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

NCT07560280 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 369

Last updated 2026-05-01

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Beijing Shijitan Hospital, Capital Medical University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-07
Primary Completion
2029-12-30
Completion
2030-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07560280 on ClinicalTrials.gov