Gentamicin Treatment Prior to Vestibular Schwannoma Surgery in Patients With Definite Remaining Vestibular Function
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Differences and changes of postural control following surgery, compared to before surgery
研究概览
简要总结
The purpose of the study is to determine whether vestibular and postural compensation following schwannoma surgery is improved by ablating remaining vestibular function prior to surgery, through gentamicin injections in the middle ear.
详细描述
The residual function of the vestibular system before surgery differs considerably between patients, due to extent and influence of tumor growth, resulting in varying spectra of post-surgery illness as well as vestibular symptoms. An acute unilateral vestibular deafferentation (uVD) (if significant vestibular function remains prior to surgery) invariably results in severe nausea and vertigo. The nausea/vertigo induced by surgery and sudden uVD both can impede vestibular compensation processes and in extension, also the need for rehabilitation. The vestibular PREHAB protocol was developed in order to address this problem and to ensure an enhanced and sufficient rehabilitation. The protocol encompass treating patients that have measurable vestibular function before surgery with intratympanic gentamicin injections, thus producing gradually a uVD over a period of 3-4 weeks, whilst performing daily vestibular exercises before and after the gentamicin treatment. Through this procedure the sensory trauma is separated from the surgical trauma, making it possible for vestibular compensation to ensue as the vestibular function gradually decline from gentamicin toxicity, unencumbered by any depression of central nervous function that might result from schwannoma surgery or the acute stages of an uVD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •diagnosed with vestibular schwannoma and surgical treatment is advised
- •remaining vestibular function
排除标准
- •impaired decision making
- •no remaining vestibular function
- •signs of central nervous dysfunction
- •neurofibromatosis
- •Patients are advised not to participate in the gentamicin arm but encouraged to participate in the 'non-gentamicin' arm:
- •when hearing is better than 30decibel (dB) i pure tone average (500, 1000, 2000, 3000/4000 Hz) and speech discrimination better than 70% -when the neurosurgeon aim at hearing preservation surgery and do not want to risk gentamicin- associated hearing loss
研究组 & 干预措施
Gentamicin treated
Installation of gentamicin in the middle ear 6 weeks prior to surgery + rehabilitation exercises before and after both treatment and surgery.
Rehabilitation exercises are not considered to be an intervention since their benign impact on vestibular/postural compensation is well documented, and exclusion from exercises would not be approved by the ethical board.
干预措施: Gentamicins (Drug)
结局指标
主要结局
Differences and changes of postural control following surgery, compared to before surgery
时间窗: At first vestibular assessment at the time for inclusion and 6 months after surgery
Postural control assessed with posturography during a sensory conflict
次要结局
- Differences of perceived dizziness after surgery(6 months after surgery)
- Differences of changes in levels of perceived dizziness after surgery as compared to before surgery(At first vestibular assessment and 6 months after surgery)
- Differences in vestibular compensation after surgery(6 months after surgery)
- Change of vestibular function after gentamicin treatment(6weeks after gentamicin treatment)
- Differences of duration of hospital stay(After surgery for the duration of the hospital stay up to two weeks)
- Differences of subjective well being after surgery(Immediate time after surgery (2 weeks))
- Change of hearing levels(At first vestibular assessment and 2 weeks after gentamicin installation)
- Change of subjective well being after gentamicin treatment(Immediate time after gentamicin installation (2 weeks))
- Differences in the level of stress after surgery(Daily after surgery for the duration of the hospital stay up to 2 weeks)
- Change of level of perceived dizziness after gentamicin(At first vestibular assessment and 6 weeks after gentamicin installation)
- Differences of level of anxiety and depression(6 months after surgery)
- Occurrence of spontaneous nystagmus after surgery(Day 1 after surgery and for duration of either spontaneous nystagmus or hospital stay (up to 2 weeks))