Cochlear Promontory Stimulation for Treatment of Tinnitus
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Other Indications |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/2/2018 |
| Start Date: | November 22, 2017 |
| End Date: | December 31, 2019 |
Cochlear Promontory Stimulation for Treatment of Tinnitus: Towards Developing an Implantable Device
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.
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.
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
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
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 greater than 75%
2. Asymmetric 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. 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 3 years
2. History of brain or major ear surgery
3. Prior major head trauma
4. History of depression or anxiety
1. 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)
2. Inability to assess, continue or complete trial
5. Currently on antidepressants, anxiolytics or antipsychotics
6. Active use of other tinnitus treatments
7. MRI Incompatible Devices
8. Known pregnancy
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