Implantation of an Auditory Brainstem Implant for Unilateral Tinnitus Treatment
Implantation of an Auditory Brainstem Implant for the Treatment of Incapacitating Unilateral Tinnitus
This study is testing whether an auditory brainstem implant can help people with severe ringing in one ear feel better by reducing their tinnitus symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Medical Center Groningen Academic / other |
| Locations | 1 site (Groningen) |
| Trial ID | NCT02630589 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of an auditory brainstem implant (ABI) to treat patients suffering from severely invalidating unilateral tinnitus. The ABI is designed to restore hearing in individuals with dysfunction of the cochlear nerve and has shown a side effect of tinnitus reduction in previous cases. The study aims to evaluate the efficacy and safety of the ABI specifically for tinnitus suppression, as this is the first time it is being used primarily for this purpose. Participants will undergo the implantation procedure and be monitored for outcomes related to their tinnitus symptoms.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with unilateral, severely invalidating tinnitus that has not responded to conventional treatments.
Not a fit: Patients with detectable causes for their tinnitus or those who do not meet the specific audiometric criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide significant relief for patients suffering from debilitating tinnitus, improving their quality of life.
How similar studies have performed: While the use of ABI for tinnitus is novel, similar approaches with cochlear implants have shown promising results in reducing tinnitus symptoms.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Unilateral tinnitus * Severely invalidating tinnitus * Men or women, age \>18yr * Tinnitus that is present \>1 years and was stable during the last year * Tinnitus that is nonresponsive to indicated conventional existing treatments (hearing aids and cognitive behavioral therapy (CBT)). If a psychologist has indicated that CBT may ameliorate tinnitus complaints, the patient should have tried CBT for long enough time to reasonably argue that these treatments were not successful. This is the same for hearing aids. * Ipsilateral ear: pure tone audiometry (PTA) thresholds \>40dB and \<90dB (mean over 1-2-4kHz) * Functional hearing in the contralateral ear with pure tone audiometry thresholds \<35dB (mean over 1-2-4 kHz) and with a minimum Δ25dB compared to the ipsilateral ear. * Informed consent after extensive oral and written information about the surgery, complications and the uncertain effect of the ABI on tinnitus Exclusion Criteria: * Detectable cause for tinnitus that requires causal therapy (e.g. vestibular schwannoma, glomus tumor, otosclerosis, arteriovenous malformation) as investigated by radiological and otological examination * Psychiatric pathology and/or an unstable psychological situation as declared by a psychiatrist * Unrealistic expectations as declared by the investigator and/or psychiatrist * Life expectancy \<5 years * History of blood coagulation pathology * ASA \>II * Pregnancy * Anatomic abnormalities that would prevent appropriate placement of the stimulator housing in the bone of the skull * Anatomical abnormalities or surgical complications that might prevent placement of the Auditory Brainstem Implant Active Electrode Array * Known intolerance to the materials used in the implant (medical grade silicone, platinum, iridium and parylene C)
Where this trial is running
Groningen
- University Medical Center Groningen — Groningen, Netherlands (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.