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

NCT05856175 | Unknown

• 1 other identifier: 202304
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulsatile Tinnitus

Keywords

magnetic resonance angiography; head and neck; ear; pulsatile tinnitus; hemodynamics

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• the influence of cerebral perfusion on the recurrence of pulsatile tinnitus using MRI

  ASL MR imaging technology

  2023.6.1-2025.12.31

• 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

• 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

Study Arms (2)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* postoperative recurrence patients：100 cases * no postoperative recurrence patients：50 cases

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (1)

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

RECRUITING

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Zhenchang Wang, Prof.

  Beijing Friendship Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pengfei Zhao, Prof.

CONTACT

+8613811048563; zhaopengf05@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President, Director of Medical Imaging Center

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 12, 2023
• Study Start: June 1, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 12, 2023

Record last verified: 2023-05

Locations

CN (1)