Investigating the Neurobiology of Tinnitus

Traumatic Brain Injury Clinical Trial

Official title:

Investigating The Neurobiology of Tinnitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01294124
• Other study ID #: NMCSD.2013.0021
• Secondary ID: CDMRP
• Status: Completed
• Start date: May 25, 2016
• Est. completion date: July 12, 2019

Study information

• Verified date: December 2019
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: July 12, 2019
• Est. primary completion date: July 12, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Tinnitus
• Traumatic Brain Injury

Locations

Country	Name	City	State
United States	Naval Medical Center	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of 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).	Post-deployment assessment will occur no sooner than 90 days from return from active military theater.
Secondary	Mild Traumatic Brain Injury	Mild Traumatic Brain Injury - Ohio State University TBI Identification Method (OSU TBI-ID version 12-10-08)(Corrigan and Bogner 2007)	Post-deployment assessment will occur no sooner than 90 days from return from active military theater.
Secondary	Post Traumatic Stress Disorder	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)	Post-deployment assessment will occur no sooner than 90 days from return from active military theater.