Cochlear Promontory Stimulation for Treatment of Tinnitus

Tinnitus Clinical Trial

Official title:

Cochlear Promontory Stimulation for Treatment of Tinnitus: Towards Developing an Implantable Device

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03759834
• Other study ID #: 17-004832
• Status: Suspended
• Phase: N/A
• Start date: January 4, 2018
• Est. completion date: June 2024

Study information

• Verified date: July 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 21
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tinnitus

Intervention

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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

References & Publications (12)

Arts RA, George EL, Chenault MN, Stokroos RJ. Optimizing intracochlear electrical stimulation to suppress tinnitus. Ear Hear. 2015 Jan;36(1):125-35. doi: 10.1097/AUD.0000000000000090. — View Citation

Arts RA, George EL, Stokroos RJ, Vermeire K. Review: cochlear implants as a treatment of tinnitus in single-sided deafness. Curr Opin Otolaryngol Head Neck Surg. 2012 Oct;20(5):398-403. doi: 10.1097/MOO.0b013e3283577b66. — View Citation

Mertens G, De Bodt M, Van de Heyning P. Cochlear implantation as a long-term treatment for ipsilateral incapacitating tinnitus in subjects with unilateral hearing loss up to 10 years. Hear Res. 2016 Jan;331:1-6. doi: 10.1016/j.heares.2015.09.016. Epub 2015 Oct 24. — View Citation

Perez R, Shaul C, Vardi M, Muhanna N, Kileny PR, Sichel JY. Multiple electrostimulation treatments to the promontory for tinnitus. Otol Neurotol. 2015 Feb;36(2):366-72. doi: 10.1097/MAO.0000000000000309. — View Citation

Rubinstein JT, Tyler RS, Johnson A, Brown CJ. Electrical suppression of tinnitus with high-rate pulse trains. Otol Neurotol. 2003 May;24(3):478-85. doi: 10.1097/00129492-200305000-00021. — View Citation

Steenerson RL, Cronin GW. Treatment of tinnitus with electrical stimulation. Otolaryngol Head Neck Surg. 1999 Nov;121(5):511-3. doi: 10.1016/S0194-5998(99)70048-3. — View Citation

Topf MC, Hsu DW, Adams DR, Zhan T, Pelosi S, Willcox TO, McGettigan B, Fisher KW. Rate of tympanic membrane perforation after intratympanic steroid injection. Am J Otolaryngol. 2017 Jan-Feb;38(1):21-25. doi: 10.1016/j.amjoto.2016.09.004. Epub 2016 Sep 28. — View Citation

Tsai BS, Sweetow RW, Cheung SW. Audiometric asymmetry and tinnitus laterality. Laryngoscope. 2012 May;122(5):1148-53. doi: 10.1002/lary.23242. Epub 2012 Mar 23. — View Citation

Tunkel DE, Bauer CA, Sun GH, Rosenfeld RM, Chandrasekhar SS, Cunningham ER Jr, Archer SM, Blakley BW, Carter JM, Granieri EC, Henry JA, Hollingsworth D, Khan FA, Mitchell S, Monfared A, Newman CW, Omole FS, Phillips CD, Robinson SK, Taw MB, Tyler RS, Waguespack R, Whamond EJ. Clinical practice guideline: tinnitus. Otolaryngol Head Neck Surg. 2014 Oct;151(2 Suppl):S1-S40. doi: 10.1177/0194599814545325. — View Citation

Tyler RS. Patient preferences and willingness to pay for tinnitus treatments. J Am Acad Audiol. 2012 Feb;23(2):115-25. doi: 10.3766/jaaa.23.2.6. — View Citation

Watanabe K, Okawara D, Baba S, Yagi T. Electrocochleographic analysis of the suppression of tinnitus by electrical promontory stimulation. Audiology. 1997 May-Jun;36(3):147-54. doi: 10.3109/00206099709071968. — View Citation

Zeman F, Koller M, Figueiredo R, Aazevedo A, Rates M, Coelho C, Kleinjung T, de Ridder D, Langguth B, Landgrebe M. Tinnitus handicap inventory for evaluating treatment effects: which changes are clinically relevant? Otolaryngol Head Neck Surg. 2011 Aug;145(2):282-7. doi: 10.1177/0194599811403882. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	7 days after electrical stimulation procedure
Secondary	Optimal Location of Tinnitus Relief	Location on the cochlear promontory where highest perceived benefit from electrical stimulation	Immediately after electrical stimulation procedure (approximately 1 min after stimulation)
Secondary	Auditory Feedback	Perception of hearing the electrical stimulus (if at all)	Immediately after electrical stimulation procedure (approximately 1 min after stimulation)
Secondary	Tactile Feedback	Perception of hearing the electrical stimulus (if at all)	Immediately after electrical stimulation procedure (approximately 1 min after stimulation)
Secondary	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).	7 days after electrical stimulation procedure
Secondary	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 has pre-set marks between the extremes of 0 (no pain) and 10 (unbearable pain).	7 days after electrical stimulation procedure

External Links

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