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Prom Stim

Overview

About this study

The purpose of this study is to characterize the safety and efficacy of cochlear promontory stimulation in the short term relief of tinnitus.  

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 60%

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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 12/14/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Matthew Carlson, M.D.

Closed for enrollment

More information

Publications

  • To determine the rate of persistent tympanic membrane perforation after intratympanic steroid injection. To determine which comorbid conditions and risk factors are associated with prolonged time to perforation closure following intratympanic steroid injection. Read More on PubMed
  • The authors previously demonstrated that tinnitus resulting from unilateral hearing loss (UHL) can be treated with electrical stimulation via a Cochlear Implant (CI). The study aimed to do a long-term (LT) evaluation of CI in subjects suffering from UHL and accompanied incapacitating tinnitus up to 10 years. The primary focus of the study is on LT tinnitus reduction. Read More on PubMed
  • To assess the safety and efficacy of multiple sessions of electrostimulation by a transtympanic needle electrode on the promontory for tinnitus relief. Read More on PubMed
  • Research on tinnitus suppression by intracochlear electrical stimulation has gained interest over the past few decades and it has become easier to apply since the introduction of cochlear implants (CI). This study attempted to gain more insight into optimal stimulation characteristics for tinnitus suppression. Read More on PubMed
  • Tinnitus is the perception of sound without an external source. More than 50 million people in the United States have reported experiencing tinnitus, resulting in an estimated prevalence of 10% to 15% in adults. Despite the high prevalence of tinnitus and its potential significant effect on quality of life, there are no evidence-based, multidisciplinary clinical practice guidelines to assist clinicians with management. The focus of this guideline is on tinnitus that is both bothersome and persistent (lasting 6 months or longer), which often negatively affects the patient's quality of life. The target audience for the guideline is any clinician, including nonphysicians, involved in managing patients with tinnitus. The target patient population is limited to adults (18 years and older) with primary tinnitus that is persistent and bothersome. Read More on PubMed
  • Tinnitus is a symptom that is highly associated with hearing loss. Its incidence is expected to increase due to the detrimental effects of occupational and leisure noise. Even though no standard treatment is currently available, the effect of cochlear implants on tinnitus in single-sided deafness (SSD) is under scientific attention. This review reveals an overview of all publicly available reports about cochlear implant as a treatment for tinnitus in SSD. Read More on PubMed
  • To identify an optimal audiometric asymmetry index for predicting tinnitus laterality. Read More on PubMed
  • There will likely be several different tinnitus treatments necessary, and it is important to understand patient preferences and factors that might contribute to treatment acceptability. This study explores the acceptability of a wide range of different tinnitus treatments, from noninvasive wearable devices to surgically implanted devices in the brain. Understanding how tinnitus sufferers consider and rank such options and how they might be influenced by their own perception of the severity of their tinnitus could help clinicians, researchers, and companies plan future efforts for approaching new treatments. Read More on PubMed
  • To determine the minimum change of the Tinnitus Handicap Inventory (THI) score that could be considered clinically relevant, the authors compared the absolute change of the THI with the Clinical Global Impression–Improvement (CGI-I) score. Read More on PubMed
  • Application of high-rate pulse trains (e.g., 4800 pps) to the cochlea may represent an effective treatment of tinnitus. Read More on PubMed
  • The purpose of this study was to evaluate the treatment of tinnitus with electrical stimulation. Five hundred patients with tinnitus were treated with probe electrical stimulation. Causes of tinnitus were sensorineural hearing loss (303 patients), Meniere's disease (88), infection (25), head trauma (39), acoustic trauma (25), ototoxicity (4), and chemotherapy (2). Treatment involved 6 to 10 transcutaneous treatment electrical stimulation sessions biweekly. Fifty-three percent of patients showed decreases in their tinnitus as measured by a subjective rating scale. With a 3-month follow-up, 72% had no loss of benefit. Thirteen patients had temporary increases in their tinnitus. Two patients had permanent increases. Probe electrical stimulation seems to offer some benefit in about half the patients treated for annoying tinnitus. Read More on PubMed
  • To investigate the origin, and evaluate the mechanism by which tinnitus is suppressed we performed electrical promontory stimulation (EPS) in 56 patients with tinnitus, and measured the compound action potential (CAP) using electrocochleography before and after EPS. In the group of patients in whom tinnitus was suppressed, the CAP amplitudes increased significantly, whereas the latencies showed no remarkable change. In the group of patients in whom tinnitus was not suppressed, both the CAP amplitudes and latencies exhibited no significant change. These data indicate that the effect on the cochlear nerve plays an important role in the suppression of tinnitus by EPS. The CAP reflects the number of the auditory nerve fibers which discharge synchronously. It is speculated that an increase of the CAP amplitudes is caused by synchronizing discharges of the auditory nerve fibers, and that the mechanism by which EPS suppresses tinnitus may be related to synchronizing these discharges. Read More on PubMed

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