Clinical Trial of Etanercept (TNF-α Blocker) for Treatment of Blast-Induced Tinnitus
Wayne State University
Summary
The purpose of this multi-site research study is to determine if Etanercept, compared to a placebo, significantly reduces the severity of tinnitus (ringing in the ears) associated with history of blast and/or noise exposure or associated with Traumatic Brain Injury (TBI) and/or concussion. Individuals who qualify will be randomized into one of two groups: The group receiving the medication Etanercept or the group receiving a saline solution placebo.
Description
The primary objectives are to test if: 1) Etanercept significantly reduces tinnitus distress as measured by Tinnitus Functional Index (TFI); and 2) Etanercept improves hearing. In addition, the investigators will explore whether Etanercept treatment leads to sustained therapeutic effects over time; The secondary objective is to test if: 1) Etanercept reduces tinnitus loudness measured by visual numeric scale (VNS) rating.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Tinnitus of at least a moderate severity as defined by a score of ≥ 25 points or higher on the Tinnitus Functional Index (TFI) questionnaire associated with one or more of the following: 1. Blast- or noise exposure 2. Traumatic brain injury (TBI) and/or concussion diagnosed by a health care provider. 2. Able to provide written informed consent. 3. Age: Minimum 18 years of age at the time of enrollment. 4. Other concurrent treatments for tinnitus: A four-week washout from any other tinnitus treatment or management program is required prior to entering this study.…
Interventions
- BiologicalEtanercept
To treat blast or noise induced tinnitus
- OtherSaline
Placebo
Locations (4)
- Advent HealthCelebration, Florida
- University of MiamiCoral Gables, Florida
- Wayne State UniversityDetroit, Michigan
- Michigan Ear InstituteFarmington Hills, Michigan