TNF-α Treatment of Blast-Induced Tinnitus

Eligibility 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.
• 5. Hearing function: All degrees of hearing function can be included, recognizing that individuals with profound, bilateral hearing loss will not be able to perform tinnitus evaluations and hearing tests but will be able to rate subjective tinnitus loudness, annoyance and impact on life. This is an important sub-population because of the challenges in treating them with acoustic therapy and the need for a medical intervention.
• 6. Additional tinnitus characteristics:
• 1. History or evidence of any of the following: Significant brain malformation; cerebral vascular events (such as strokes); neurodegenerative disorders affecting the brain, such as Parkinson's disease, ALS, or Huntington's disease; multiple sclerosis, Guillain-Barré syndrome, or any other disease involving demyelination disorder or any finding suggesting a demyelination disease or disorder; prior brain surgery.
• 2. Active malignant neoplasm such as lymphoma or solid tumors or history of malignant neoplasm, excluding successfully treated squamous cell carcinoma or basal carcinoma of the skin or cervical cancer.
• 3. Diagnosis of congestive heart failure.
• 4. History of diagnosed seizure disorder or epilepsy.
• 5. Diagnosis of myelodysplastic syndrome or aplastic anemia, white blood cell count \< 4000, or platelet count \< 150,000.
• 6. Subjects who currently have an active infection, including tuberculosis, HIV, hepatitis B, and/or chicken pox.
• 7. Scheduled to receive a live vaccine during study participation or received a live vaccine within 2 weeks prior to screening visit/procedures.
• 8. Diagnosis of an auto-immune disease that, in the opinion of the investigator, would cause a weakened immune system.
• 9. Diabetes.
• 10. Ongoing treatment with or plans to begin taking any of the following contraindicated medications: Cyclophosphamide or sulfasalazine; abatacept, anakinra, or any other immunomodulatory biologic therapy; sulfonylureas, meglitinides, or insulin.
• 11. Subjects who cannot communicate reliably with research team members or who are not likely to be able to complete the requirements of the trial per the discretion of the investigator.
• 12. Subjects who have participated in a drug clinical trial within the last 30 days before the start of this one.
• 13. Pregnancy or planned pregnancy during the study.
• 14. Women who are lactating or are of child-bearing-age without use of contraception.
• 15. MMSE score \< 24.
• 16. Clinically significant out of range laboratory values for protocol required laboratory tests as assessed by the investigator.