mil   
Principal Investigator: Sean Wise, CAPT, MD         
United States, Missouri
Washington University School of Medicine Not yet recruiting
St. Louis, Missouri, United States, 63110
Contact: Sara Kukuljan, BS, RN    314-362-7563    kukuljans@ent.wustl.edu   
Principal Investigator: Jay F Piccirillo, MD, CPI         
Sponsors and Collaborators
Washington University School of Medicine
United States Department of Defense
Principal Investigator: Jay F. Piccirillo, MD Washington University School of Medicine
Principal Investigator: Sean Wise, CAPT., M.D. United States Naval Medical Center, San Diego
More Information

Responsible Party: Jay F. Piccirillo, MD, Professor, Washington University School of Medicine, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01294124     History of Changes
Other Study ID Numbers: 201101920DM.INT
CDMRP ( Other Grant/Funding Number: DM102565 )
First Posted: February 11, 2011    Key Record Dates
Last Update Posted: December 9, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Brain Injuries
Brain Injuries, Traumatic
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Trauma and Stressor Related Disorders
Mental Disorders
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Signs and Symptoms