Cerebral Venous Sinus ThrombosisNCT07072663
Glymphatic Function and White Matter Integrity in Cerebral Venous Disorders
An observational study of Cerebral Venous Sinus Thrombosis, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cerebral Venous Sinus Thrombosis
- What is being tested?
- Baseline and 3-month follow-up and Baseline
- How many people
- 149 participants
- Where
- 1 siteChina
- Study dates
- Jul 2025to Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
- 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;
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- The subject or their legal representative signs a written informed consent form.
- 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.
Who cannot join
- 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;
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- 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.
- Subjects with Cerebral Venous Sinus Thrombosis
- 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.
- Healthy Control Subjects:
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Xuanwu Hospital, Capital Medical University
Beijing
Shuling Wan, +8615901589718, 15901589718@163.com
About this study
Official title: Glymphatic Function and White Matter Integrity in Cerebral Venous Disorders: A Prospective Cohort Study
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.
Read the 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
- Cerebral Venous Sinus Thrombosis
- Being tested
- Baseline and 3-month follow-up, Baseline
- Keywords
- cerebral venous sinus thrombosis, cerebral venous sinus stenosis, glymphatic system, white matter integrity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baseline and 3-month follow-upOther
At baseline and day 90 (±14) post-enrollment:
- Collect clinical data;
- Administer multiple scales to assess clinical symptom severity and neuropsychological status;
- Perform cranial diffusion tensor imaging (DTI) to evaluate glymphatic function and white matter integrity;
- Collect peripheral blood and cerebrospinal fluid (CSF) samples for biomarker level analysis.
BaselineOther
At baseline:
- Collect clinical data;
- Assess intracranial and extracranial arterial and venous systems;
- Administer multiple scales to assess neuropsychological status;
- Perform cranial diffusion tensor imaging (DTI) to evaluate glymphatic function and white matter integrity;
- Collect peripheral blood samples for biomarker level analysis.
| Study group | Role | What they receive |
|---|---|---|
| HC group | Sex- and age-matched healthy controls (HCs) without cerebral venous sinus thrombosis (CVST), cerebral venous sinus stenosis (CVSS), or moderate-to-severe intracranial/extracranial arterial stenosis. Receives: Other: Baseline | |
| CVSS group | Subjects aged ≥18 years with confirmed cerebral venous sinus stenosis (CVSS) exclusively involving the transverse sinus and/or sigmoid sinus (stenosis ≥50%), with or without concomitant internal jugular vein stenosis. Receives: Other: Baseline and 3-month follow-up | |
| CVST group | Subjects aged ≥18 years with confirmed acute/subacute cerebral venous sinus thrombosis (CVST) (time from onset to diagnosis ≤28 days), with or without concomitant internal jugular vein thrombosis. Receives: Other: Baseline and 3-month follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: day 90 (±14) post-enrollment
Secondary outcomes (28)
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.
Measured: day 90 (±14) post-enrollment
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.
Measured: day 90 (±14) post-enrollment
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.
Measured: day 90 (±14) post-enrollment
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.
Measured: day 90 (±14) post-enrollment
Change in FA from baseline
Fractional anisotropy (FA) is obtained by Diffusion Tensor Imaging (DTI), and decreased FA values indicate white matter damage.
Measured: day 90 (±14) post-enrollment
Change in MD from baseline
Mean diffusivity (MD) is obtained by Diffusion Tensor Imaging (DTI), and increased MD values indicate white matter damage.
Measured: day 90 (±14) post-enrollment
Change in RD from baseline
Radial diffusivity (RD) is obtained by Diffusion Tensor Imaging (DTI), and increased RD values indicate white matter damage.
Measured: day 90 (±14) post-enrollment
Change in AD from baseline
Axial diffusivity (AD) is obtained by Diffusion Tensor Imaging (DTI), and increased RD values indicate white matter damage.
Measured: day 90 (±14) post-enrollment
Change in headache VAS score from baseline
The visual analogue scale (VAS) for headache assesses pain intensity on a 0-10 scale, where higher scores correlate with greater headache severity.
Measured: day 90 (±14) post-enrollment
Change in HIT-6 score from baseline
Headache Impact Test-6 (HIT-6) is used to assess the comprehensive impact of headaches on quality of life, with total scores ranging from 36 to 78 points. Higher scores indicate greater disruption to daily functioning.
Measured: day 90 (±14) post-enrollment
Change in tinnitus VAS score from baseline
The visual analogue scale (VAS) for tinnitus assesses symptom severity on a 0-10 scale, where higher scores indicate more severe tinnitus.
Measured: day 90 (±14) post-enrollment
Change in THI score from baseline
The tinnitus handicap inventory (THI) is used to evaluate the impact of tinnitus on quality of life, with total scores ranging from 0 to 100. Higher scores reflect more severe disruption to daily functioning.
Measured: day 90 (±14) post-enrollment
Change in head noise VAS score from baseline
The visual analogue scale (VAS) for head noise assesses symptom severity on a 0-10 scale, where higher scores indicate more severe head noise.
Measured: day 90 (±14) post-enrollment
Change in HNHI score from baseline
Head noise handicap inventory (HNHI) is adapted from the tinnitus handicap inventory (THI) by systematically replacing "tinnitus" with "head noise" to evaluate the impact of head noise on quality of life. Total scores range from 0-100, with higher values reflecting more severe functional impairment.
Measured: day 90 (±14) post-enrollment
Change in mRS score from baseline
Modified Rankin Scale (mRS) is used to assess neurological functional recovery status, with total scores ranging from 0 to 6. Higher scores indicate more severe neurological impairment and worse independent living capacity.
Measured: day 90 (±14) post-enrollment
Change in HAMD-24 score from baseline
The 24-item Hamilton Depression Rating Scale (HAMD-24) is used to quantitatively assess the severity of depressive symptoms, with total scores ranging from 0 to 76. Higher scores indicate more severe depression.
Measured: day 90 (±14) post-enrollment
Change in HAMA-14 score from baseline
The 14-item Hamilton Anxiety Rating Scale (HAMA-14) is used to quantitatively assess the severity of anxiety symptoms, with total scores ranging from 0 to 56. Higher scores indicate more severe anxiety.
Measured: day 90 (±14) post-enrollment
Change in MMSE score from baseline
The Mini-Mental State Examination (MMSE) is used to assess cognitive function, with total scores ranging from 0 to 30. Lower scores indicate more severe cognitive impairment.
Measured: day 90 (±14) post-enrollment
Change in MoCA score from baseline
The Montreal Cognitive Assessment (MoCA) is used to assess cognitive function, with total scores ranging from 0 to 30. Lower scores indicate more severe cognitive impairment.
Measured: day 90 (±14) post-enrollment
Change in PSQI score from baseline
The Pittsburgh Sleep Quality Index (PSQI) is used to assess sleep quality, with total scores ranging from 0 to 21 points. A score >5 points indicates sleep disturbance.
Measured: day 90 (±14) post-enrollment
Change in fundus parameters from baseline
Fundus parameters include modified Frisen grading of the fundus, optic disc height, optic nerve sheath width, average retinal nerve fiber layer (RNFL) thickness, etc. These parameters to some extent reflect the degree of intracranial pressure.
Measured: day 90 (±14) post-enrollment
Change in lumbar puncture opening pressure from baseline
The normal lumbar puncture opening pressure range for adults is 70-180 mmH₂O. A pressure >200 mmH₂O typically indicates elevated intracranial pressure.
Measured: day 90 (±14) post-enrollment
Change in Farb score from baseline
The Farb Score is used to evaluate the degree of venous sinus stenosis in subjects with cerebral venous sinus stenosis. The total score ranges from 0 to 8 points, with lower scores indicating higher degrees of stenosis.
Measured: day 90 (±14) post-enrollment
Change in thrombus burden from baseline
The thrombus burden is measured semi-automatically using ITK-SNAP software on contrast-enhanced black-blood thrombus imaging of the head and neck veins.
Measured: day 90 (±14) post-enrollment
Venous sinus recanalization rate
A three-tier classification based on contrast-enhanced MRV of the head and neck is used to evaluate venous sinus recanalization.
Measured: day 90 (±14) post-enrollment
Change in biomarker levels in blood and cerebrospinal fluid from baseline
Blood and cerebrospinal fluid biomarkers include AQP4, Glial Fibrillary Acidic Protein (GFAP), Neurofilament Light Chain (NfL), Aβ40/42, total tau protein (Tau), phosphorylated tau181 (p-Tau181), interleukin (IL)-1β, IL-6, IL-8, IL-10, and tumor necrosis factor (TNF-α).
Measured: day 90 (±14) post-enrollment
Incidence of adverse events
Adverse events included bleeding complications, major bleeding complications (hemoglobin drop ≥19 g/L), symptomatic intracranial hemorrhage, among others.
Measured: day 90 (±14) post-enrollment
All-cause mortality
All-cause mortality refers to deaths from any cause within a studied population, regardless of the specific reason.
Measured: day 90 (±14) post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study startJul 2025 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Venous Sinus ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 149 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Da Zhou, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07072663
- Sponsor's protocol ID
- LYS[2025]216-002
- Status last verified
- Jul 2025
- First submitted
- 9 Jul 2025
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glymphatic Function and White Matter Integrity in Cerebral Venous Disorders: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07072663
- Acronym / sponsor ID
- LYS[2025]216-002
- Conditions
- Cerebral Venous Sinus Thrombosis
- Keywords
- cerebral venous sinus thrombosis, cerebral venous sinus stenosis, glymphatic system, white matter integrity
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 149 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 18 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HC group | – | Other: BaselineSex- and age-matched healthy controls (HCs) without cerebral venous sinus thrombosis (CVST), cerebral venous sinus stenosis (CVSS), or moderate-to-severe intracranial/extracranial arterial stenosis. |
| CVSS group | – | Other: Baseline and 3-month follow-upSubjects aged ≥18 years with confirmed cerebral venous sinus stenosis (CVSS) exclusively involving the transverse sinus and/or sigmoid sinus (stenosis ≥50%), with or without concomitant internal jugular vein stenosis. |
| CVST group | – | Other: Baseline and 3-month follow-upSubjects aged ≥18 years with confirmed acute/subacute cerebral venous sinus thrombosis (CVST) (time from onset to diagnosis ≤28 days), with or without concomitant internal jugular vein thrombosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (13 listed)
- 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.);
Key exclusion criteria (22 listed)
- Subjects with Cerebral Venous Sinus Thrombosis
- Healthy Control Subjects:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baseline and 3-month follow-upAt 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 | CVSS group, CVST group |
| BaselineAt 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. | Other | HC group |
Primary outcome
Change in DTI-ALPS index from baseline
Time frame: 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.
28 secondary outcomes
Change in PVS score from baseline
Time frame: day 90 (±14) post-enrollment
Change in PVS count from baseline
Time frame: day 90 (±14) post-enrollment
Change in PVS volume from baseline
Time frame: day 90 (±14) post-enrollment
Change in CPV from baseline
Time frame: day 90 (±14) post-enrollment
Change in FA from baseline
Time frame: day 90 (±14) post-enrollment
Change in MD from baseline
Time frame: day 90 (±14) post-enrollment
Change in RD from baseline
Time frame: day 90 (±14) post-enrollment
Change in AD from baseline
Time frame: day 90 (±14) post-enrollment
Change in headache VAS score from baseline
Time frame: day 90 (±14) post-enrollment
Change in HIT-6 score from baseline
Time frame: day 90 (±14) post-enrollment
Change in tinnitus VAS score from baseline
Time frame: day 90 (±14) post-enrollment
Change in THI score from baseline
Time frame: day 90 (±14) post-enrollment
Change in head noise VAS score from baseline
Time frame: day 90 (±14) post-enrollment
Change in HNHI score from baseline
Time frame: day 90 (±14) post-enrollment
Change in mRS score from baseline
Time frame: day 90 (±14) post-enrollment
Change in HAMD-24 score from baseline
Time frame: day 90 (±14) post-enrollment
Change in HAMA-14 score from baseline
Time frame: day 90 (±14) post-enrollment
Change in MMSE score from baseline
Time frame: day 90 (±14) post-enrollment
Change in MoCA score from baseline
Time frame: day 90 (±14) post-enrollment
Change in PSQI score from baseline
Time frame: day 90 (±14) post-enrollment
Change in fundus parameters from baseline
Time frame: day 90 (±14) post-enrollment
Change in lumbar puncture opening pressure from baseline
Time frame: day 90 (±14) post-enrollment
Change in Farb score from baseline
Time frame: day 90 (±14) post-enrollment
Change in thrombus burden from baseline
Time frame: day 90 (±14) post-enrollment
Venous sinus recanalization rate
Time frame: day 90 (±14) post-enrollment
Change in biomarker levels in blood and cerebrospinal fluid from baseline
Time frame: day 90 (±14) post-enrollment
Incidence of adverse events
Time frame: day 90 (±14) post-enrollment
All-cause mortality
Time frame: day 90 (±14) post-enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Da Zhou principal investigator
Xuanwu Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Venous Sinus Thrombosis, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shuling Wan (+8615901589718, 15901589718@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in DTI-ALPS index from baseline (time frame: day 90 (±14) post-enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.