Brain Imaging in Cerebral Venous Outflow Disturbance

Image Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05820165
• Other study ID #: COVD-BI
• Status: Recruiting
• Start date: March 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2023
• Source: Capital Medical University
• Contact: Xunming Ji
• Phone: 010-83199430
• Email: jixm[@]ccmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Image

Intervention

Radiation:
• high-resolution 3D-T1
Subjects undergo a high-resolution 3D-T1 imaging to obtain structural images
• diffusion tensor imaging (DTI)
Subjects undergo a DTI imaging to obtain images of white matter lesions
• 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
• 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
• susceptibility-weighted images (SWIs)
Subjects undergo susceptibility-weighted images (SWIs) to segment the vein network

Locations

Country	Name	City	State
China	Xuanwu hospital;Capital Medical University	Beijin	XI Cheng District

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	Tract-based spatial statistics (TBSS) analysis	Tract-based spatial statistics (TBSS) analysis is used to investigate fractional anisotropy (FA) values	at admission
Other	Mini-Mental State Examination(MMSE)	Mini-Mental State Examination(MMSE) is used to evaluate global cognitive function	at admission
Other	Montreal Cognitive Assessment (MoCA)	Montreal Cognitive Assessment (MoCA) is used to evaluate global cognitive function	at admission
Other	Subjective Cognitive Decline(SCD)	Subjective Cognitive Decline(SCD)is used to evaluate global cognitive function	at admission
Other	Self-Rating Anxiety Scale(SAS)	Self-Rating Anxiety Scale(SAS)is used to evaluate neuropsychological change	at admission
Other	Self-rating depression scale(SDS)	Self-rating depression scale(SDS)is used to evaluate neuropsychological change	at admission
Other	Pittsburgh sleep quality index(PSQI)	Pittsburgh sleep quality index(PSQI)is used to evaluate somnipathy	at admission
Other	Tinnitus handicap inventory(THI)	Tinnitus handicap inventory(THI)is used to evaluate tinnitus cerebri	at admission
Primary	voxel-based morphometry	Voxel-based morphometry (VBM) is used to obtain the relative gray matter volume (GMV) and WM volume (WMV)	at admission
Secondary	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