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Brain Imaging in Cerebral Venous Outflow Disturbance

NCT05820165 — Unknown, 80 participants, Capital Medical University

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

RegistryNCT05820165
StatusUnknown
Study typeObservational
Enrollment80 (Estimated)
SponsorCapital Medical University (Other)
ConditionsAbnormal Cerebral Venous Sinus Morphology, Internal Jugular Vein Stenosis, Image
Interventionshigh-resolution 3D-T1, diffusion tensor imaging (DTI), resting-state functional magnetic resonance imaging (rs-fMRI), arterial spin labeling (ASL) perfusion magnetic resonance imaging (MRI), susceptibility-weighted images (SWIs) (Radiation)
Datesstart 2023-03-01, primary completion 2023-12-31 (estimated), completion 2024-12-31 (estimated), first posted 2023-04-19, last updated 2023-04-19
Locations1 site in China

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-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
CVOD-WSRadiation: 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)Cerebral Venous Outflow Disturbance with symptoms such as tinnitus cerebri,somnipathy ,anxiety ,depression and cognitive decline
CVOD-WOSRadiation: 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)Cerebral Venous Outflow Disturbance without symptoms such as tinnitus cerebri,somnipathy ,anxiety ,depression and cognitive decline
HCRadiation: 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)Healthy control
  • high-resolution 3D-T1 (Radiation): Subjects undergo a high-resolution 3D-T1 imaging to obtain structural images
  • diffusion tensor imaging (DTI) (Radiation): Subjects undergo a DTI imaging to obtain images of white matter lesions
  • 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
  • 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
  • susceptibility-weighted images (SWIs) (Radiation): Subjects undergo susceptibility-weighted images (SWIs) to segment the vein network

+Outcome measures

Primary outcomes

  • voxel-based morphometry [at admission]: Voxel-based morphometry (VBM) is used to obtain the relative gray matter volume (GMV) and WM volume (WMV)

Secondary outcomes

  • The amplitude of low-frequency fluctuations (ALFF) [at admission]: The amplitude of low-frequency fluctuations (ALFF) is used to investigate the differences in intra-regional brain activity and inter-regional functional connectivity

Other outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

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.

+Locations (1)

FacilityCityCountryStatus
Xuanwu hospital;Capital Medical UniversityBeijin, XI Cheng DistrictChinaRecruiting

+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. PMID 30930739

+Investigators

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