Tinnitus
Conditions
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
Interventions
DEVICECochlear 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.
Sponsors
United States Department of Defense
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. 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% 2. Asymmetric or unilateral subjective tonal tinnitus 3. Tinnitus that is disruptive 1. Determined by THI score (in the severe range i.e. ≥56/100) 2. TFI (in the severe range i.e. ≥52/100) 3. Tinnitus VAS (≥ 5/10 ) 4. Tinnitus that is intractable, and has not been ameliorated by conventional measures such as a hearing aid or masking 5. Normal contrast-enhanced MRI of the head
Exclusion criteria
1. 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 2. History of brain or major ear surgery 3. Prior major head trauma 4. 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) 5. Inability to assess, continue or complete trial 6. 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) 7. 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 8. Known pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Short Term Relief of Tinnitus as Measured by the Tinnitus Handicap Inventory | 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
| Measure | Time frame | Description |
|---|---|---|
| Optimal Location of Tinnitus Relief | Immediately after electrical stimulation procedure (approximately 1 min after stimulation) | Location on the cochlear promontory where highest perceived benefit from electrical stimulation |
| Auditory Feedback | Immediately after electrical stimulation procedure (approximately 1 min after stimulation) | The number of subjects that reported hearing the electrical stimulus (if at all) |
| Tactile Feedback | Immediately after electrical stimulation procedure (approximately 1 min after stimulation) | The number of subjects that reported feeling the electrical stimulus (if at all) |
| Change in Short Term Relief of Tinnitus as Measured by the Tinnitus Functional Index | Baseline to 4 months | 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). |
| Change in Short Term Relief of Tinnitus as Measured by the Visual Analog Scale | Baseline to 4 months | The Visual Analog Scale (VAS) for Numeric Pain Distress was used for this outcome. The VAS is a 11-item questionnaire assessing pain. Using a scale of 0 (no pain) and 10 (unbearable pain). Total scores range from 0 - 110, lower scores indicating lower pain and higher scores indicating greater pain. |
Countries
United States
Participant flow
Pre-assignment details
Three participants withdrew consent prior to starting treatment.
Participants by arm
| Arm | Count |
|---|---|
| Testing Arm There was one arm. The patient and investigator were initially blinded to the on-off status of the electrode. The patient served as an internal control for testing. Once device integrity and possible benefit was confirmed, the patients underwent non-tactile electrical stimulation to the bone of the inner ear (cochlear promontory) for short term relief of tinnitus via Cochlear promontory stimulation.
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. | 22 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Testing Arm |
|---|---|
| Age, Continuous | 59 years STANDARD_DEVIATION 8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 21 Participants |
| Region of Enrollment United States | 22 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 22 |
| other Total, other adverse events | 0 / 22 |
| serious Total, serious adverse events | 0 / 22 |
Outcome results
Primary
Change in Short Term Relief of Tinnitus as Measured by the Tinnitus Handicap Inventory
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.
Time frame: Baseline to 4 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Testing Arm | Change in Short Term Relief of Tinnitus as Measured by the Tinnitus Handicap Inventory | -31 score on a scale |
Secondary
Auditory Feedback
The number of subjects that reported hearing the electrical stimulus (if at all)
Time frame: Immediately after electrical stimulation procedure (approximately 1 min after stimulation)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Testing Arm | Auditory Feedback | 22 Participants |
Secondary
Change in Short Term Relief of Tinnitus as Measured by the Tinnitus Functional Index
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).
Time frame: Baseline to 4 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Testing Arm | Change in Short Term Relief of Tinnitus as Measured by the Tinnitus Functional Index | -35 score on a scale |
Secondary
Change in Short Term Relief of Tinnitus as Measured by the Visual Analog Scale
The Visual Analog Scale (VAS) for Numeric Pain Distress was used for this outcome. The VAS is a 11-item questionnaire assessing pain. Using a scale of 0 (no pain) and 10 (unbearable pain). Total scores range from 0 - 110, lower scores indicating lower pain and higher scores indicating greater pain.
Time frame: Baseline to 4 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Testing Arm | Change in Short Term Relief of Tinnitus as Measured by the Visual Analog Scale | -3.7 score on a scale |
Secondary
Optimal Location of Tinnitus Relief
Location on the cochlear promontory where highest perceived benefit from electrical stimulation
Time frame: Immediately after electrical stimulation procedure (approximately 1 min after stimulation)
Population: No participants were measured and analyzed for this outcome measure because the principal investigator decided to only use one standard location on the promontory during the study for all participants.
Secondary
Tactile Feedback
The number of subjects that reported feeling the electrical stimulus (if at all)
Time frame: Immediately after electrical stimulation procedure (approximately 1 min after stimulation)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Testing Arm | Tactile Feedback | 22 Participants |