Glymphatic Function and White Matter Integrity in Cerebral Venous Disorders

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorXuanwu Hospital, Beijing

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Baseline and 3-month follow-up

    Other intervention

    At 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 intervention

    At 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

149 Participants
are divided into 3 treatment groups
Group A: HC group1 intervention
Group B: CVSS group1 intervention
Group C: CVST group1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
day 90 (±14) post-enrollment

Secondary outcomes

1

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.

Time frame
day 90 (±14) post-enrollment
2

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.

Time frame
day 90 (±14) post-enrollment
3

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.

Time frame
day 90 (±14) post-enrollment
4

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.

Time frame
day 90 (±14) post-enrollment

Other outcomes

Sponsors and contacts

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