Peripheral-central Correlation Study on the Treatment of Chronic Tinnitus With "Dao qi Tong Luo" Based on the Theory of "Connecting the Two Ears to the Brain"
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Tinnitus Handicap Inventory (THI)
研究概览
简要总结
By comparing the clinical manifestations, ABR parameters and cerebral cortex blood oxygen levels of chronic tinnitus patients and healthy subjects under two different body states, the peripheral-central correlation of chronic tinnitus patients was explored, and the modern scientific significance of the theory of "two ears connecting the brain" was initially expounded. On this basis, the immediate and cumulative effects and peripheral-central correlation of "dao qi tong luo" intervention in chronic tinnitus were observed, and the effective mechanism of "dao qi tong luo" treatment was explored.
详细描述
The study will enroll 15 healthy subjects and 72 subjects with chronic tinnitus. Functional near infrared spectroscopy (fNIRS) will be used to examine specific brain regions, and ABR techniques will record auditory brainstem responses in chronic tinnitus patients and healthy subjects. Lateral comparison was made between chronic tinnitus patients and healthy subjects on the parameters of auditory brainstem response and the level of oxygen outside the cerebral cortex, and the data of the two were integrated to conduct correlation analysis and correlation analysis with clinical manifestations, so as to compare the correlation between peripheral and central auditory function in different body states. Subsequently, the chronic tinnitus subjects will undergo a course of acupuncture treatment. At the end of acupuncture and moxibustion treatment, the immediate and cumulative effects and peripheral - central correlation of "dao qi tong luo" intervention in chronic tinnitus were observed, and the effective mechanism of "dao qi tong luo" treatment was explored.
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
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria for patients with chronic tinnitus
- •Chronic tinnitus patients, that is, the course of disease ≥6 months;
- •No contraindications of fNIRS scanning;
- •The age of 20 years ≤55 years old, gender is not limited, right-handed;
- •The external ear canal is unobstructed and the eardrum is intact
- •The average hearing threshold of both ears is <35dB;
- •Normal expression and understanding ability. Inclusion criteria for healthy subjects
- •No tinnitus, no hearing disorders and other ear diseases;
- •Good health condition, no history of mental disease and nervous system disease;
- •No contraindications of fNIRS scanning;
- •The age of 20 years ≤55 years old, gender is not limited, right-handed;
- •The external ear canal is unobstructed, and the tympanic membrane is complete;
- •Normal expression and understanding ability.
排除标准
- •1.A history of drug dependence or alcohol addiction; 2.Serious central system diseases or other systemic diseases such as cardiovascular and cerebrovascular diseases;
- •Patients with organic diseases such as craniocerebral trauma;
- •Sudden deafness, Meniere's disease, otosclerosis, acoustic neuroma and other inner ear or auditory nerve diseases; 5.External otitis, acute/chronic otitis media and other external ear middle-ear related diseases;
- •Patients with auditory hypersensitivity;
- •Pregnancy, preparation for pregnancy, breastfeeding population;
- •There are metal implants in the body, fNIRS detection contraindicated.
结局指标
主要结局
Tinnitus Handicap Inventory (THI)
时间窗: at baseline (pre-treatment),procedure
Tinnitus Handicap Inventory is based on relevant expert consensus. THI scores range from 0 to 100, with the higher the score, the more severe the condition
次要结局
- Auditory Brainstem Response (ABR)(at baseline (pre-treatment), procedure)
- Functional Near-Infrared Spectroscopy (Fnirs)(at baseline (pre-treatment), procedure)
- Tinnitus Evaluation Questionnaire (TEQ)(at baseline (pre-treatment), procedure)
研究者
Jie Zhou
Principal Investigator
The Third Affiliated hospital of Zhejiang Chinese Medical University