RECRUITING

TNF-α Treatment of Blast-Induced Tinnitus

Conditions

Tinnitus, Noise Induced tinnitus etanercept tinnitus function index tinnitus primary function audiological evaluation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this multi-site 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. Individuals who qualify will be randomized into one of two groups: The group receiving the medication Etanercept or the group receiving a saline solution placebo.

Official Title

Clinical Trial of Etanercept (TNF-α Blocker) for Treatment of Blast-Induced Tinnitus

Quick Facts

Study Start:2022-07-01

Study Completion:2025-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04066348

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Jamal Chehab

CONTACT

313-577-5495

tinnitustrial@wayne.edu

Principal Investigator

Jinsheng Zhang, Ph. D.

PRINCIPAL_INVESTIGATOR

Wayne State University

Study Locations (Sites)

University of Miami

Coral Gables, Florida, 33124

United States

Wayne State University

Detroit, Michigan, 48201

United States

Michigan Ear Institute

Farmington Hills, Michigan, 48334

United States

Collaborators and Investigators

Sponsor: Wayne State University

Jinsheng Zhang, Ph. D., PRINCIPAL_INVESTIGATOR, Wayne State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-01

Study Completion Date2025-09

Study Record Updates

Study Start Date2022-07-01

Study Completion Date2025-09

Terms related to this study

Keywords Provided by Researchers

tinnitus
etanercept
tinnitus function index
tinnitus primary function
audiological evaluation

Additional Relevant MeSH Terms

Tinnitus, Noise Induced