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Observational
Glymphatic Function and White Matter Integrity in Cerebral Venous Disorders
Condition(s) studied
Cerebral Venous Sinus Thrombosis
Investigational drug(s) / intervention(s)
Baseline and 3-month follow-upBaseline
Baseline and 3-month follow-up: 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: 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.
Study summary
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
1. Subjects with Cerebral Venous Sinus Stenosis
Inclusion Criteria:
* 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;
* The subject or their legal representative signs a written informed consent form.
Exclusion Criteria:
* 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;
* History of cerebral infarction, cerebral hemorrhage, or neurosurgery;
* Complicated by other neurological structural abnormalities such as cerebral small vessel disease, intracranial vascular malformation, dural arteriovenous fistula, intracranial infection, intracranial space-occupying lesion, severe cerebral atrophy, or hydrocephalus;
* Presence of other diseases affecting glymphatic function (e.g., multiple sclerosis, neuromyelitis optica spectrum disorders, systemic lupus erythematosus, obstructive sleep apnea-hypopnea syndrome, Parkinson's disease, or Alzheimer's disease);
* Contraindications to MRI (e.g., metal implants, claustrophobia, etc.) or allergy to gadolinium-based contrast agents;
* Other conditions deemed unsuitable for enrollment by the investigator.
2. Subjects with Cerebral Venous Sinus Thrombosis
Inclusion Criteria:
* Age ≥18 years, any gender;
* Definite diagnosis of acute or subacute phase (onset to diagnosis ≤28 days) cerebral venous sinus thrombosis, with or without internal jugular vein thrombosis, confirmed by clinical and imaging examinations;
* The subject or their legal representative signs a written informed consent form.
Exclusion Criteria:
* Isolated cortical vein thrombosis or isolated cavernous sinus thrombosis;
* Recurrent intracranial venous sinus thrombosis;
* Complicated by venous cerebral infarction;
* 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;
* History of cerebral infarction, cerebral hemorrhage, or neurosurgery;
* Complicated by other neurological structural abnormalities such as cerebral small vessel disease, intracranial vascular malformation, dural arteriovenous fistula, intracranial infection, intracranial space-occupying lesion, severe cerebral atrophy, or hydrocephalus;
* Presence of other diseases affecting glymphatic function (e.g., multiple sclerosis, neuromyelitis optica spectrum disorders, systemic lupus erythematosus, obstructive sleep apnea-hypopnea syndrome, Parkinson's disease, or Alzheimer's disease);
* Presence of severe impaired consciousness, hearing impairment, or aphasia preventing cooperation with examinations or assessments;
* Contraindications to MRI (e.g., metal implants, claustrophobia, etc.) or allergy to gadolinium-based contrast agents;
* Other conditions deemed unsuitable for enrollment by the investigator.
3. Healthy Control Subjects:
Inclusion Criteria:
* Gender and age-matched;
* No central nervous system diseases;
* Normal scores on the HAMD-24, HAMA-14, MMSE, MoCA, and PSQI scales;
* No cerebral venous sinus thrombosis, cerebral venous sinus stenosis, or moderate to severe intracranial/extracranial arterial stenosis;
* No contraindications to MRI (e.g., metal implants, claustrophobia, etc.);
* The subject or their legal representative signs a written informed consent form.
Primary outcome measure(s)
- Change in DTI-ALPS index from baseline — day 90 (±14) post-enrollment
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.
Trial sites (1)
| Facility | City | Region | Status |
|---|
| Xuanwu Hospital, Capital Medical University |
Beijing |
China |
|
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