Investigating the Neurobiology of Tinnitus

Sponsor

Washington University School of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT01294124

Collaborator

United States Department of Defense (U.S. Fed)

218

Enrollment

Location

37.6

Actual Duration (Months)

5.8

Patients Per Site Per Month

Study Details

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	Intervention/Treatment	Phase
Tinnitus Traumatic Brain Injury Post Traumatic Stress Disorder

Study Design

Study Type:

Observational

Actual Enrollment :

218 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Investigating The Neurobiology of Tinnitus

Actual Study Start Date :

May 25, 2016

Actual Primary Completion Date :

Jul 12, 2019

Actual Study Completion Date :

Jul 12, 2019

Arms and Interventions

Arm	Intervention/Treatment
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).

Outcome Measures

Primary Outcome Measures

Development of Tinnitus [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

Mild Traumatic Brain Injury [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)
Post Traumatic Stress Disorder [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

Criteria

Ages Eligible for Study:

18 Years to 30 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Naval Medical Center	San Diego	California	United States	92134

Sponsors and Collaborators

Washington University School of Medicine
United States Department of Defense

Investigators

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