The Efficacy of Repetitive Transcranial Magnetic Stimulation in Patients With Chronic Subjective Tinnitus
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Tinnitus Handicap Inventory (THI)
研究概览
简要总结
The aim of this study is to compare the efficacy of frequency-specific patterned repetitive transcranial magnetic stimulation (rTMS) and 1Hz rTMS for the treatment of chronic subjective tinnitus. In this single-blind randomized controlled study, patients will be randomly assigned 1:1 to receive two different types of rTMS stimulation.
详细描述
Tinnitus is a common disorder with a prevalence of 10-25% among adults, which seriously affects the quality of life of patients. Many studies have reported significant efficacy of repetitive transcranial magnetic stimulation (rTMS) for tinnitus, but its optimal stimulation parameters are not clear. Therefore, there is necessary to assess the clinical efficacy and mechanism of different types of rTMS for the treatment of chronic subjective tinnitus through rigorously designed clinical studies.
The study will assess the severity of tinnitus and the mood and sleep status of the patients through several scales and tinnitus psychoacoustic assessment before treatment, after treatment and at follow-up. The primary research hypothesis is that frequency-specific patterned rTMS will be superior to 1Hz rTMS in reducing tinnitus-related 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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged between 18 and 80 years old.
- •Experiencing persistant subjective tinnitus for at least 3 months.
- •A score of 38 or more on THI.
- •50 dB HL or less on the average pure tone threshold (0.5, 1, 2kHz) of the worse ear.
- •Voluntarily participate in the study and sign the informed consent form.
- •Have normal mental status and cognitive function, and be able to cooperate with the research process.
排除标准
- •Diagnosis of Meniere's disease, conductive hearing loss or objective tinnitus.
- •History of epilepsy or stroke.
- •Diagnosis of acoustic neuroma.
- •Severe sensorineural hearing loss.
- •Surgically or traumatically implanted ferromagnetic foreign bodies, including but not limited to pacemakers, neurostimulators, prosthetic metal heart valves, aneurysm clips (non-titanium alloy), intraocular metal foreign bodies, cochlear implants, metal prostheses, metal joints, fixed steel plates or steel pins.
- •Patients with active metal foreign bodies (metal implants, dentures, contraceptive rings), insulin pumps, etc., who have been evaluated in detail and are at risk for rTMS treatment.
- •Patients taking vestibular sedatives, antipsychotics, anxiolytics, antiepileptics, and ototoxic drugs.
- •Patients with a recent history of alcohol or drug abuse
- •Bell's palsy
- •Acute ear infection within the last 1 month
- •Inability to cooperate or complete the study process
- •Participation in another clinical trial within the last month.
- •Have any condition that may affect compliance or safety
- •Any other condition that, in the opinion of the investigator, makes enrollment in the study inappropriate.
结局指标
主要结局
Tinnitus Handicap Inventory (THI)
时间窗: 30 days from baseline
The THI questionnaire, widely used in research, including functional, emotional, and catastrophic subscales. It consists of 25 questions, and answers are rated on a "yes" (4 points), "sometimes" (2 points), and "no" (0 points) scale. The total score is calculated by adding up the scores for all questions and classifying the severity of tinnitus as no handicap (0-16), mild handicap (18-36), moderate handicap (38-56), and severe handicap (58-100).
次要结局
- Visual Analogue Scale (VAS)(30 days from baseline)
- Minimum Masking Level (MML)(30 days from baseline)
- Tinnitus Loudness Matching (LM)(30 days from baseline)
- Duration and intensity of residual inhibition (RI) for tinnitus(30 days from baseline)
- Self-rating Anxiety Scale (SAS)(30 days from baseline)
- Athens Insomnia Scale (AIS)(30 days from baseline)