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RecruitingNCT05715710Updated Jan 28, 2025

Correlation Between Deep Medullary Veins and Cognitive Dysfunction in Cerebral Small Vessel Disease

An observational study in Cerebral Small Vessel Disease, sponsored by Zigong No.1 Peoples Hospital. Recruiting at 1 site in China. Open to participants aged 50 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-28.

Sponsored by Zigong No.1 Peoples Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started Jan 2022; still recruiting 4 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
50 Years to 85 Years
Sex
All
01

Study summary

This study aims to obtain the characteristics of cognitive impairment and imaging characteristics of patients with Cerebral small vessel disease (CSVD) through comprehensive and standardized neuropsychological assessment and multimodal imaging examination. The focus is to obtain the characteristics of cognitive impairment and imaging characteristics of patients with CSVD through 3.0T MRI SWI sequence. deep medullary veins (DMVs) were measured. To compare the demographic data, hematological indexes, imaging scores and the number of DMVs between CSVD groups with and without cognitive impairment, and to explore the correlation between deep medullary veins and cognitive dysfunction in cerebral small vessel disease.

Read the detailed description

This study aims to obtain the characteristics of cognitive impairment and imaging characteristics of patients with Cerebral small vessel disease (CSVD) by conducting comprehensive and standardized neuropsychological assessment and multimodal imaging examination. deep medullary veins (DMVs) were measured. The demographic data, hematological indexes, imaging scores and the number of DMVs were compared between the CSVD group with and without cognitive impairment, and the risk factors for cognitive impairment in CSVD were analyzed to explore whether DMVs could be an independent risk factor for cognitive impairment in CSVD. To establish a multiple model for the risk prediction of cognitive impairment in CSVD, and to understand whether the prediction model combined with the number of DMVs has a better prediction effect on cognitive impairment in CSVD. In order to find new imaging markers of cognitive impairment in CSVD, and provide evidence for early detection and intervention of cognitive impairment in clinical CSVD.

02

Conditions studied

  • Cerebral Small Vessel Disease

Keywords

  • deep medullary veins
  • csvd
  • cerebral small vessel disease
03

In context

Cerebral Small Vessel Diseases

121 studies on the registry are indexed under Cerebral Small Vessel Diseases; 66 are open to participants now.

This study's planned enrollment of 200 is below the median of 300 across 52 observational studies indexed under Cerebral Small Vessel Diseases.

Browse Cerebral Small Vessel Diseases studies →

Lead sponsor

Zigong No.1 Peoples Hospital is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

  1. CSVD patients who met the inclusion and exclusion criteria were included. Demographic data, cerebrovascular disease risk factors data, and hematological data were collected.
  2. Standardized neuropsychological assessment was performed to evaluate the general cognition and various cognitive domains (memory, language, visuospatial execution) of CSVD patients.
  3. Fazekas score of white matter hyperintensity (WMH) and cerebral microbleed (cerebral microbleed) were calculated based on the results of 3.0 T multimode MRI examination. CMB count, lacunar infarction count, perivascular space (PVS) count, and MRI total load score; Deep medullary veins (DMVs) were counted by SWI sequence.

Inclusion criteria

  1. Age 50 \~ 85 years old.

    1. The diagnostic criteria of CSVD patients with cerebral small vessel diseases should be in accordance with the 2015 Chinese Consensus on the diagnosis and treatment of cerebral small vessel Diseases formulated and recommended by the Cerebrovascular Division of Chinese Society of Neurology, Chinese Medical Association. MRI examination revealed the presence of one or more of the major imaging features of CSVD as proposed by the 2013 International Standards Reporting Group on Neuroimaging of Vascular Changes.
    2. No large vessel stenosis (stenosis rate > 50%) was found after head and neck vascular examination (CTA, MRA, DSA or TCD combined with carotid ultrasound).
    3. The vital signs are stable and can cooperate with the examination.
    4. Informed consent signed by the patient or legal representative.

Exclusion criteria

  1. Cerebral infarction or cerebral hemorrhage caused by large vascular disease; And CTA/MRA of the head and neck showed great vessel stenosis (stenosis rate > 50%).

    1. Patients with secondary white matter lesions caused by poisoning, inflammation, tumor and other pathological changes.
    2. Cognitive impairment and gait impairment caused by other causes (such as Alzheimer's disease, Parkinson's disease, depression, etc.
    3. Patients with contraindications of magnetic resonance examination.
    4. Illiterate or unable to cooperate with cognitive assessment due to severe hearing and visual impairment.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Deep medullary veins score

    In this study, deep medullary veins (DMVs) were counted by SWI sequence.

    Time frame: 2022.01-2025.1

07

Study locations

1 of 1 sites recruiting
  • Zigong First People's Hospital
    Zigong, Sichuan 643000, China
    • ya x Xu · Contact · 502687651@qq.com · 15983171312
    • ya x Xu · Contact
    • Ling Zhao · Contact
    • Jing Yang · Contact
    • Hui Li · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05715710
Lead sponsor
Zigong No.1 Peoples Hospital
Responsible party
Sponsor
First posted
Feb 8, 2023
Start date
Jan 1, 2022
Primary completion
Dec 1, 2025 (estimated)
Completion
Dec 1, 2025 (estimated)
Last update
Jan 28, 2025

Study contacts

ya x Xu
Contact
502687651@qq.com
15983171312
ling zhao
Contact
1628583742@qq.com
13679076409
ya x Xu
principal investigator · Zigong No.1 People's Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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