Brain Imaging in Cerebral Venous Outflow Disturbance

Sponsor
Capital Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05820165
Collaborator
(none)
80
1
22
3.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
80 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Study on Brain Structure and Function Imaging in Patients With Cerebral Venous Outflow Disturbance
Actual Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. voxel-based morphometry [at admission]

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

Secondary Outcome Measures

  1. 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 Outcome Measures

  1. 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

  2. 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

  3. Tract-based spatial statistics (TBSS) analysis [at admission]

    Tract-based spatial statistics (TBSS) analysis is used to investigate fractional anisotropy (FA) values

  4. Mini-Mental State Examination(MMSE) [at admission]

    Mini-Mental State Examination(MMSE) is used to evaluate global cognitive function

  5. Montreal Cognitive Assessment (MoCA) [at admission]

    Montreal Cognitive Assessment (MoCA) is used to evaluate global cognitive function

  6. Subjective Cognitive Decline(SCD) [at admission]

    Subjective Cognitive Decline(SCD)is used to evaluate global cognitive function

  7. Self-Rating Anxiety Scale(SAS) [at admission]

    Self-Rating Anxiety Scale(SAS)is used to evaluate neuropsychological change

  8. Self-rating depression scale(SDS) [at admission]

    Self-rating depression scale(SDS)is used to evaluate neuropsychological change

  9. Pittsburgh sleep quality index(PSQI) [at admission]

    Pittsburgh sleep quality index(PSQI)is used to evaluate somnipathy

  10. Tinnitus handicap inventory(THI) [at admission]

    Tinnitus handicap inventory(THI)is used to evaluate tinnitus cerebri

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Xuanwu hospital;Capital Medical University Beijin XI Cheng District China 100053

Sponsors and Collaborators

  • Capital Medical University

Investigators

  • Principal Investigator: Xunming Ji, MD.PhD, Xuanwu Hospital, Beijing

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ji Xunming,MD,PhD, Professor, Capital Medical University
ClinicalTrials.gov Identifier:
NCT05820165
Other Study ID Numbers:
  • COVD-BI
First Posted:
Apr 19, 2023
Last Update Posted:
Apr 19, 2023
Last Verified:
Apr 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 19, 2023