Clinical trial NCT05856175: The Recurrence Mechanism of Venous Tinnitus After Boney Wall Reconstruction Based on Multimodal Imaging and Multiphysics Coupling
Official title: The Recurrence Mechanism of Venous Tinnitus After Boney Wall Reconstruction Based on Multimodal Imaging and Multiphysics Coupling
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulsatile Tinnitus
Keywords: magnetic resonance angiography
head and neck
ear
pulsatile tinnitus
hemodynamics
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2023-05-12
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * postoperative recurrence patients：100 cases
* no postoperative recurrence patients：50 cases

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.


Eligibility criteria: 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

Primary outcomes:
measure: the influence of peri-sinus bony wall morphology on the recurrence of pulsatile tinnitus using CT
timeFrame: 2023.6.1-2025.12.31
measure: the influence of venous sinus morphology, intra-sinus blood flow, and intra-sinus pressure on the recurrence of pulsatile tinnitus using MRI
timeFrame: 2023.6.1-2025.12.31
measure: the influence of cerebral perfusion on the recurrence of pulsatile tinnitus using MRI
timeFrame: 2023.6.1-2025.12.31
measure: the influence of blood flow impact, sinus wall pressure and peri-sinus bone wall deformation on the recurrence of pulsatile tinnitus
timeFrame: 2023.6.1-2025.12.31
measure: the risk factors and their weights of pulsatile tinnitus recurrence
timeFrame: 2023.6.1-2025.12.31
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Friendship Hospital
name: Zhenchang Wang, Prof.
role: PRINCIPAL_INVESTIGATOR
References: