About this trial
Cerebral venous disorders, including cerebral venous sinus stenosis (CVSS) and cerebral venous sinus thrombosis (CVST), can obstruct venous blood drainage, leading to intracranial hypertension. However, their effects on glymphatic function and white matter integrity in the brain remain poorly understood.
Therefore, this study will enroll healthy controls, CVSS patients, and CVST patients to compare differences in glymphatic function and white matter microstructural integrity. Additionally, CVSS and CVST patients will undergo a 3-month follow-up to investigate the interrelationships and longitudinal changes among clinical parameters, glymphatic function, and white matter integrity.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Subjects with Cerebral Venous Sinus Stenosis
Age ≥18 years, any gender;
Definite diagnosis of cerebral venous sinus stenosis confirmed by clinical and imaging examinations;
Stenosis limited to the transverse sinus and/or sigmoid sinus, presenting as moderate to severe localized stenosis or occlusion (stenosis degree ≥50%), with or without internal jugular vein stenosis;
Disqualifiers
Simple anatomical variation or physiological narrowing of the cerebral venous sinus/internal jugular vein without definitive evidence of localized stenosis;
Complicated by cerebral venous sinus/cortical vein/internal jugular vein thrombosis;
Prior receipt of endovascular treatment for cerebral venous sinus/internal jugular vein, ventricular puncture drainage, or lumbar cistern drainage before enrollment;
Presence of moderate to severe stenosis (≥50%) in intracranial or extracranial arteries;
Trial population
Subjects with cerebral venous sinus stenosis (CVSS) and cerebral venous sinus thrombosis (CVST) will be recruited from the outpatient clinic or inpatient wards of the Department of Neurology at Xuanwu Hospital, Capital Medical University, while healthy controls will be recruited from health examination centers or the community.
Trial design
Cohort
Prospective
Treatments tested in this trial
Baseline and 3-month follow-up
Other interventionAt baseline and day 90 (±14) post-enrollment: 1. Collect clinical data; 2. Administer multiple scales to assess clinical symptom severity and neuropsychological status; 3. Perform cranial diffusion tensor imaging (DTI) to evaluate glymphatic function and white matter integrity; 4. Collect peripheral blood and cerebrospinal fluid (CSF) samples for biomarker level analysis.
Baseline
Other interventionAt baseline: 1. Collect clinical data; 2. Assess intracranial and extracranial arterial and venous systems; 3. Administer multiple scales to assess neuropsychological status; 4. Perform cranial diffusion tensor imaging (DTI) to evaluate glymphatic function and white matter integrity; 5. Collect peripheral blood samples for biomarker level analysis.
Treatment groups
Trial outcomes
Primary outcomes
Change in DTI-ALPS index from baseline
The DTI-ALPS (Diffusion Tensor Imaging-Analysis along Perivascular Spaces) index is an imaging biomarker that quantitatively evaluates the function of the brain's glymphatic system using diffusion tensor imaging (DTI) technology, with lower values indicating impaired glymphatic clearance.
Secondary outcomes
Change in PVS score from baseline
Perivascular spaces (PVS) in the basal ganglia (BG) and centrum semiovale (CSO) are visually scored as: 0 = none, 1 = 1-10, 2 = 11-20, 3 = 21-40, and 4 = \>40 on the axial slice with the highest burden and hemicerebrum with higher burden. An increase in PVS score implies a decrease in glymphatic function.
Change in PVS count from baseline
The number of PVS in the whole brain will be automatically calculated using deep learning algorithms. An increase in PVS count implies a decrease in glymphatic function.
Change in PVS volume from baseline
The volume of PVS in the whole brain will be automatically calculated using deep learning algorithms. An increase in PVS volume implies a decrease in glymphatic function.
Change in CPV from baseline
The choroid plexus volume (CPV) will be automatically segmented and calculated using Freesurfer software. An increase in CPV implies a decrease in glymphatic function.
Sponsors and contacts
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