An auditory brainstem implant for treatment of unilateral tinnitus: protocol for an interventional pilot study

Minke J C van den Berge, J M C van Dijk, Jan D M Metzemaekers, Bert Maat, Rolien H Free, Pim van Dijk, Minke J C van den Berge, J M C van Dijk, Jan D M Metzemaekers, Bert Maat, Rolien H Free, Pim van Dijk

Abstract

Introduction: Tinnitus may have a very severe impact on the quality of life. Unfortunately, for many patients, a satisfactory treatment modality is lacking. The auditory brainstem implant (ABI) was originally indicated for hearing restoration in patients with non-functional cochlear nerves, for example, in neurofibromatosis type II. In analogy to a cochlear implant (CI), it has been demonstrated that an ABI may reduce tinnitus as a beneficial side effect. For tinnitus treatment, an ABI may have an advantage over a CI, as cochlear implantation can harm inner ear structures due to its invasiveness, while an ABI is presumed to not damage anatomical structures. This is the first study to implant an ABI to investigate its effect on intractable tinnitus.

Methods and analysis: In this pilot study, 10 adults having incapacitating unilateral intractable tinnitus and ipsilateral severe hearing loss will have an ABI implanted. The ABI is switched on 6 weeks after implantation, followed by several fitting sessions aimed at finding an optimal stimulation strategy. The primary outcome will be the change in Tinnitus Functioning Index. Secondary outcomes will be tinnitus burden and quality of life (using Tinnitus Handicap Inventory and Hospital Anxiety and Depression Scale questionnaires), tinnitus characteristics (using Visual Analogue Scale, a tinnitus analysis), safety, audiometric and vestibular function. The end point is set at 1 year after implantation. Follow-up will continue until 5 years after implantation.

Ethics and dissemination: The protocol was reviewed and approved by the Institutional Review Board of the University Medical Centre Groningen, The Netherlands (METc 2015/479). The trial is registered at www.clinicialtrials.gov and will be updated if amendments are made. Results of this study will be disseminated in peer-reviewed journals and at scientific conferences.

Trial registration number: NCT02630589.

Trial status: Inclusion of first patient in November 2017. Data collection is in progress. Trial is open for further inclusion. The trial ends at 5 years after inclusion of the last patient.

Keywords: auditory brainstem implant; neuromodulation; neurotology; tinnitus.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
The auditory brainstem implant consists of several components (from left to right): a remote control; the speech processor (consisting of transducer, microphone and connecting cable) which is the external and visible part of the implant; the receiver-stimulator with electrode (implantable component) and close-up of the electrode paddle.
Figure 2
Figure 2
Overview of the position of the implant and placement of the electrode on the cochlear nucleus on the brainstem. Reproduced with permission of MED-EL.
Figure 3
Figure 3
Study timeline. ABI, auditory brainstem implant; OR, operating room; mo, months; T, time point, wk, weeks; yr, years.

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Source: PubMed

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