Clinical trial NCT05820165: Brain Imaging in Cerebral Venous Outflow Disturbance
Official title: Study on Brain Structure and Function Imaging in Patients With Cerebral Venous Outflow Disturbance
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Abnormal Cerebral Venous Sinus Morphology
Internal Jugular Vein Stenosis
Image
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2023-04-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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 )

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: voxel-based morphometry
timeFrame: at admission
Secondary outcomes:
measure: The amplitude of low-frequency fluctuations (ALFF)
timeFrame: at admission
Other outcomes:
measure: Regional homogeneity (ReHo)
timeFrame: at admission
measure: Voxel-wise functional connectivity (FC)
timeFrame: at admission
measure: Tract-based spatial statistics (TBSS) analysis
timeFrame: at admission
measure: Mini-Mental State Examination(MMSE)
timeFrame: at admission
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: at admission
measure: Subjective Cognitive Decline（SCD）
timeFrame: at admission
measure: Self-Rating Anxiety Scale（SAS）
timeFrame: at admission
measure: Self-rating depression scale（SDS）
timeFrame: at admission
measure: Pittsburgh sleep quality index（PSQI）
timeFrame: at admission
measure: Tinnitus handicap inventory（THI）
timeFrame: at admission
Locations:
city: Beijin
country: China
facility: Xuanwu hospital;Capital Medical University
state: XI Cheng District
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Xunming Ji, MD.PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.