Trials / Not Yet Recruiting
Not Yet RecruitingNCT07072663
Glymphatic Function and White Matter Integrity in Cerebral Venous Disorders
Glymphatic Function and White Matter Integrity in Cerebral Venous Disorders: A Prospective Cohort Study
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 149 (estimated)
- Sponsor
- Xuanwu Hospital, Beijing · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Detailed description
Previously, researchers widely believed that the brain lacked a dedicated lymphatic system for clearing metabolic byproducts and wastes. However, recent studies have confirmed the existence of the glymphatic system along perivascular spaces (PVS), which plays a crucial role in metabolic waste clearance, nutrient and neuroactive substance exchange, regulation of central immune responses, and maintenance of cerebral fluid homeostasis. Emerging evidence suggests that dilated draining veins, elevated venous pressure, and increased intracranial pressure may impede glymphatic flow. Consequently, downstream venous pressure alterations-such as local stenosis or thrombosis in cerebral venous sinuses and/or internal jugular veins-could affect parenchymal venule pressure and volume, thereby influencing glymphatic system dynamics. Preserved myelin integrity is essential for maintaining synchronized and efficient interregional neural communication. Demyelination compromises brain network integration. Diffusion tensor imaging (DTI), an advanced magnetic resonance imaging (MRI) technique for assessing white matter microstructure, can sensitively detect integrity changes. Our preliminary studies identified characteristic bilateral symmetrical cloudy white matter alterations in patients with cerebral venous sinus stenosis, predominantly in periventricular and centrum semiovale regions. However, the precise pathological mechanism remains unclear, and direct evidence linking these changes to chronic venous outflow obstruction is lacking. Although similar imaging findings have not been reported in cerebral venous thrombosis patients, DTI may reveal early microstructural damage, suggesting potential pathological connections. White matter tracts serve not only as anatomical pathways for glymphatic flow but also depend on glymphatic clearance for metabolic homeostasis. This establishes a bidirectional regulatory relationship: glymphatic dysfunction may induce white matter injury, while white matter lesions could exacerbate glymphatic obstruction. Research indicates that glymphatic impairment may closely correlate with declining white matter integrity, with both potentially forming a mutually reinforcing feedback loop in disease progression across multiple pathologies. Therefore, this prospective cohort study aims to systematically evaluate glymphatic function and white matter integrity in cerebral venous diseases (including cerebral venous sinus stenosis and thrombosis), further exploring multidimensional correlations among clinical parameters, glymphatic activity, and white matter integrity. The findings may elucidate potential mechanisms of venous-related neural injury.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | 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. |
| OTHER | 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. |
Timeline
- Start date
- 2025-07-01
- Primary completion
- 2026-07-01
- Completion
- 2026-10-01
- First posted
- 2025-07-18
- Last updated
- 2025-07-18
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT07072663. Inclusion in this directory is not an endorsement.