Investigating the Neurobiology of Tinnitus
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|ClinicalTrials.gov Identifier: NCT01294124|
Recruitment Status : Completed
First Posted : February 11, 2011
Last Update Posted : December 16, 2019
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 Type :||Observational|
|Actual Enrollment :||218 participants|
|Official Title:||Investigating The Neurobiology of Tinnitus|
|Actual Study Start Date :||May 25, 2016|
|Actual Primary Completion Date :||July 12, 2019|
|Actual Study Completion Date :||July 12, 2019|
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).
- 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).
- 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)
- 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)
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
|United States, California|
|Naval Medical Center|
|San Diego, California, United States, 92134|
|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|