Multifocal Tomographic Neurofeedback for Treating Chronic Tinnitus in Older People
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Change from Baseline in Tinnitus symptoms assessed by questionnaires
研究概览
简要总结
Prevalence of chronic subjective tinnitus is rising with age and associated with maladaptive oscillatory changes in auditory as well as non-auditory regions of the brain such as the insula and the anterior cingulate cortex which are known to be key points within the salience and distress networks of the brain.Thus, we are conducting a clinical trial by implementing those auditory as well as non-auditory regions into a tomographical neurofeedback Training (ToNF) -protocol.
Prior to 12 electroencephalography (EEG) -based ToNF-trainings with 36 older participants using standardized Low Resolution Electromagnetic Tomography Software (sLORETA, Pascual-Marqui 2002), participants' brains will be measured using structural magnet resonance imaging (sMRI) in order to identify potential structural markers for training success (e.g. cortical thickness).
Training success will be measured by oscillatory change via EEG before and after the training period as well as by means of follow-up measures. Furthermore, a comprehensive battery of behavioral and psychometric standardized self-report questionnaires will be applied.
Based on this multifocal (Insula, dorsal anterior cingulate cortex & auditory cortex) ToNF we expect oscillatory changes resulting in decreased tinnitus symptoms such as perceived loudness and distress.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic tinnitus (>6 months)
- •Age 40 to 80
- •Informed Consent
- •Fluent in German language
- •mentally & physically fit
排除标准
- •ferromagnetic implants
- •cochlear implants
- •average hearing loss over 50 dB
- •claustrophoby
- •addiction to alcohol or drugs
- •intake of anesthetics, tranquilizers, neuroleptics or antiepileptics
- •acute suicidal
结局指标
主要结局
Change from Baseline in Tinnitus symptoms assessed by questionnaires
时间窗: Time Frame: at 1, 3, 6 month follow up
Assessement of the Tinnitus symptoms before and after the Treatment with neurofeedback by different questionnaires
Change from Baseline in frequency band EEG-activity in the auditory cortex, insula & dorsal anterior cingulate cortex
时间窗: Time Frame: 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
- brain structure (volume, surface area) of the three regions of interest as predictor for training success.(Baseline (measurement before training))