Brain Imaging in Cerebral Venous Outflow Disturbance

Study on Brain Structure and Function Imaging in Patients With Cerebral Venous Outflow Disturbance

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.

Study Overview

• Status: Recruiting
• Conditions: Image; Abnormal Cerebral Venous Sinus Morphology; Internal Jugular Vein Stenosis
• Intervention / Treatment: 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)

Detailed Description

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. A number of central nervous system disorders such as transient global amnesia, transient monocular blindness, primary labor headaches, and even Parkinson's have been reported to be closely associated with internal jugular vein stenosis. Other common clinical manifestations include sleep disturbances, tinnitus, tinnitus, headache, visual impairment, optic papilledema, hearing loss, cognitive decline and neck discomfort and even autonomic dysfunction. The main objective of this study is to investigate the structural and functional network changes in patients with cerebral venous outflow disturbance using different brain imaging techniques, to clarify the correlation between symptoms of cerebral venous outflow disturbance and brain structure and function; to identify areas with corresponding structural and functional changes in patients with cerebral venous outflow disturbance and or comorbid symptoms, and to provide specific imaging assessment indicators and new diagnostic and treatment tools for patients with cerebral venous outflow disturbance and comorbid symptoms.

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: Xunming Ji; Phone Number: 010-83199430; Email: jixm@ccmu.edu.cn

Study Locations

• China
  • XI Cheng District
    • Beijin, XI Cheng District, China, 100053
      • Recruiting
      • Xuanwu hospital;Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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 )

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CVOD-WS; Cerebral Venous Outflow Disturbance with symptoms such as tinnitus cerebri，somnipathy ，anxiety ，depression and cognitive decline	Radiation: high-resolution 3D-T1; Subjects undergo a high-resolution 3D-T1 imaging to obtain structural images; Radiation: diffusion tensor imaging (DTI); Subjects undergo a DTI imaging to obtain images of white matter lesions; Radiation: resting-state functional magnetic resonance imaging (rs-fMRI); Subjects undergo rs-fMRI to investigate the differences in intra-regional brain activity and inter-regional functional connectivity; Radiation: arterial spin labeling (ASL) perfusion magnetic resonance imaging (MRI); Subjects undergo arterial spin labeling (ASL) perfusion magnetic resonance imaging (MRI) to clarify the difference of cerebral blood flow (CBF) perfusion in certain regions; Radiation: susceptibility-weighted images (SWIs); Subjects undergo susceptibility-weighted images (SWIs) to segment the vein network
CVOD-WOS; Cerebral Venous Outflow Disturbance without symptoms such as tinnitus cerebri，somnipathy ，anxiety ，depression and cognitive decline	Radiation: high-resolution 3D-T1; Subjects undergo a high-resolution 3D-T1 imaging to obtain structural images; Radiation: diffusion tensor imaging (DTI); Subjects undergo a DTI imaging to obtain images of white matter lesions; Radiation: resting-state functional magnetic resonance imaging (rs-fMRI); Subjects undergo rs-fMRI to investigate the differences in intra-regional brain activity and inter-regional functional connectivity; Radiation: arterial spin labeling (ASL) perfusion magnetic resonance imaging (MRI); Subjects undergo arterial spin labeling (ASL) perfusion magnetic resonance imaging (MRI) to clarify the difference of cerebral blood flow (CBF) perfusion in certain regions; Radiation: susceptibility-weighted images (SWIs); Subjects undergo susceptibility-weighted images (SWIs) to segment the vein network
HC; Healthy control	Radiation: high-resolution 3D-T1; Subjects undergo a high-resolution 3D-T1 imaging to obtain structural images; Radiation: diffusion tensor imaging (DTI); Subjects undergo a DTI imaging to obtain images of white matter lesions; Radiation: resting-state functional magnetic resonance imaging (rs-fMRI); Subjects undergo rs-fMRI to investigate the differences in intra-regional brain activity and inter-regional functional connectivity; Radiation: arterial spin labeling (ASL) perfusion magnetic resonance imaging (MRI); Subjects undergo arterial spin labeling (ASL) perfusion magnetic resonance imaging (MRI) to clarify the difference of cerebral blood flow (CBF) perfusion in certain regions; Radiation: susceptibility-weighted images (SWIs); Subjects undergo susceptibility-weighted images (SWIs) to segment the vein network

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
voxel-based morphometry	Voxel-based morphometry (VBM) is used to obtain the relative gray matter volume (GMV) and WM volume (WMV)	at admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The amplitude of low-frequency fluctuations (ALFF)	The amplitude of low-frequency fluctuations (ALFF) is used to investigate the differences in intra-regional brain activity and inter-regional functional connectivity	at admission

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Regional homogeneity (ReHo)	The Regional homogeneity (ReHo) is used to investigate the differences in intra-regional brain activity and inter-regional functional connectivity	at admission
Voxel-wise functional connectivity (FC)	The Voxel-wise functional connectivity (FC) is used to investigate the differences in intra-regional brain activity and inter-regional functional connectivity	at admission
Tract-based spatial statistics (TBSS) analysis	Tract-based spatial statistics (TBSS) analysis is used to investigate fractional anisotropy (FA) values	at admission
Mini-Mental State Examination(MMSE)	Mini-Mental State Examination(MMSE) is used to evaluate global cognitive function	at admission
Montreal Cognitive Assessment (MoCA)	Montreal Cognitive Assessment (MoCA) is used to evaluate global cognitive function	at admission
Subjective Cognitive Decline（SCD）	Subjective Cognitive Decline（SCD）is used to evaluate global cognitive function	at admission
Self-Rating Anxiety Scale（SAS）	Self-Rating Anxiety Scale（SAS）is used to evaluate neuropsychological change	at admission
Self-rating depression scale（SDS）	Self-rating depression scale（SDS）is used to evaluate neuropsychological change	at admission
Pittsburgh sleep quality index（PSQI）	Pittsburgh sleep quality index（PSQI）is used to evaluate somnipathy	at admission
Tinnitus handicap inventory（THI）	Tinnitus handicap inventory（THI）is used to evaluate tinnitus cerebri	at admission

Collaborators and Investigators

• Sponsor: Capital Medical University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: April 14, 2023
• First Submitted That Met QC Criteria: April 14, 2023
• First Posted (Actual): April 19, 2023

Study Record Updates

• Last Update Posted (Actual): April 19, 2023
• Last Update Submitted That Met QC Criteria: April 14, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: COVD-BI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No