Health TrialsbyHealthPanel

TNF-α Treatment of Blast-Induced Tinnitus

ConditionTinnitus, Noise Induced
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorWayne State University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Blast- or noise exposure

Traumatic brain injury (TBI) and/or concussion diagnosed by a health care provider.

Able to provide written informed consent.

Age: Minimum 18 years of age at the time of enrollment.

Disqualifiers

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.

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.

Diagnosis of congestive heart failure.

History of diagnosed seizure disorder or epilepsy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Etanercept

    Biological/Vaccine

    To treat blast or noise induced tinnitus

  • Saline

    Other intervention

    Placebo

Treatment groups

88 Participants
are divided into 2 treatment groups
Group A: Etanercept Injection GroupExperimental treatment 1 intervention
Group B: Placebo Injection GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Tinnitus Functional Index (TFI)

Self-report questionnaire used to assess the severity and negative impact of tinnitus (tinnitus distress). It uses an 11 point Likert scale with higher scores indicating more severe tinnitus (For example, "How strong or loud was your tinnitus?", 0 (Not at all strong or loud)-10 (Extremely strong or loud).

Time frame
12 Weeks

Secondary outcomes

1

Audiometric testing

Pure tone air conduction (AC) testing; Pure tone bone conduction (BC) testing; Speech recognition threshold (SRT); Tympanometry; Word recognition testing

Time frame
12 Weeks
2

Tinnitus Testing

Tinnitus loudness matching (1 kHz loudness-matching); Minimum Masking Levels (MMLs)

Time frame
12 Weeks
3

Visual Numeric Rating Scale

Self-rated visual numeric scale that asks respondents to rate the loudness of their tinnitus on a scale from 0 (No Tinnitus) to 10 (Very Loud). Higher scores indicate louder/more severe tinnitus.

Time frame
12 Weeks
4

Tinnitus Primary Function Questionnaire

Self-report questionnaire assessing primary activities impaired by tinnitus. The questionnaire uses a self report number scale (1-100) asking respondents to indicate their agreement with each statement on a scale from 0 (completely disagree) to 100 (completely agree). Higher scores indicate worse tinnitus/more functional impairment from tinnitus.

Time frame
12 Weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wayne State University

Lead sponsor

University of Miami

Collaborator

Michigan Ear Institute

Collaborator

Source ClinicalTrials.gov
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