A Monocentric Study for Development and Use of Tomographic Neurofeedback Protocols for Patients Suffering From Chronic Tinnitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Change from Baseline in Tinnitus symptoms assessed by questionnaires
研究概览
简要总结
Chronic tinnitus affects about 10-15% of the population in industrialized countries. Investigations of the brain activity by using electroencephalography (EEG) showed that in localized regions of the hearing system brain activity was decreased. This reduction of activity is thought to be one of the reasons that keep the perception of the tinnitus going. Recent studies have shown that neurofeedback is a viable option for treatment of chronic tinnitus. By using neurofeedback it is possible to train brain functions by the simple principle of rewarding wanted changes and punishing unwanted ones. The purpose of the investigators study is to show the efficacy of specific localized neurofeedback training in comparison to global relaxing neurofeedback training. In order to achieve decreased tinnitus symptoms or even disappearance of the tinnitus, 15 neurofeedback trainings are planned. Before and up to 6 month after the training EEG-recordings are performed.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75
- •Chronic Tinnitus > 0.5 years
- •Informed Consent
- •Fluent in German language
排除标准
- •Psychological and neurological disorders other than tinnitus
- •Drug- or Alcohol abuse
- •Tranquilizer, antiepileptic drugs, antipsychotics or anesthetics intake
- •Impairing hearing loss or Cochlea Implant
研究组 & 干预措施
Tomographic Neurofeedback (TONF)
15x Neurofeedback Trainings, 1-2 times per week
干预措施: Tomographic Neurofeedback (Device)
Non Tomographic Neurofeedback (NTE)
15x Neurofeedback Trainings, 1-2 times per week
干预措施: Non Tomographic Neurofeedback (Device)
结局指标
主要结局
Change from Baseline in Tinnitus symptoms assessed by questionnaires
时间窗: at 1, 3, 6 month follow up
Assessement of the Tinnitus symptoms before and after the Treatment with neurofeedback by different questionnaires tailored for Tinnitus and Quality of life.
Change from Baseline in delta (3-4Hz) and alpha (8-12Hz) frequency band EEG-activity in the auditory cortex
时间窗: at 1, 3, 6 month follow up
EEG recordings of the trained frequency bands are compared before and after the Intervention in the named time periods
次要结局
- Difference in efficacy between Tomographic Neurofeedback (TONF) and Non Tomographic Neurofeedback (NTE) in treatment of tinnitus assessed by tinnitus questionnaires and frequency band EEG-activity measurements (3-4Hz and 8-12Hz) compared to Baseline.(at 1, 3, 6 month follow up)