Evaluation Criteria, Diagnostic Criteria, Surgical Indications, and Establishment of Surgical Standards for "Cerebral Tinnitus Syndrome" Caused by Internal Jugular Vein Stenosis.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 369
- 试验地点
- 1
- 主要终点
- Cerebral tinnitus improvement rate at 3 months postoperatively
研究概览
简要总结
"Cerebral Tinnitus," also known as "cranial tinnitus," refers to the patient-reported perception of intracranial sounds. It often presents as "Cerebral Tinnitus Syndrome," which includes symptoms such as tinnitus with hearing loss, headaches, a heavy head sensation, blurred vision, neck and shoulder discomfort, sleep disturbances, anxiety, and depression. Due to limited awareness of cerebral tinnitus, patients frequently seek treatment across multiple facilities without success, severely impacting their and their families' lives and work.
Xunming Ji and colleagues have pointed out that cerebral tinnitus results from stenosis of the cerebral or internal jugular veins (IJVS), which impairs cerebral venous outflow and the clearance of metabolic "waste," leading to chronic metabolic damage to brain cells. Currently, studies on the diagnosis and treatment of IJVS-induced cerebral tinnitus, both domestically and internationally, are primarily case reports, lacking systematic evaluation, diagnostic, and treatment standards, which significantly impacts patient outcomes.
Our project team is the first to establish evaluation criteria, diagnostic standards, surgical indications, and surgical standards for "Cerebral Tinnitus Syndrome." In preliminary work, we performed internal jugular vein (IJV) decompression on 32 cerebral tinnitus patients, resulting in an IJV morphological improvement rate of 84.3%, a blood flow improvement rate of 75.0%, and a cerebral tinnitus syndrome improvement rate of 62.5%. To date, we have completed 88 IJV decompression surgeries, making ours the largest clinical center for such cases worldwide. We continue to refine these standards, notably introducing new intraoperative standards for IJV "release" and "high perfusion,".
To validate and further study these standards, this project plans to perform IJV decompression surgery on 107 cerebral tinnitus patients affected by IJVS. We aim to establish a cerebral tinnitus database and develop a cerebral tinnitus evaluation scale to standardize evaluation criteria, diagnostic standards, surgical indications, and surgical standards, ultimately advancing clinical diagnosis and treatment of Cerebral Tinnitus Syndrome
详细描述
"Cerebral tinnitus," also known as "cranial tinnitus," is a condition where patients perceive intracranial sounds, often described as complex noises like machinery, thunder, or sirens, and may occur intermittently or persistently. Clinically, cerebral tinnitus is typically not an isolated symptom but manifests as "Cerebral Tinnitus Syndrome." In addition to cerebral tinnitus, patients frequently experience symptoms such as tinnitus with hearing loss, headaches and dizziness, head fullness or heaviness, dry eyes with blurred vision, neck and shoulder discomfort, sleep disturbances, anxiety, depression, and cognitive or memory decline.
A recent study published in the Journal of the American Medical Association: Neurology indicates that approximately 750 million people worldwide suffer from tinnitus. Due to the similarity between the symptoms of tinnitus and cerebral tinnitus, many tinnitus patients also experience cerebral tinnitus, making it difficult to distinguish between these symptoms accurately. Consequently, a substantial portion of the surveyed population may, in fact, be patients with "Cerebral Tinnitus Syndrome."
The fast-paced nature of modern life, coupled with increased stress from work and daily responsibilities, has contributed to the rising incidence of cerebral tinnitus, which has now become a common condition impacting quality of life and overall health in China. Unfortunately, effective treatments for "Cerebral Tinnitus Syndrome" remain unavailable. With limited public awareness about cerebral tinnitus, many patients seek medical help without success; conventional medications yield limited results, and patients often rely on anti-anxiety or antidepressant medications to alleviate symptoms, which severely impacts their and their families' lives and work.
Currently, the etiology of cerebral tinnitus remains unclear. Some studies suggest it may be related to alterations in blood flow within the dural sinuses or internal jugular veins (IJVs) caused by head and neck venous return obstruction or compensatory blood flow in collateral veins. Ji Xunming et al. proposed that cerebral tinnitus could result from stenosis of the cerebral or internal jugular veins, leading to impaired cerebral venous return, inadequate clearance of metabolic waste, and chronic metabolic alterations in brain cells. Specific causes may include cerebral venous thrombosis (CVT), cerebral venous sinus stenosis (CVSS), and internal jugular vein stenosis (IJVS). Unlike CVT and CVSS, IJVS is often caused by external compression, with the transverse process of the atlas and styloid process being primary contributors, affecting 40-70% of cases.
Currently, treatment approaches for cerebral tinnitus are primarily symptom-focused, lacking effective interventions targeting the underlying cause. Medications such as antidepressants and anxiolytics are mainly used to alleviate emotional symptoms, while steroids may temporarily reduce inflammatory responses associated with tinnitus, yet do not address IJVS-induced cerebral tinnitus. Audiotherapy and psychotherapy may improve psychological responses to symptoms but fail to treat the root cause. Surgical interventions may offer symptom relief in some cases with clear etiology; however, there are only a few case reports. Most available treatments are symptomatic rather than causal, underscoring the need for standardized diagnostic and treatment protocols for IJVS-induced cerebral tinnitus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 75 years, with no gender restriction.
- •Presence of one or more symptoms associated with "Cerebral Tinnitus Syndrome," with a duration of at least 3 months.
- •Following a detailed medical history and comprehensive physical examination, other known causes of cerebral tinnitus are preliminarily excluded, with suspected internal jugular vein stenosis (IJVS) as the cause.
- •Imaging studies (e.g., jugular ultrasound, cervical venous CT venography (CTV)) show significant stenosis in the internal jugular vein (stenosis degree ≥50%).
- •The patient has provided informed consent and voluntarily agrees to participate in the study, with a signed informed consent form.
排除标准
- •Patients with a history of cranial surgery or diagnosed intracranial space-occupying lesions.
- •Patients with severe cardiac, hepatic, or renal insufficiency, or other systemic diseases.
- •Patients who have undergone any surgical or interventional procedures affecting jugular venous flow within the last 6 months.
- •Patients with a history of psychiatric disorders or cognitive impairment who cannot complete study evaluations.
- •Pregnant or breastfeeding women.
研究组 & 干预措施
Surgical Intervention Group
Internal Jugular Vein Decompression is a surgical procedure designed to relieve stenosis or external compression of the internal jugular vein, restore normal cerebral venous outflow, and alleviate symptoms related to chronic venous congestion such as pulsatile tinnitus (tinnitus cerebri), positional headache, and visual disturbances.It can be performed via open surgical decompression (releasing surrounding soft tissue/bony compression) or endovascular intervention (balloon angioplasty/stenting) to treat significant jugular vein stenosis refractory to medical management.
干预措施: Atlas Transverse Process Mastoidectomy with Lysis and Perfusion (Procedure)
结局指标
主要结局
Cerebral tinnitus improvement rate at 3 months postoperatively
时间窗: 3 months postoperatively
Assessed by VAS score (0-10). Improvement defined as: Marked improvement: ≥30% reduction in VAS Mild improvement: 10%-30% reduction No obvious change: 0%-10% reduction Aggravation: increased VAS
次要结局
- Cerebral tinnitus improvement rate at 12 months postoperatively(12 months postoperatively)
- Improvement rate of other clinical symptoms at 3 and 12 months postoperatively(3 and 12 months postoperatively)
- Morphological improvement of the internal jugular vein (IJV) postoperatively(3 and 12 months postoperatively)
- Blood flow recovery of IJV postoperatively(3 and 12 months postoperatively)
- Safety outcomes(3 and 12 months postoperatively)
