Status:
COMPLETED
Cochlear Promontory Stimulation for Treatment of Tinnitus
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
United States Department of Defense
Conditions:
Tinnitus
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Tinnitus is the perception of sound when no external noise is present. The Center for Disease Control (CDC) estimates over 50 million - nearly 15% of the general public -experience some form of tinnit...
Detailed Description
Candidate subjects will undergo a temporal bone Computed Tomography (CT) scan, contrast enhanced head Magnetic Resonance Imaging (MRI), audiogram with immittance testing, pitch and level matching of t...
Eligibility Criteria
Inclusion
- Normal to moderate sensorineural hearing loss (based on pure tone audiometry (PTA) of 500, 1000 and 2000 Hz) and a word recognition score equal to or greater than 60%
- Asymmetric or unilateral subjective tonal tinnitus
- Tinnitus that is disruptive
- Determined by THI score (in the severe range i.e. ≥56/100)
- TFI (in the severe range i.e. ≥52/100)
- Tinnitus VAS (≥ 5/10 )
- Tinnitus that is intractable, and has not been ameliorated by conventional measures such as a hearing aid or masking
- Normal contrast-enhanced MRI of the head
Exclusion
- Tinnitus present less than 6 months or longer than 12 years; it is permissible to include people who have had intermittent or constant tinnitus longer than 12 years as long as it was not perceived as severe longer than 12 years
- History of brain or major ear surgery
- Prior major head trauma
- Ongoing clinical diagnosis of depression or anxiety; for the purposes of this study, it is permissible to include people who: 1. have a past history of clinically diagnosed depression or anxiety that is no longer currently active; or 2. people who have depressive or anxious symptoms that are thought to primarily result from severe tinnitus
- a. Determined by screening using the GAD 7, PHQ8, and HAI-S
- GAD7 \> 9 (indicates clinically significant anxiety)
- PHQ \> 9 (indicates clinically significant depression)
- HAI-S \> 25 (hypochondriacal level illness anxiety)
- Inability to assess, continue or complete trial
- Currently on regularly scheduled antidepressants, anxiolytics or antipsychotics; for this study, it is permissible to include people who use such medications at lower doses as a sleep aid or for people who intermittently use such medications for situational anxiety (e.g., Ativan before airplane travel)
- Active use of other tinnitus treatments; for the purposes of this study it is permissible to include people who prefer to use a hearing aid to amplify ipsilateral hearing loss
- Known pregnancy
Key Trial Info
Start Date :
January 4 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 13 2024
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03759834
Start Date
January 4 2018
End Date
August 13 2024
Last Update
September 10 2025
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905