Actively Recruiting
Implantation of an Auditory Brainstem Implant for the Treatment of Incapacitating Unilateral Tinnitus
Led by University Medical Center Groningen · Updated on 2024-02-13
10
Participants Needed
1
Research Sites
600 weeks
Total Duration
On this page
Sponsors
U
University Medical Center Groningen
Lead Sponsor
M
MED-EL Elektromedizinische Geräte GesmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Implantation of an Auditory Brainstem Implant for the Treatment of Incapacitating Unilateral Tinnitus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Unilateral tinnitus
- Severely invalidating tinnitus
- Men or women, age over 18 years
- Tinnitus present for more than 1 year and stable during the last year
- Tinnitus nonresponsive to conventional treatments including hearing aids and cognitive behavioral therapy
- Ipsilateral ear hearing loss with pure tone audiometry thresholds above 40 dB and below 90 dB (mean over 1-2-4 kHz)
- Functional hearing in the contralateral ear with pure tone audiometry thresholds below 35 dB (mean over 1-2-4 kHz) and at least 25 dB better than the ipsilateral ear
- Provided informed consent after detailed explanation of surgery, risks, and uncertain effects
You will not qualify if you...
- Detectable cause for tinnitus requiring causal therapy (e.g., vestibular schwannoma, glomus tumor, otosclerosis, arteriovenous malformation)
- Psychiatric pathology or unstable psychological condition as declared by a psychiatrist
- Unrealistic expectations as declared by investigator or psychiatrist
- Life expectancy less than 5 years
- History of blood coagulation disorders
- American Society of Anesthesiologists (ASA) classification above II
- Pregnancy
- Anatomic abnormalities preventing placement of the stimulator housing in the skull bone
- Anatomical abnormalities or surgical complications preventing placement of the ABI electrode array
- Known intolerance to implant materials (medical grade silicone, platinum, iridium, parylene C)
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Medical Center Groningen
Groningen, Netherlands, 9700RB
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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