Investigating the Neurobiology of Tinnitus

This study is not yet open for participant recruitment.
Verified January 2014 by Washington University School of Medicine
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jay F. Piccirillo, MD, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01294124
First received: February 9, 2011
Last updated: January 14, 2014
Last verified: January 2014
  Purpose

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
Tinnitus
Traumatic Brain Injury
Post Traumatic Stress Disorder

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Investigating The Neurobiology of Tinnitus

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Development of Tinnitus [ Time Frame: Post-deployment assessment will occur no sooner than 90 days from return from active military theater. ] [ Designated as safety issue: No ]
    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:
  • Mild Traumatic Brain Injury [ Time Frame: Post-deployment assessment will occur no sooner than 90 days from return from active military theater. ] [ Designated as safety issue: No ]
    Mild Traumatic Brain Injury - Ohio State University TBI Identification Method (OSU TBI-ID version 12-10-08)(Corrigan and Bogner 2007)

  • Post Traumatic Stress Disorder [ Time Frame: Post-deployment assessment will occur no sooner than 90 days from return from active military theater. ] [ Designated as safety issue: No ]
    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)


Estimated Enrollment: 300
Study Start Date: September 2014
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Groups/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).
Tinnitus
The presence of tinnitus will be based on the participants' responses to questions 8a, 9c, and 9d of the Post-Deployment Health Assessment (PDHA).

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Both
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.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01294124

Contacts
Contact: Joyce R. Nicklaus, RN,BSN,CCRC 314-362-7508 nicklausj@ent.wustl.edu

Locations
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: Michael Hoffer, CAPT, MD         
United States, Missouri
Washington University School of Medicine Not yet recruiting
St. Louis, Missouri, United States, 63110
Contact: Joyce Nicklaus, RN, BSN    314-362-7508    nicklausj@ent.wustl.edu   
Principal Investigator: Jay F Piccirillo, MD, CPI         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Jay F. Piccirillo, MD Washington University
  More Information

No publications provided

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
Study First Received: February 9, 2011
Last Updated: January 14, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 17, 2014