TNF-α Treatment of Blast-Induced Tinnitus

Exclusion Criteria

• •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.
• •a. The following surgical procedures are not exclusionary: Evacuation of subdural hematoma, insertion of intracranial pressure monitor device, craniectomy
• •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.
• •a. Patients with latent hepatitis B infection are also excluded from participation.
• •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.
• •a) Autoimmune thyroid disease is not considered an exclusionary autoimmune disease for participation in this study.
• •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.