Implantation of an Auditory Brainstem Implant for the Treatment of Incapacitating Unilateral Tinnitus
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Tinnitus Functioning Index (TFI)
研究概览
简要总结
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.
详细描述
Rationale: 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.
Objective. To evaluate the efficacy of an ABI for the suppression of unilateral, intractable tinnitus and to establish the safety of the ABI for this new indication.
Study design. This is a single center, non-randomized, prospective cohort, intervention pilot study. There is no control group. In this study, 10 patients will be implanted with an ABI.
Study population. Adult patients with invalidating, unilateral, intractable tinnitus and ipsilateral severe hearing loss are included in this study. All study participants have no significant comorbidity and are mentally competent.
Intervention. All study participants receive an ABI, which will be neurosurgically implanted. The ABI will be switched on 6 weeks after implantation. The surgery and post-surgery follow-up and switch-on procedures are consistent with the intended use of the ABI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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)
结局指标
主要结局
Tinnitus Functioning Index (TFI)
时间窗: pre-op, 3 months, 6 months, 1, 2,3,4,5 year postoperative
Unit of measure: Items on a scale. The TFI (tinnitus functioning index) is a questionnaire validated to detect changes in tinnitus outcome after an intervention
次要结局
- ABI-related outcomes(at every change in ABI setting (minimum: switch on, 6 wk after switch on, 3 months, 6 months, 1, 2,3,4,5 year postoperative)
- Pure tone audiometry(pre-op, 3 months, 6 months, 1, 2,3,4,5 year postoperative)
- Tinnitus Handicap Inventory (THI)(pre-op, 3 months, 6 months, 1, 2,3,4,5 year postoperative)
- Vestibular test(pre-op, 3 months postoperative)
- Hospital anxiety and depression scale (HADS)(pre-op, 3 months, 6 months, 1, 2,3,4,5 year postoperative)
- Tinnitus analysis(pre-op, 3 months, 6 months, 1, 2,3,4,5 year postoperative)
- Visual Analogue Score (VAS)(pre-op, 3 months, 6 months, 1, 2,3,4,5 year postoperative)
研究者
Minke van den Berge
prof. P. van Dijk
University Medical Center Groningen