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

NCT ID: NCT05856175

Last Updated: 2023-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-30

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pulsatile Tinnitus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beijing Friendship Hospital

OTHER

Sponsor Role lead

Responsible Party

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Wang, Zhenchang

Vice President, Director of Medical Imaging Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhenchang Wang, Prof.

Role: PRINCIPAL_INVESTIGATOR

Beijing Friendship Hospital

Locations

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Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Pengfei Zhao, Prof.

Role: CONTACT

+8613811048563

Facility Contacts

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Zhenchang Wang

Role: primary

+86-13501163497

Other Identifiers

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202304

Identifier Type: -

Identifier Source: org_study_id

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