Brain Imaging in Cerebral Venous Outflow Disturbance

April 14, 2023 updated by: Ji Xunming,MD,PhD, Capital Medical University

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
voxel-based morphometry
Time Frame: at admission
Voxel-based morphometry (VBM) is used to obtain the relative gray matter volume (GMV) and WM volume (WMV)
at admission

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The amplitude of low-frequency fluctuations (ALFF)
Time Frame: 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
at admission

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Regional homogeneity (ReHo)
Time Frame: at admission
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)
Time Frame: at admission
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
Time Frame: at admission
Tract-based spatial statistics (TBSS) analysis is used to investigate fractional anisotropy (FA) values
at admission
Mini-Mental State Examination(MMSE)
Time Frame: at admission
Mini-Mental State Examination(MMSE) is used to evaluate global cognitive function
at admission
Montreal Cognitive Assessment (MoCA)
Time Frame: at admission
Montreal Cognitive Assessment (MoCA) is used to evaluate global cognitive function
at admission
Subjective Cognitive Decline（SCD）
Time Frame: at admission
Subjective Cognitive Decline（SCD）is used to evaluate global cognitive function
at admission
Self-Rating Anxiety Scale（SAS）
Time Frame: at admission
Self-Rating Anxiety Scale（SAS）is used to evaluate neuropsychological change
at admission
Self-rating depression scale（SDS）
Time Frame: at admission
Self-rating depression scale（SDS）is used to evaluate neuropsychological change
at admission
Pittsburgh sleep quality index（PSQI）
Time Frame: at admission
Pittsburgh sleep quality index（PSQI）is used to evaluate somnipathy
at admission
Tinnitus handicap inventory（THI）
Time Frame: at admission
Tinnitus handicap inventory（THI）is used to evaluate tinnitus cerebri
at admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Capital Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 14, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 19, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 19, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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