Clinical Trials

https://clinicaltrials.gov/ct2/show/NCT02630589

Implantation of an Auditory Brainstem Implant for the Treatment of Incapacitating Unilateral Tinnitus

Implantation of an Auditory Brainstem Implant for the Treatment of Incapacitating Unilateral Tinnitus
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ClinicalTrials.gov Identifier: NCT02630589
Recruitment Status : Recruiting
First Posted : December 15, 2015
Last Update Posted : May 2, 2018
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Sponsor:
University Medical Center Groningen
Collaborator:
Med-El Elektromedizinische Geraete GmbH
Information provided by (Responsible Party):
Minke van den Berge, University Medical Center Groningen

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Study Description
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Brief Summary:
Tinnitus is the perception of sound or noise in the absence of an external physical source. It is a highly prevalent condition and for a high percentage of patients, there is no satisfying treatment modality. For some people, tinnitus has a very severe impact on quality of life, leading to incapacity for work and sometimes even suicidality. The auditory brainstem implant (ABI) is an implant indicated for the restoration of hearing in patients with an hypo-, or aplasia of the cochlear nerve or with dysfunction of the nerve caused by tumor growth in neurofibromatosis type II. It has been shown that the standard intended effect of an ABI has reduction of tinnitus as a welcome side effect in about 66% of the cases. This is in analogy with the promising effect of a cochlear implant (CI) as a treatment for patients with unilateral tinnitus. In this study, the effect of an ABI on severely invalidating, unilateral, intractable tinnitus will be investigated. The ABI may have an advantage over the CI as tinnitus treatment, because CI-implantation leads to destruction of inner ear structures, leading to profound deafness, while an ABI is presumed to not damage anatomical structures. This is the first study to implant an ABI for the primary aim of tinnitus reduction in an intervention pilot study. In total 10 patients with unilateral, intractable tinnitus and severe hearing loss in the ipsilateral ear, will be implanted with the ABI.

Condition or disease Intervention/treatment Phase
Tinnitus
Device: Auditory brainstem implant
Not Applicable

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Study Design
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Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Implantation of an Auditory Brainstem Implant for the Treatment of Incapacitating Unilateral Tinnitus
Study Start Date : July 2016
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2024
Resource links provided by the National Library of Medicine
MedlinePlus related topics: Tinnitus
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: ABI implantation
All 10 patients included in the study will be neurosurgically implanted with the ABI. This is open label, not blinded. The implant is permanent, but can be switched off.
Device: Auditory brainstem implant
The ABI will be implanted by the neurosurgeon. The implant is fixed in a bed drilled in the parietal-temporal cortex, and the ABI electrode array is inserted into the lateral recess of the fourth ventricle and placed on the cochlear nucleus. Access to the cochlear nucleus will be made via retrosigmoid transcranial approach.
Other Name: ABI