An auditory brainstem implant for treatment of unilateral tinnitus: protocol for an interventional pilot study
| Autor: | Pim van Dijk, J M C van Dijk, Minke J C van den Berge, Rolien Free, Jan D M Metzemaekers, Bert Maat |
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| Přispěvatelé: | Perceptual and Cognitive Neuroscience (PCN), Movement Disorder (MD) |
| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
medicine.medical_specialty
Visual analogue scale medicine.medical_treatment auditory brainstem implant Audiology Hospital Anxiety and Depression Scale Neurotology 03 medical and health sciences 0302 clinical medicine Quality of life Cochlear implant medicine otorhinolaryngologic diseases Protocol tinnitus 030223 otorhinolaryngology Ear Nose and Throat/Otolaryngology business.industry General Medicine Institutional review board 3. Good health neurotology neuromodulation medicine.symptom business 030217 neurology & neurosurgery Tinnitus Auditory brainstem implant |
| Zdroj: | BMJ Open BMJ Open, 9(6):e026185. BMJ PUBLISHING GROUP |
| ISSN: | 2044-6055 |
| Popis: | IntroductionTinnitus 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 analysisIn 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 disseminationThe 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 atwww.clinicialtrials.govand will be updated if amendments are made. Results of this study will be disseminated in peer-reviewed journals and at scientific conferences.Trial registration numberNCT02630589.Trial statusInclusion 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. |
| Databáze: | OpenAIRE |
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