AdventHealth Research Institute Offers Phase II Clinical Trial of Etanercept for Treatment of Blast-Induced Tinnitus
Under the leadership of principal investigator Michael Seidman, MD, AdventHealth Research Institute is participating in the multi-site Clinical Trial of Etanercept (TNF-alpha Blocker) for Treatment of Blast-Induced Tinnitus funded by the U.S. Department of Defense.
The purpose of this 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. The primary objectives are to test if:
The secondary objective of this study is to test if etanercept reduces tinnitus loudness measured by visual numeric scale (VNS) rating.
- Etanercept significantly reduces tinnitus distress as measured by the Tinnitus Functional Index (TFI), a self-report questionnaire used to assess the severity and negative impact of tinnitus (tinnitus distress).
- Etanercept improves hearing as measured through audiometric testing, tinnitus testing, a visual numeric rating scale to rate the loudness of the tinnitus, and a tinnitus primary function questionnaire. In addition, investigators will explore whether etanercept treatment leads to sustained therapeutic effects over time.