Advanced Neurofeedback for Tinnitus Applying Representational EEG Signatures
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 24
- 主要终点
- Behavioral - Minimal Masking Level
研究概览
简要总结
This study investigates neurofeedback as a potential treatment for chronic tinnitus. Neurofeedback is a non-invasive method that aims to regulate brain activity and may help reduce tinnitus symptoms and the distress associated with them. The purpose of the study is to evaluate the effectiveness, safety, and tolerability of this treatment.
The study duration is approximately nine months, including follow-up assessments. Participants attend 25 study visits, consisting of 20 neurofeedback treatment sessions and 5 assessment appointments. The study follows a randomized, placebo-controlled crossover design, meaning all participants receive both active neurofeedback and placebo neurofeedback in different sequences. The placebo provides feedback that is not based on real-time brain activity and serves as a control to ensure reliable scientific results.
Direct personal benefits cannot be guaranteed; however, participation may contribute to improved understanding and future treatment of tinnitus. A reduction in tinnitus symptoms is possible.
Neurofeedback is an established and safe, non-invasive technique. The specific method examined in this study is newly developed and has not yet been tested. Although no significant side effects are currently known, unforeseen risks cannot be entirely excluded. Overall, the study is classified as a low-risk clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy female or male or diverse patients 18 years to 65 years of age
- •Persistent chronic, subjective tinnitus with duration of more than 3 months
- •Signed informed consent after being informed about the study
- •Fluent in German
- •Tinnitus with a THI Grade 2 to 4 (18-76 points), moderate to severe
- •Willing and able to attend all study visits
排除标准
- •Hyperacusis
- •Concurrent neurological or psychiatric disorders
- •Regular intake of medication influencing the central nervous system (e.g. neuroleptics, hypnotics, sedatives, and anti-epileptics)
- •Somatic tinnitus
- •Asymmetrical hearing (more than 20dB side difference), pantonal hearing loss > 40dB in any measured frequency up to 2kHz
- •Women who are pregnant and/or breast feeding
- •Intention to become pregnant during the course of the study
- •Known or suspected drug or alcohol abuse
- •Participation in another study with investigational drug within the 30 days preceding and during the present study,
- •Enrolment of the investigator, his/her family members, employees and other dependent persons
研究组 & 干预措施
Sham NFB - Real NFB
Cross-Over Design, starting with sham neurofeedback followed by real neurofeedback
干预措施: Neurofeedback (Other)
Real NFB - Sham NFB
Cross-Over Design, starting with real neurofeedback followed by sham neurofeedback
干预措施: Neurofeedback (Other)
结局指标
主要结局
Behavioral - Minimal Masking Level
时间窗: Difference between Baseline (day 0) and: - after treatment block 1(day 29) - after wash-out period 1 and before treatment block 2 (day 113) - after treatment block 2 (day 143) - after wash-out period 2 (day 227)
Changes in tinnitus intensity measured with audiometric testing: \- MML (Minimal Masking Level) in dB SL
Behavioral - Numeric Rating Scale
时间窗: Difference between Baseline (day 0) and: - after treatment block 1(day 29) - after wash-out period 1 and before treatment block 2 (day 113) - after treatment block 2 (day 143) - after wash-out period 2 (day 227)
Changes of tinnitus intensity and distress measured with questionnaires: \- NRS (Numeric Rating Scale) on a 11- point Likert scale from 0 to 10
Behavioral - Tinnitus Functional Index
时间窗: Difference between Baseline (day 0) and: - after treatment block 1(day 29) - after wash-out period 1 and before treatment block 2 (day 113) - after treatment block 2 (day 143) - after wash-out period 2 (day 227)
Changes of tinnitus intensity and distress measured with questionnaires: \- TFI (Tinnitus Functional Index) with a score between 0 and 100
Behavioral - Tinntitus Handicap Inventory
时间窗: Difference between Baseline (day 0) and: - after treatment block 1(day 29) - after wash-out period 1 and before treatment block 2 (day 113) - after treatment block 2 (day 143) - after wash-out period 2 (day 227)
Changes of tinnitus intensity and distress measured with questionnaires: \- THI (Tinntitus Handicap Inventory) with a score between 0 and 100
次要结局
- Neurophysiological - neural features(Difference between Baseline (day 0) and: - after treatment block 1(day 29) - after wash-out period 1 and before treatment block 2 (day 113) - after treatment block 2 (day 143) - after wash-out period 2 (day 227))
- Neurophysiological - Correlation between the behavioral changes and neurophysiological changes.(Difference between Baseline (day 0) and: - after treatment block 1(day 29) - after wash-out period 1 and before treatment block 2 (day 113) - after treatment block 2 (day 143) - after wash-out period 2 (day 227))