Cochlear Promontory Stimulation for Treatment of Tinnitus
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|ClinicalTrials.gov Identifier: NCT03759834|
Recruitment Status : Suspended (Enrollment for study is currently on hold pending additional funding and resources.)
First Posted : November 30, 2018
Last Update Posted : January 21, 2022
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 tinnitus. Roughly 20 million people struggle with burdensome chronic tinnitus, with 2 million experiencing extreme and debilitating symptoms.
The 2014 Clinical Practice Guideline on tinnitus from the American Academy of Otolaryngology - Head and Neck Surgery summarized the existing state of tinnitus management by stating "A cure for primary tinnitus does not yet exist, and despite claims to the contrary, no method has been proven to provide long-term suppression of tinnitus."
The purpose of this study is to look at the safety and efficacy of cochlear promontory stimulation in the short term relief of tinnitus. The secondary goal of the study is to determine the optimum region(s) of the cochlear promontory in planning for an implantable electrical device for long term tinnitus suppression.
|Condition or disease||Intervention/treatment||Phase|
|Tinnitus||Device: Cochlear promontory stimulation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||The electrode will be placed in the middle ear. The patient and investigator will be blinded to the "on-off" status of the device. The patient will report if they have improvement of their tinnitus while both the patient and investigator are blinded to the "on-off" status.|
|Official Title:||Cochlear Promontory Stimulation for Treatment of Tinnitus: Towards Developing an Implantable Device|
|Actual Study Start Date :||January 4, 2018|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||June 2022|
Experimental: Testing Arm
There will only be one arm. The patient and investigator will initially be blinded to the "on-off" status of the electrode. The patient will thus serve as an internal control for testing. Once device integrity and possible benefit is confirmed, the patients will undergo non-tactile electrical stimulation to the bone of the inner ear (cochlear promontory) for short term relief of tinnitus via Cochlear promontory stimulation.
Device: Cochlear promontory stimulation
Promontory stimulation is an established otologic procedure that was initially developed as a diagnostic tool to assess patient candidacy for cochlear implantation. Promontory stimulation is most commonly performed in the outpatient setting on an awake patient by placing a single insulated probe through a topically anesthetized tympanic membrane and applying monopolar current for several seconds to minutes. The initial session of promontory stimulation will define optimal stimulation parameters (i.e., location, current level, pulse-width, phase polarity), where maximal tinnitus suppression occurs with minimal or no auditory percept. Additional stimulation testing visits will confirm these findings.
- Short Term Relief of Tinnitus as Measured by the Tinnitus Handicap Inventory [ Time Frame: 7 days after electrical stimulation procedure ]The Tinnitus Handicap Inventory (THI) has 25 questions with possible answers of Yes (4 points), Sometimes (2 points), and No (0 points). Scores categories are (1-16: Slight or no handicap - Grade 1), (18-36: Mild handicap - Grade 2), (38-56: Moderate handicap - Grade 3), (58-76: Severe handicap - Grade 4), (78-100: Catastrophic handicap - Grade 5).
- Optimal Location of Tinnitus Relief [ Time Frame: Immediately after electrical stimulation procedure (approximately 1 min after stimulation) ]Location on the cochlear promontory where highest perceived benefit from electrical stimulation
- Auditory Feedback [ Time Frame: Immediately after electrical stimulation procedure (approximately 1 min after stimulation) ]Perception of hearing the electrical stimulus (if at all)
- Tactile Feedback [ Time Frame: Immediately after electrical stimulation procedure (approximately 1 min after stimulation) ]Perception of hearing the electrical stimulus (if at all)
- Short Term Relief of Tinnitus as Measured by the Tinnitus Functional Index [ Time Frame: 7 days after electrical stimulation procedure ]The Tinnitus Functional Index (TFI) contains eight subscales (domains), of which seven contain 3 items and one contains 4. The possible responses for each item range from 0 (did not interfere) to 10 (completely interfered). The total score is transformed to a scale ranging from 0 (no interference) to 100 (completely interfered with activities).
- Short Term Relief of Tinnitus as Measured by the Visual Analog Scale [ Time Frame: 7 days after electrical stimulation procedure ]The Visual Analog Scale (VAS) for Numeric Pain Distress was used for this outcome. The VAS has pre-set marks between the extremes of 0 (no pain) and 10 (unbearable pain).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03759834
|United States, Minnesota|
|Mayo Clinic in Rochester|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Matthew L Carlson||Mayo Clinic|