NL-OMON52782招募中不适用
Deep brain stimulation for refractory tinnitus - DBS for tinnitus
Medisch Universitair Ziekenhuis Maastricht0 个研究点目标入组 6 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •In order to be eligible to participate in this study, a subject must meet all
- •of the following criteria, all by consideration of the multidisciplinary expert
- •group:, • Medically refractory tinnitus. Patient does not respond to available
- •tinnitus treatment and is thoroughly evaluated by the multidisciplinary
- •tinnitus team in MUMC. Available tinnitus treatments are hearing aids (except
- •if hearing is normal) and evidence-based cognitive treatment in Hoensbroek
- •(Cima et al., 2012) or a similar version of this treatment in the MUMC
- •Minimum age 18 years, maximum age 69 years.
- •Experiencing tinnitus which is:
- •o Not pulsatile
- •oUnilateral or bilateral
- •o Severe tinnitus (based on the TQ score >= 47)
- •o Chronic and stable (present > 2 years and stable > 1 year).
- •Bilateral hearing of high tone Fletcher Index < 60 dB
- •Willingness to participate in this study (informed consent)
排除标准
- •Anatomic cause of tinnitus (e.g. vestibular schwannoma, tumour, middle-ear
- •DSM-V psychiatric disorders, other than depression or anxiety disorder (such
- •as bipolar disorder, dementia, addiction, personality disorders); diagnosed by
- •a psychiatrist
- •Depression or anxiety disorder which was already present before tinnitus
- •Cognitive impairment (assessed with standard *cognitive functioning battery
- •test* questionnaires) or coping problems (CISS-21)
- •Active ear diseases that needs further attention according to research team
- •Pregnancy or breast-feeding
- •Active suicide thoughts or attempts
- •Underlying malignancies, whenever life expectancy is lower than 2 years
- •Other exclusion criteria are the same as for the standard DBS operation in
- •clinical care: significant cerebral atrophy, multiple white matter lesions or
- •focal brain anomalies.
- •Contra-indication for Magnetic Resonance Imaging (claustrophobia or implanted
- •metal objects such as cardiac pacemakers, intracardiac lines, implanted
- •medication pumps, implanted electrodes in the brain, other intracranial metal
- •objects with the exception of dental fillings).
- •Also general contra-indications for surgery are considered as exclusion
- •criteria, e.g. coagulopathies, The specialist team can decide on clinical
- •grounds that a patient does or does not qualify for MGB-DBS treatment.
研究者
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