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

Sponsor

Beijing Friendship Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05856175

Collaborator

(none)

150

Enrollment

Location

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pulsatile Tinnitus

Study Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
PT patients with postoperative recurrence participants in this group undergo ultra-high resolution CT, vessel wall MR, 4D Flow MR and ASL MR imaging technology before and after surgery.
PT patients without postoperative recurrence participants in this group undergo ultra-high resolution CT, vessel wall MR, 4D Flow MR and ASL MR imaging technology before and after surgery.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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