Brain Imaging in Cerebral Venous Outflow Disturbance

NCT05820165 | Unknown DMC

• 1 other identifier: COVD-BI
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Cerebral venous outflow disturbance can lead to cerebral hemodynamic disturbances, altered cerebrospinal fluid dynamics, cerebral venous blood stasis, increased cerebral venous pressure and decreased cerebral perfusion, cerebral white matter sparing-like changes, and widening of retinal vessel diameter. These changes are associated with numerous neurological signs and symptoms. Therefore, understanding the brain structural and functional changes in patients with cerebral venous outflow disturbance is essential to provide specific imaging evaluation indicators and new diagnosis and treatment methods for patients with cerebral venous return disorders.

Conditions

Abnormal Cerebral Venous Sinus Morphology; Internal Jugular Vein Stenosis; Image

Outcome Measures

Primary Outcomes (1)

• voxel-based morphometry

  Voxel-based morphometry (VBM) is used to obtain the relative gray matter volume (GMV) and WM volume (WMV)

  at admission

Secondary Outcomes (1)

• The amplitude of low-frequency fluctuations (ALFF)

  at admission

Other Outcomes (10)

• Regional homogeneity (ReHo)

  at admission

• Voxel-wise functional connectivity (FC)

  at admission

• Tract-based spatial statistics (TBSS) analysis

  at admission

Study Arms (3)

CVOD-WS

Cerebral Venous Outflow Disturbance with symptoms such as tinnitus cerebri，somnipathy ，anxiety ，depression and cognitive decline

Radiation: high-resolution 3D-T1; Radiation: diffusion tensor imaging (DTI); Radiation: resting-state functional magnetic resonance imaging (rs-fMRI); Radiation: arterial spin labeling (ASL) perfusion magnetic resonance imaging (MRI); Radiation: susceptibility-weighted images (SWIs)

CVOD-WOS

Cerebral Venous Outflow Disturbance without symptoms such as tinnitus cerebri，somnipathy ，anxiety ，depression and cognitive decline

Radiation: high-resolution 3D-T1; Radiation: diffusion tensor imaging (DTI); Radiation: resting-state functional magnetic resonance imaging (rs-fMRI); Radiation: arterial spin labeling (ASL) perfusion magnetic resonance imaging (MRI); Radiation: susceptibility-weighted images (SWIs)

HC

Healthy control

Radiation: high-resolution 3D-T1; Radiation: diffusion tensor imaging (DTI); Radiation: resting-state functional magnetic resonance imaging (rs-fMRI); Radiation: arterial spin labeling (ASL) perfusion magnetic resonance imaging (MRI); Radiation: susceptibility-weighted images (SWIs)

Interventions

high-resolution 3D-T1 RADIATION

Subjects undergo a high-resolution 3D-T1 imaging to obtain structural images

CVOD-WOS; CVOD-WS; HC

diffusion tensor imaging (DTI) RADIATION

Subjects undergo a DTI imaging to obtain images of white matter lesions

CVOD-WOS; CVOD-WS; HC

resting-state functional magnetic resonance imaging (rs-fMRI) RADIATION

Subjects undergo rs-fMRI to investigate the differences in intra-regional brain activity and inter-regional functional connectivity

CVOD-WOS; CVOD-WS; HC

arterial spin labeling (ASL) perfusion magnetic resonance imaging (MRI) RADIATION

Subjects undergo arterial spin labeling (ASL) perfusion magnetic resonance imaging (MRI) to clarify the difference of cerebral blood flow (CBF) perfusion in certain regions

CVOD-WOS; CVOD-WS; HC

susceptibility-weighted images (SWIs) RADIATION

Subjects undergo susceptibility-weighted images (SWIs) to segment the vein network

CVOD-WOS; CVOD-WS; HC

Eligibility Criteria

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

Study Population

Patients with cerebral venous outflow disturbance( moderate to severe stenosis in cerebral venous sinus or intracranial jugular veins )

You may qualify if:

• Cerebral venous outflow disturbance( moderate to severe stenosis in cerebral venous sinus or intracranial jugular veins ) is confirmed by two of magnetic resonance venography (MRV), computed tomography venography (CTV) or digital subtraction angiography (DSA)
• Accompanying symptoms such as tinnitus cerebri, cognitive decline, anxiety depression, sleep disorders, etc. for more than 6 months

You may not qualify if:

• ear primary disease medicine related intracranial hypertension; Systemic disease of abnormal metabolism or inflammation; moderate to severe stenosis in intracranial, carotid or vertebral arteries; intracranial lesions.

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Xuanwu hospital;Capital Medical University

Beijin, XI Cheng District, 100053, China

RECRUITING

Related Publications (1)

• Luan Y, Wang C, Jiao Y, Tang T, Zhang J, Teng GJ. Prefrontal-Temporal Pathway Mediates the Cross-Modal and Cognitive Reorganization in Sensorineural Hearing Loss With or Without Tinnitus: A Multimodal MRI Study. Front Neurosci. 2019 Mar 12;13:222. doi: 10.3389/fnins.2019.00222. eCollection 2019.

  PMID: 30930739 BACKGROUND

Biospecimen

Retention: NONE RETAINED

Blood samples from enrolled participants are drawn by nurse using containing coagulant tubes.

MeSH Terms

Interventions

Diffusion Tensor Imaging

Intervention Hierarchy (Ancestors)

Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diffusion Magnetic Resonance Imaging; Magnetic Resonance Imaging; Tomography; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• Xunming Ji, MD.PhD

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xunming Ji

CONTACT

010-83199430; jixm@ccmu.edu.cn

Lu Liu, MD

CONTACT

13370186128; bingtangjiaozi@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 14, 2023
• First Posted: April 19, 2023
• Study Start: March 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: April 19, 2023

Record last verified: 2023-04

Locations

CN (1)