Effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment in Patients With Chronic Tinnitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- UMC Utrecht
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Tinnitus severity with the Tinnitus Questionnaire
研究概览
简要总结
Tinnitus is a phantom auditory perception of meaningless sound, meaning that there is registration of sound in the absence of an external or internal acoustic stimulus. It is a common problem (prevalence 7-19%) which may interfere with the ability to lead a normal life. Unfortunately, it is a very difficult symptom to treat because there are hardly any therapeutic options for the cause of tinnitus. Most therapies focus on alleviating the condition rather than treating the cause. Tinnitus is thought to be generated in the brain, as a result of functional reorganization of auditory neural pathways and tonotopic maps in the central auditory system, following damage to the peripheral auditory system. Repetitive Transcranial magnetic stimulation (rTMS) is a therapy, based on this concept of reorganization in the auditory cortex. It uses a pulsed magnetic field to disrupt the neural circuit and to thereby (temporarily) excite or inhibit certain brain areas, leading to the suppression of tinnitus.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •Chronic, non fluctuating, tinnitus, demonstrated by means of the diagnostic Protocol Tinnitus UMCU, of at least two months duration.
- •Age ≥18 years
- •Dutch speaking
排除标准
- •Treatable cause of the tinnitus
- •Use of anticonvulsant medication or other psychotherapeutic drugs
- •History of epilepsy or family members with epilepsy
- •Presence of active migraine
- •Presence of psychiatric, severe internal or heart diseases or other neurologic diseases besides epilepsy
- •Metal objects in and around body that can not be removed
- •Pregnancy (will be tested on the first day of rTMS using a urine pregnancy test)
- •Alcohol or drug abuse
- •Prior treatment with TMS
结局指标
主要结局
Tinnitus severity with the Tinnitus Questionnaire
时间窗: after treatment, 1 week, 1, 3 and 6 months
次要结局
- Tinnitus Handicap Inventory(after treatment, 1 week, 1, 3 and 6 months)
- Beck Depression Inventory(after treatment, 1 week, 1, 3 and 6 months)
- State Trait Anxiety Index(after treatment, 1 week, 1, 3 and 6 months)
- Visual Analog Scales on burden, loudness, pitch, presence, and variability of tinnitus and specific problems.(for the first three months daily and for the second three months monthly)
- Audiometry and tinnitus analysis (character match, pitch match, loudness match, minimal masking level, residual inhibition)(1 week after treatment and after 3 and 6 months)