The Recurrence Mechanism of Venous Tinnitus After Boney Wall Reconstruction Based on Multimodal Imaging and Multiphysics Coupling

Pulsatile Tinnitus Clinical Trial

Official title:

The Recurrence Mechanism of Venous Tinnitus After Boney Wall Reconstruction Based on Multimodal Imaging and Multiphysics Coupling

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05856175
• Other study ID #: 202304
• Status: Recruiting
• Start date: June 2023
• Est. completion date: December 2025

Study information

• Verified date: May 2023
• Source: Beijing Friendship Hospital
• Contact: Pengfei Zhao, Prof.
• Phone: +8613811048563
• Email: zhaopengf05[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Venous tinnitus (VT) is seriously affecting the quality of life of five million patients in China. Bony wall reconstruction is the main treatment method, but the postoperative recurrence rate exceeds 30%, and the specific mechanism is unclear. Based on our previous work, a scientific hypothesis was put forward: the key to the recurrence of V T is pathologic remodeling of the peri-sinus bony wall mediated by the venous sinus morphology, blood flow, and pressure after surgical reconstruction. As a continuation of the National Natural Science Foundation of China-Youth Project, this project intends to combine multimodal imaging technology, multiphysics coupled numerical model and machine learning method to analyze analyze the data after bone wall reconstruction in multiple dimensions: ① To explore the influence of peri-sinus bony wall morphology, venous sinus morphology, intra-sinus blood flow, intra-sinus pressure, and cerebral perfusion on the recurrence of VT using ultra-high resolution CT, vessel wall MR, 4D Flow MR and ASL MR imaging technology; ② To explore the influence of blood flow impact, sinus wall pressure and peri-sinus bone wall deformation on the recurrence of VT using multiphysics coupling numerical model with vessel, blood flow, bone and acoustic fields; ③ To determine the risk factors and their weights of VT recurrence using machine learning methods, and to establish a personalized surgical planning and prognostic evaluation models; Thus, to verify the hemodynamic and biomechanical mechanisms of VPT recurrence to achieve personalized and effectively treatment. This project may prevent and warn the recurrence of VPT after bony wall reconstruction.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patients with venous tinnitus, a rhythmic noise that follows the heart beating without external stimuli and can disappear or significantly reduce after compression of the affected side of the neck
• the normal otoscopy
• venous tinnitus patients with confirmed sigmoid sinus wall dehiscence with or without sigmoid sinuses enlargement, diverticula and transverse sinuses stenosis using dual-phase enhanced CT examination
• preoperative DSA examination
• bone wall reconstruction

Exclusion Criteria:

• contraindications for CT and MR Examination
• tumor and arterial abnormalities

Related Conditions & MeSH terms

• Pulsatile Tinnitus
• Recurrence
• Tinnitus

Locations

Country	Name	City	State
China	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the influence of peri-sinus bony wall morphology on the recurrence of pulsatile tinnitus using CT	ultra-high resolution CT	2023.6.1-2025.12.31
Primary	the influence of venous sinus morphology, intra-sinus blood flow, and intra-sinus pressure on the recurrence of pulsatile tinnitus using MRI	4D Flow MR imaging technology	2023.6.1-2025.12.31
Primary	the influence of cerebral perfusion on the recurrence of pulsatile tinnitus using MRI	ASL MR imaging technology	2023.6.1-2025.12.31
Primary	the influence of blood flow impact, sinus wall pressure and peri-sinus bone wall deformation on the recurrence of pulsatile tinnitus	multiphysics coupling numerical model with vessel, blood flow, bone and acoustic fields	2023.6.1-2025.12.31
Primary	the risk factors and their weights of pulsatile tinnitus recurrence	Ensight, a post-processing software, was used to study the interaction between hemodynamic features and acoustic features with multivariate analysis and machine learning methods.	2023.6.1-2025.12.31