Cochlear Promontory Stimulation for Treatment of Tinnitus: Towards Developing an Implantable Device
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tinnitus
- Sponsor
- Mayo Clinic
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Change in Short Term Relief of Tinnitus as Measured by the Tinnitus Handicap Inventory
- Status
- Completed
- Last Updated
- 7 months ago
Overview
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 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.
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 tinnitus, Distortion Product Otoacoustic Emissions (DPOAE) and Auditory Brainstem Response (ABR) testing prior to promontory stimulation. Head MRI, DPOAE, audiogram and immittance testing are considered clinically routine for assessment of asymmetric tinnitus. Temporal bone CT, ABR, tinnitus pitch, level matching, masking levels and residual inhibition testing are not standard clinical assessments for asymmetric tinnitus. In addition, subjects will complete the Tinnitus Handicap Inventory (THI), Tinnitus Functional Index (TFI) and Visual Analog Scale (VAS) questionnaires three separate times within the week prior to promontory stimulation testing. Additional testing for comorbid anxiety and depressive conditions will be a screening Generalized Anxiety Disorder (GAD7), Patient Health Questionnaire (PHQ8), and short Health Anxiety Inventory (HAI-S). The NEO Personality Inventory (NEO PI) will be administered to provide baseline information. 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. After these parameters are established, the patient will complete the THI, TFI, and VAS immediately prior to stimulation, during stimulation, and following completion of stimulation at 10-minutes, 1-hour, 24-hours, 48-hours, and 1-week following completion of stimulation. In addition, pitch and level matching of tinnitus will be completed immediately upon completion of each promontory stimulation session. Each patient will undergo three successive treatments separated by 1-week. Prior to each treatment, the patient will receive an audiogram and DPOAE testing to document interval safety. At the conclusion of the study, subjects will be asked about their willingness to undergo surgical implantation of a device capable of long-term scheduled or on-demand electrical stimulation for tinnitus suppression
Investigators
Matthew L. Carlson, M.D.
Principal Investigator
Mayo Clinic
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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:
- •have a past history of clinically diagnosed depression or anxiety that is no longer currently active; or
- •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)
Outcomes
Primary Outcomes
Change in Short Term Relief of Tinnitus as Measured by the Tinnitus Handicap Inventory
Time Frame: Baseline to 4 months
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). Total score ranges from 0 to 100 with higher scores indicating a worse outcome.
Secondary Outcomes
- Optimal Location of Tinnitus Relief(Immediately after electrical stimulation procedure (approximately 1 min after stimulation))
- Auditory Feedback(Immediately after electrical stimulation procedure (approximately 1 min after stimulation))
- Tactile Feedback(Immediately after electrical stimulation procedure (approximately 1 min after stimulation))
- Change in Short Term Relief of Tinnitus as Measured by the Tinnitus Functional Index(Baseline to 4 months)
- Change in Short Term Relief of Tinnitus as Measured by the Visual Analog Scale(Baseline to 4 months)