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

NCT07560280 | Recruiting DMC

• 2 other identifiers: BeijingShijitanHCapitalMU sjwkZLRK202512
• Study Type: interventional
• Target: 369
• Locations: 1 country
• Sites: 1

Brief Summary

"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

Conditions

Jugular Vein Anomaly (Disorder); Diagnostic Self Evaluation; Nerosurgery; Assessment, Self

Keywords

Non-randomized Controlled Clinical Trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (1)

Surgical Intervention Group

EXPERIMENTAL

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

Interventions

Atlas Transverse Process Mastoidectomy with Lysis and Perfusion PROCEDURE

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

Surgical Intervention Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Shijitan Hospital, Capital Medical University: lead

Study Sites (1)

Beijing Shijitan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100038, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 31164090 BACKGROUND

MeSH Terms

Interventions

Perfusion

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

Zhiqiang Hu

CONTACT

86+13501378609; neuro7@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: May 1, 2026
• Study Start: May 7, 2025
• Primary Completion (Estimated): December 30, 2029
• Study Completion (Estimated): December 30, 2030
• Last Updated: May 1, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• 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\*\*.
• Access Criteria: Clinical Study Report (CSR)

Locations

CN (1)