Evaluation Criteria, Diagnostic Criteria, Surgical Indications, and Establishment of Surgical Standards for "Cerebral Tinnitus Syndrome" Caused by Internal Jugular Vein Stenosis.

"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

Study Overview

• Status: Recruiting
• Conditions: Diagnostic Self Evaluation; Assessment, Self; Jugular Vein Anomaly (Disorder); Nerosurgery
• Intervention / Treatment: Procedure: Atlas Transverse Process Mastoidectomy with Lysis and Perfusion

Detailed Description

"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.

Systematic research on surgical interventions for IJVS has developed relatively recently. In 2021, Ji Xunming and colleagues summarized recent advancements in IJVS diagnosis and treatment, identifying the upper segment of the internal jugular vein as vulnerable to compression by the atlas transverse process and styloid process. For IJVS patients with distinct bony compression, surgical resection of the compressive bone has been reported to alleviate preoperative symptoms such as headaches, dizziness, and cognitive impairment. Dashti et al. reported on two IJVS patients with craniovertebral junction compression, whose symptoms improved after partial bone resection. Fritch et al. presented a case of IJVS with intracranial hypertension caused by compression from the C1 transverse process, which improved rapidly after resection. Higgins et al. examined 29 styloidectomy surgeries in IJVS patients, finding that of 23 patients undergoing the procedure for the first time without stenting, one achieved complete symptom resolution, four experienced symptom improvement, while the remaining 18 required stenting within two months. Yang et al. reported clinical improvement in 11 of 14 IJVS patients treated with condylar suboccipital lateral approach decompression. From the literature, only limited case studies and small clinical cohorts abroad focus on surgical treatment for IJVS, with no related literature from domestic studies. Additionally, there are no standardized evaluation, diagnostic, or treatment protocols for Cerebral Tinnitus Syndrome caused by IJVS.

Our team is the first globally to establish evaluation criteria, diagnostic standards, surgical indications, and surgical protocols for "Cerebral Tinnitus Syndrome" induced by IJVS. In previous work, we performed internal jugular vein (IJV) decompression on 32 patients with cerebral tinnitus, achieving an IJV morphological improvement rate of 84.3% (27/32), a blood flow improvement rate of 75.0% (24/32), and a cerebral tinnitus syndrome improvement rate of 62.5% (20/32). To date, we have completed 88 minimally invasive surgeries for IJVS-induced cerebral tinnitus, establishing the largest clinical center for these cases worldwide. We continue to refine standards, notably introducing intraoperative IJV "release" and "high perfusion" as new surgical criteria.

To further validate and expand upon these standards, this study plans to perform IJV decompression on 107 patients with IJVS-induced Cerebral Tinnitus Syndrome. Key surgical steps include: (1) standardized bony decompression, (2) soft tissue release, and (3) IJV high perfusion. Enrolled patients will undergo structured evaluation based on our established IJVS-induced Cerebral Tinnitus Syndrome assessment criteria, including "clinical symptom assessment, imaging assessment, and multidisciplinary collaborative evaluation." From these assessments, we will develop more precise diagnostic criteria and clinical classifications. Surgery will be guided by stricter surgical indications to ensure optimal patient selection, and intraoperative validation of the new techniques (standardized bony decompression, soft tissue release, and IJV high perfusion) will be conducted to achieve complete J3 segment decompression. This will set new surgical operation standards, establish a cerebral tinnitus database, create an evaluation scale for cerebral tinnitus, and examine key factors influencing clinical efficacy of IJV decompression. Through this research, we aim to enhance clinical diagnosis and treatment capabilities for IJVS-induced Cerebral Tinnitus Syndrome, relieving patient suffering and improving quality of life.

• Study Type: Interventional
• Enrollment (Estimated): 369
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhiqiang Hu; Phone Number: 86+13501378609; Email: neuro7@163.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100038
      • Recruiting
      • Beijing Shijitan Hospital, Capital Medical University
      • Contact: Zhiqiang Hu; Phone Number: 86+13501378609; Email: neuro7@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Age between 18 and 75 years, with no gender restriction.
2. Presence of one or more symptoms associated with "Cerebral Tinnitus Syndrome," with a duration of at least 3 months.
3. 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.
4. Imaging studies (e.g., jugular ultrasound, cervical venous CT venography (CTV)) show significant stenosis in the internal jugular vein (stenosis degree ≥50%).
5. The patient has provided informed consent and voluntarily agrees to participate in the study, with a signed informed consent form.

Exclusion Criteria:

1. Patients with a history of cranial surgery or diagnosed intracranial space-occupying lesions.
2. Patients with severe cardiac, hepatic, or renal insufficiency, or other systemic diseases.
3. Patients who have undergone any surgical or interventional procedures affecting jugular venous flow within the last 6 months.
4. Patients with a history of psychiatric disorders or cognitive impairment who cannot complete study evaluations.
5. Pregnant or breastfeeding women.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Procedure: Atlas Transverse Process Mastoidectomy with Lysis and Perfusion; This surgical procedure is performed with the patient in the lateral decubitus position (affected side up), under electrophysiological monitoring of the sternocleidomastoid and trapezius muscles. A 3-4 cm straight incision is made below the mastoid tip, and the atlas transverse process is exposed via careful dissection along the anterior border of the sternocleidomastoid muscle while preserving the cervical branch of the facial nerve. Under endoscopy and microscopy, the anterolateral portion of the transverse process is thoroughly drilled using diamond burrs (4 mm and 2 mm) according to preoperative CTV measurements. After bone resection, the carotid sheath is opened to expose the internal jugular vein (IJV), and perivascular soft tissues are fully released over a width of more than 2 cm to decompress the entire J3 segment of the IJV. Subsequently, the systolic blood pressure is elevated by at least 20% above baseline and maintained for 30 minutes to achieve IJV hyperperfusion and prom

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cerebral tinnitus improvement rate at 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	3 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cerebral tinnitus improvement rate at 12 months postoperatively	Assessed by VAS score (0-10) with the same improvement criteria.	12 months postoperatively
Improvement rate of other clinical symptoms at 3 and 12 months postoperatively	Assessed by VAS score (0-10) with the same improvement criteria.	3 and 12 months postoperatively
Morphological improvement of the internal jugular vein (IJV) postoperatively	Assessed by CTV; improvement defined by percentage increase in IJV diameter at decompressed segment.	3 and 12 months postoperatively
Blood flow recovery of IJV postoperatively	Assessed by Doppler ultrasound; improvement defined by percentage increase in blood flow velocity at IJV J3 segment	3 and 12 months postoperatively
Safety outcomes	Incidence of adverse events (AEs) and serious adverse events (SAEs), including intraoperative vascular/nerve injury, wound infection, neck-shoulder discomfort, and limited neck movement.	3 and 12 months postoperatively

Collaborators and Investigators

• Sponsor: Beijing Shijitan Hospital, Capital Medical University

Publications and helpful links

General Publications

• Li M, Sun Y, Chan CC, Fan C, Ji X, Meng R. Internal jugular vein stenosis associated with elongated styloid process: five case reports and literature review. BMC Neurol. 2019 Jun 4;19(1):112. doi: 10.1186/s12883-019-1344-0.

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2025
• Primary Completion (Estimated): December 30, 2029
• Study Completion (Estimated): December 30, 2030

Study Registration Dates

• First Submitted: April 24, 2026
• First Submitted That Met QC Criteria: April 24, 2026
• First Posted (Actual): May 1, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Non-randomized Controlled Clinical Trial
• Additional Relevant MeSH Terms: Investigative Techniques; Perfusion
• Other Study ID Numbers: BeijingShijitanHCapitalMU sjwk; ZLRK202512 (Other Grant/Funding Number: Beijing Municipal Hospital Management Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Baseline demographic data (age, gender, body mass index, medical history). Preoperative and postoperative VAS scores for tinnitus cerebri and other clinical symptoms at 3 and 12 months.

Imaging measurements: IJV diameter on CTV at the decompressed segment pre- and postoperatively.

Hemodynamic data: blood flow velocity of the IJV J3 segment measured by Doppler ultrasound.

Safety data: occurrence, time, and severity of adverse events and serious adverse events.

Data will be shared after de-identification, without exposing participant privacy or protected health information.

• IPD Sharing Time Frame: The IPD and related supporting information will be made available **starting from the date of study completion**, and will remain accessible for **5 years after the end of the study**.
• IPD Sharing Access Criteria: Clinical Study Report (CSR)
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No