A Feasibility Study to Assess the Effectiveness of Different Modalities of Repetitive Transcranial Magnetic Stimulation in the Treatment of Tinnitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Improvement in tinnitus severity following treatment with rTMS
研究概览
简要总结
Tinnitus is a common problem which can have a severe impact on quality of life and for which there is no truly successful treatment available.
Repetitive transcranial magnetic stimulation (rTMS) is a method of stimulating the brain through the application of a magnetic field in a series of rapid pulses and may be a valuable treatment for patients with tinnitus.
The overall aim of this research is to see if patients with tinnitus benefit from treatment with rTMS, and in particular whether one type (continuous theta burst) is more effective than other variations of rTMS. Prior to developing a definitive study to address this area a feasibility study needs to be performed.
The proposed feasibility study aims to determine outcomes necessary to enable development of a definitive study in the future.
40 patients suffering with idiopathic tinnitus will be randomised into 2 groups, a control group receiving a sham treatment, and an active treatment group receiving theta-burst rTMS on 5 consecutive days.
详细描述
Tinnitus is a common problem and can have a severe impact on quality of life. At present there is no truly successful treatment available. Repetitive transcranial magnetic stimulation (rTMS) is a method of stimulating the brain through the application of a magnetic field in a series of rapid pulses. Applying it to the areas of the brain thought to be responsible for tinnitus may offer a valuable treatment for patients.
The overall aim of this research is to see if patients with tinnitus benefit from treatment with rTMS, and in particular whether one type (continuous theta burst) is more effective than other variations of rTMS. Prior to developing a definitive study to address this area a feasibility study needs to be performed.
The proposed feasibility study aims to determine outcomes necessary to enable development of a definitive study in the future. Particularly to ensure adequate recruitment will be possible and to confirm the acceptability of the study design to participants. We will assess the success of our chosen placebo intervention and blinding method. The variance in change in tinnitus level following treatment will enable a sample size calculation to be performed for use in future studies.
40 patients suffering with idiopathic tinnitus will be randomised into 2 groups, a control group receiving a sham treatment, and an active treatment group receiving theta-burst rTMS on 5 consecutive days. The effect of treatment will be assessed through the use of the Tinnitus Functional Index an existing validated tinnitus questionnaire. Feasibility outcomes will be assessed through monitoring retention and recruitment rates and the use of questionnaires related to feasibility outcomes
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years
- •Persistent unilateral or bilateral subjective tinnitus
排除标准
- •Severe or profound hearing loss
- •Patients taking vestibular sedatives, antipsychotic, anxiolytic, antiepileptic and ototoxic medications.
- •Ear infections or discharge
- •History of ear surgery
- •History of noise trauma
- •Excess alcohol consumption
- •Meniere's disease
- •VIII nerve tumour
- •Bells palsy
- •Ramsay-Hunt Syndrome
- •Post-meningitis hearing loss and tinnitus
- •Active psychiatric conditions
- •Congenital or syndromal associations
研究组 & 干预措施
theta-burst rTMS
Active treatment will consist of sessions of continuous theta-burst rTMS on consecutive days for 5 days. This will be delivered with a circular coil to the temporal scalp region overlying the auditory cortex, contralateral to the symptomatic side in unilateral tinnitus and to the left side in bilateral tinnitus. The treatment protocol will consist of treatment at 80% of individual motor threshold (established at the first treatment session) for 600 pulses of 40 seconds duration, which will be repeated after 15 minutes. Each patient will receive 1200 pulses per day.
干预措施: rTMS (Device)
Control arm
The control (sham) stimulation will consist of stimulating with the rTMS coil held at right angles to the participants' head. This will result in no active stimulation of brain tissue but would feel similar to the patient. Each treatment session will therefore last approximately 20 minutes.
干预措施: rTMS (Device)
结局指标
主要结局
Improvement in tinnitus severity following treatment with rTMS
时间窗: 3 months
The primary outcome measure for the definitive trial is the improvement in tinnitus severity following treatment with theta burst rTMS compared to control as demonstrated by change in Tinnitus Functional Index (TFI) scores. Assessed on completion of treatment and at 1 week and 1 month following.
次要结局
- The number of patients willing to complete the trial(3 months)
- Confirm acceptability of trial design to participants(3 months)
- Determine success of sham intervention(3 months)
- Success of assessment methods(3 months)
- Sample size calculation(3 months)