Glymphatic Function and White Matter Integrity in Cerebral Venous Disorders

NCT07072663 | Not Yet Recruiting

• 1 other identifier: LYS[2025]216-002
• Study Type: observational
• Target: 149
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cerebral Venous Sinus Thrombosis

Keywords

cerebral venous sinus thrombosis; cerebral venous sinus stenosis; glymphatic system; white matter integrity

Outcome Measures

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.

  day 90 (±14) post-enrollment

Secondary Outcomes (28)

• Change in PVS score from baseline

  day 90 (±14) post-enrollment

• Change in PVS count from baseline

  day 90 (±14) post-enrollment

• Change in PVS volume from baseline

  day 90 (±14) post-enrollment

• Change in CPV from baseline

  day 90 (±14) post-enrollment

• Change in FA from baseline

  day 90 (±14) post-enrollment

Study Arms (3)

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.

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.

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.

Other: Baseline and 3-month follow-up

Interventions

Baseline and 3-month follow-up OTHER

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.

CVSS group; CVST group

Baseline OTHER

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.

HC group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Subjects with Cerebral Venous Sinus Thrombosis
• 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.
• Isolated cortical vein thrombosis or isolated cavernous sinus thrombosis;
• Recurrent intracranial venous sinus thrombosis;

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

In this study, blood and/or cerebrospinal fluid (CSF) samples will be collected from participants. Prior to collection, informed consent should be obtained.

MeSH Terms

Interventions

BaseLine dental cement

Study Officials

• Da Zhou

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shuling Wan

CONTACT

+8615901589718; 15901589718@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: July 18, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)