Neural and Clinical Effects of 40 Hz Burst Stimulation in Tinnitus: a Four-phase Self-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 265
- 试验地点
- 1
- 主要终点
- Tinnitus suppression strength
研究概览
简要总结
Tinnitus affects 10-15% of adults and is frequently associated with impaired quality of life, anxiety, and sleep disturbance. Conventional sound therapies based on continuous masking provide inconsistent and short-lived relief, and the neural mechanisms underlying residual inhibition (RI) remain unclear.
This study aims to determine whether 40 Hz burst stimulation with high-frequency carriers can achieve longer-lasting RI than continuous sound, and to explore its underlying neural mechanisms using EEG.
详细描述
Residual inhibition (RI) refers to the temporary reduction or disappearance of tinnitus following sound stimulation and provides an important clue for identifying patients who may benefit from acoustic therapy. However, the effects of different sound stimulation strategies on RI remain poorly understood.
This study evaluates whether 40 Hz burst-modulated sound achieves stronger and longer RI compared with conventional continuous stimulation. The trial follows a four-phase design:
Phase 1: Exploratory testing of burst versus continuous tones at different frequencies.
Phase 2: Large-scale validation in 265 patients. Phase 3: Development of a personalized stimulation protocol using adaptive spectral optimization.
Phase 4: EEG investigation of neural mechanisms, focusing on gamma oscillations and functional connectivity changes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with subjective tinnitus;
- •Chronic tinnitus: tinnitus course ≥ 1 month;
- •Normal middle ear function;
- •The average hearing threshold (defined as mean of 0.5, 1, 2, and 4 kHz) of the unaffected ear < 60 dB;
- •Tinnitus can be heard under normal circumstances.
- •Subjects are able to understand the purpose of the study, volunteer to participate and cooperate with the instructors to complete the experiment, and be willing to sign the informed consent.
排除标准
- •Acute phase tinnitus;
- •Fluctuating tinnitus loudness;
- •Severe psychiatric disorders;
- •Inability to complete tinnitus testing;
- •Fluctuating or retrocochlear hearing loss;
- •Conductive hearing loss;
- •Currently participating in other research projects that may affect tinnitus;
- •Subjects who are not considered suitable for this clinical trial by the researchers.
结局指标
主要结局
Tinnitus suppression strength
时间窗: Immediately after the sound stimulation session.
Residual inhibition depth, 0-100% reduction
Residual inhibition duration
时间窗: Immediately after the sound stimulation session.
Time in seconds until tinnitus returns to baseline after stimulation
次要结局
- EEG spectral power changes(measured across the entire 10-minute EEG recording session (baseline, during stimulation, and post-stimulation))
- EEG functional connectivity changes(measured across the entire 10-minute EEG recording session (baseline, during stimulation, and post-stimulation))