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:
- 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.
The secondary objective of this study is to test if etanercept reduces tinnitus loudness measured by visual numeric scale (VNS) rating.
Challenges in Treating Tinnitus
Defined as the perception of sound that does not have an external source, tinnitus is most often described as a ringing sound, and there is currently no cure. Management and treatment options include counseling, relaxation therapy, habituation therapies, tinnitus maskers, biofeedback, hypnosis, and electrical stimulation. Currently, there are no FDA-approved pharmacological treatments for the condition.
“Tinnitus can disrupt daily life and have debilitating effects on emotional and psychological well-being,” shares Dr. Seidman. “Many who suffer from it have trouble concentrating or sleeping, and over time, this can lead to anxiety and depression.”
Military personnel and veterans are especially prone to tinnitus as blast-related is the “signature injury,” and chronic tinnitus and hearing loss are the most common auditory-related co-morbidities.
“Approximately 1 billion people throughout the world suffer from tinnitus, and it is the number one disability of those who serve in our military,” adds Dr. Seidman. “In fact, the U.S. Department of Veterans Affairs spends hundreds of million dollars per year on tinnitus-related disability compensation to veterans, creating a significant economic burden.”
About Etanercept
A tumor necrosis factor (TNF) blocker, etanercept has been approved by the U.S. Food and Drug Administration (FDA) for use in the treatment of several inflammatory conditions, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis. In humans, it has been shown that TNF-alpha contributes to autoimmune cochleovestibular disorders, including hearing loss and tinnitus.
“A number of studies suggest that blocking TNF-alpha not only down-regulates excessive inflammatory responses but also modulates maladaptive neural plasticity that manifests in response to chronic stress from hearing loss or tinnitus associated with noise trauma,” explains Dr. Seidman. “In this study, we will be testing the hypothesis that blocking TNF-alpha could reduce the severity of tinnitus for prolonged periods of time.”
Study Design and Participation
This Phase II clinical trial will enroll military personnel, veterans and civilians who suffer from tinnitus associated with blast exposure and/or noise trauma. Participants who qualify for the study after completing all screening procedures will be randomly assigned to receive either 50 mg of etanercept or a placebo once a week for 12 consecutive weeks. The medication will be administered by a nurse or physician as a subcutaneous injection. Participation in the study will last about 36 weeks, and individuals who qualify will come in for about 17 study visits.
“We’re excited to participate in this important national research effort and remain committed to exploring potential new treatments that could improve quality of life for people throughout the country,” says Dr. Seidman.
To learn more about this clinical trial, including the full inclusion and exclusion criteria, visit https://www.adventhealth.com/institute/adventhealth-research-institute/digestive-health-and-surgery/clinical-trials/4510-pr172190-clinical-trial-etanercept-tnf-a-blocker-treatment-blast-induced-tinnitus.
