Cohort Study on Biomarkers and Clinical Treatment of Tinnitus
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- THI
研究概览
简要总结
The goal of this clinical trial is to search for biomarkers in tinnitus patients in tinnitus patients and changes in biomarkers before and after treatment. The main questions it aims to answer are:
- What are the biomarkers of tinnitus patients？
- How do these biomarkers change during treatment and is there a good correlation with behavioral outcomes? Participants will be asked to complete audiological examination, tinnitus assessment, and magnetoencephalography examination, and they will receive sound therapy or repetitive transcranial magnetic stimulation therapy.
详细描述
This study aims to use magnetoencephalography (MEG) to collect the resting state responses before and after treatment in the control group, tinnitus patients in the acoustic stimulation treatment group, and rTMS treatment group. Firstly, compare the differences in power spectrum and brain functional connectivity indicators between tinnitus patients and normal control groups in different frequency bands, providing a theoretical basis for clinical diagnosis, precise positioning of tinnitus damaged areas, and understanding the pathogenesis of tinnitus; Secondly, compare the electrophysiological functional indicators of tinnitus patients before and after treatment to reveal whether the damaged brain network can gradually reshape after treatment, and whether network information can serve as potential biomarkers to indicate the degree of tinnitus recovery; Finally, compare the effectiveness differences between the two treatment methods, analyze their influencing factors, and provide guidance for frequency band precise intervention and rehabilitation of chronic tinnitus patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjective tinnitus lasting for more than 6 months, with a score of>36 of the Tinnitus Disability Inventory (THI)；
- •The otoscopy examination showed that the ear canal and eardrum were normal, and the tympanic impedance maps of both ears were Type A, indicating that language ability met the requirements of language testing
排除标准
- •Family or congenital deafness history, ototoxicity drug use history, otitis media patients, etc
- •Suffering from major physical diseases (sensory and motor disorders, neurological disorders, brain injuries, and other organic diseases) or mental disorders
- •The patient has aggressive behavior and an impulse to damage the device
- •Metal in the body (including orthodontics, dental implants), tattoos, and heart stent surgery
- •Having claustrophobia
- •Contraindications to magnetic resonance examination
结局指标
主要结局
THI
时间窗: follow-up for 1 month after treatment completion
the scores of tinnitus handicap inventory（0-100）
VAS
时间窗: follow-up for 1 month after treatment completion
Visual Analog Scale (VAS) is used to evaluate the loudness of tinnitus. The score range is 0-10
次要结局
未报告次要终点
研究者
Zhiwu Huang, Ph.D.
Professor, PHD, Director of the Hearing Center
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University