TNF-α Treatment of Blast-Induced Tinnitus

Launched by WAYNE STATE UNIVERSITY · Aug 20, 2019

Keywords

ClinConnect Summary

This clinical trial is studying whether a medication called Etanercept can help reduce the severity of tinnitus, which is a ringing or buzzing sound in the ears. This trial is specifically looking at people who have tinnitus related to exposure to loud blasts or noise, as well as those with a history of traumatic brain injury (TBI) or concussion. Participants will be randomly assigned to receive either Etanercept or a placebo, which is a harmless saline solution that looks like the medication but has no active ingredients.

To be eligible for the trial, participants must be at least 18 years old and have moderate to severe tinnitus as measured by a specific questionnaire. They should also have a history of noise or blast exposure or a diagnosed TBI or concussion. Participants need to be able to understand the study and provide consent, and they should not have certain medical conditions that could interfere with the trial. If you decide to join, you can expect regular check-ins to assess your tinnitus and overall health. This study is actively looking for participants, so it may be a good opportunity for those struggling with tinnitus related to specific causes.

Gender

ALL

Eligibility criteria

• 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.
• • a) Hearing aids are permitted if the participant has been wearing them for at least 4 weeks.
• • 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:
• • a) Tinnitus history: Onset associated with blast and/or noise exposure or associated with diagnosed TBI and/or concussion. Subjects will have blast exposure, noise exposure, traumatic brain injury (TBI), and/or concussion impact, defined as exposure/impact less than or longer than six months at time of enrollment.
• • i. Participants enrolled with tinnitus associated with TBI and/or concussion must have received a diagnosis of TBI and/or concussion by a health care provider.
• • b) Stability: Constant (not pulsatile or intermittent). c) Location of tinnitus perception: Unrestricted. Tinnitus may be unilateral, bilateral, or perceived in the head.
• 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.