Effect of Long-Term Head and Neck Venous Outflow Obstruction on Cognitive Function: Evidence From Patients With Internal Jugular Vein Stenosis
Long-Term Head and Neck Venous Outflow Obstruction and Cognitive Function: Evidence From Patients With Internal Jugular Vein Stenosis-A Case-Control Study Combined With a Prospective Observational Cohort Study
This study aims to determine the effect of long-term head and neck venous outflow obstruction-specifically internal jugular vein stenosis (IJVS) caused by atlas transverse process compression with a stenosis rate ≥50%-on cognitive function, and to observe the cognitive outcomes of atlas transverse process resection combined with release and perfusion technique in routine clinical care. The study uses a case-control design to compare cognitive function between patients with IJVS and matched healthy controls, and a prospective cohort design to follow surgical and non-surgical cohorts for 6 months. The Montreal Cognitive Assessment (MoCA) total score is the primary cognitive measure. The target population per the protocol summary is image-confirmed IJVS due to atlas transverse process compression (stenosis ≥50%), with mild-to-moderate cognitive impairment (MoCA <26), aged 18-65 years.
Study Overview
Status
Detailed Description
Internal jugular vein stenosis is an important cause of head and neck venous outflow obstruction, and extrinsic stenosis caused by bony compression of the atlas transverse process is common in clinical practice. Atlas transverse process decompression is currently used mainly to relieve somatic symptoms such as pulsatile tinnitus, headache, and dizziness; however, high-quality evidence on its systematic effect on cognitive function is lacking. This study is conducted within routine clinical care and does not add any additional invasive sampling or traumatic examinations. During standard management-surgical decompression or conservative treatment-cognitive function and imaging-based venous outflow indicators are observed longitudinally.
In the case-control component, patients with IJVS (disease duration ≥6 months) are matched 1:1 to healthy controls by age, sex, and years of education; MoCA total scores and cognitive subdomain scores are compared. In the cohort component, patients are assigned to a surgical cohort or a non-surgical cohort according to clinical indications and patient preference, without randomization or inducement. Follow-up is conducted at 1, 3, and 6 months after surgery or enrollment. The planned total cohort sample size is 72 participants (36 surgical and 36 non-surgical, allowing for a 10% dropout rate). Healthy controls for the case-control analysis are matched 1:1 and are not counted within the 72 cohort participants.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Zhiqiang Hu
- Phone Number: +8613144628367
- Email: neuro7@163.com
Study Contact Backup
- Name: Junpeng Xu
- Phone Number: +8613144628367
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Surgical cohort Procedure (routine clinical care, not a study intervention) Patients undergo atlas transverse process resection combined with release and perfusion technique according to clinical indications. The procedure aims to relieve bony compression of the internal jugular vein by the atlas transverse process. Postoperative follow-up is performed according to routine care. The study does not alter surgical indications or the operative procedure; it only observes changes in MoCA scores and imaging-based venous outflow indicators at 1, 3, and 6 months after surgery.
Healthy control group (case-control component) Observational comparator group Age-, sex-, and education-matched individuals without IJVS or head and neck venous outflow obstruction, matched 1:1 to the case group.
Description
Inclusion Criteria:
Cohort study (surgical cohort / non-surgical cohort):
Age 18-65 years, either sex. Confirmed by head and neck CT venography (CTV), MR venography (MRV), and jugular vein ultrasound as extrinsic IJVS caused by atlas transverse process compression, with a stenosis rate ≥50%.
Voluntary participation and signed written informed consent. Able to cooperate with MoCA cognitive assessment and related examinations at all scheduled time points.
No severe hepatic or renal insufficiency, coagulation disorders, or other severe underlying diseases.
Surgical cohort: no surgical contraindication and willingness to undergo atlas transverse process resection combined with release and perfusion technique. Non-surgical cohort: willingness to receive conservative treatment without surgery and no urgent surgical indication during follow-up.
Case-control study-case group:
Clinically confirmed IJVS with disease duration ≥6 months. CTV-confirmed IJVS caused by atlas transverse process compression. No history of previous cerebral infarction, intracranial hemorrhage, Alzheimer's disease, or other known causes of cognitive decline.
Complete baseline clinical and imaging data available.
Case-control study-healthy control group:
Age-, sex-, and education-matched individuals without IJVS, without head and neck venous outflow obstruction, and without severe organic disease or a history of cognitive impairment.
Exclusion Criteria
Cohort study:
Cognitive impairment caused by another definite etiology (e.g., Alzheimer's disease, cerebral infarction, cerebral hemorrhage, hypothyroidism).
Severe psychiatric disease preventing cooperation with cognitive assessment and study procedures.
Neck surgery, radiotherapy, or internal jugular vein intervention within the previous 3 months.
Pregnancy or breastfeeding. Malignant tumor, autoimmune disease, or other condition with an expected survival of less than 1 year.
Long-term use of sedative-hypnotics or cognitive-enhancing drugs that may affect MoCA assessment.
Refusal to participate in follow-up or inability to complete all scheduled assessments.
Case-control study:
Other imaging-detected venous abnormalities, such as venous sinus stenosis or jugular vein reflux, or the styloid process identified as the main compressive structure causing IJVS.
Severe heart failure or other major cardiac dysfunction. Severe hearing impairment or other conditions that may affect the validity or completion of cognitive assessment.
Intrathoracic or intracranial space-occupying lesions, cerebral vascular malformations, or other abnormalities on high-resolution chest CT, brain MRI, or CT that may constitute a major hemodynamic obstruction.
Study Plan
How is the study designed?
Design Details
- Observational Models: COHORT
- Time Perspectives: PROSPECTIVE
Cohorts and Interventions
Group / Cohort |
|---|
|
IJVS
Internal Jugular Vein Stenosis |
|
HC
healthy controls |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in MoCA total score
Time Frame: Baseline, 1 month, 3 months, and 6 months after surgery/follow-up
|
Change in the Montreal Cognitive Assessment total score from baseline to 6 months after surgery/follow-up. In the cohort component, between-group differences and repeated-measures trends are compared between the surgical and non-surgical cohorts. In the case-control component, baseline differences between cases and healthy controls are compared. |
Baseline, 1 month, 3 months, and 6 months after surgery/follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
IJV stenosis improvement rate
Time Frame: Baseline, 1, 3, and 6 months after surgery/follow-up
|
Imaging-based quantitative assessment of improvement in IJVS severity by CTV/ultrasound. |
Baseline, 1, 3, and 6 months after surgery/follow-up
|
|
Head and neck venous outflow patency
Time Frame: Baseline, 1, 3, and 6 months
|
CTV/MRV assessment of venous sinus morphology, patency, and collateral circulation; ultrasound assessment of blood flow velocity and reflux. |
Baseline, 1, 3, and 6 months
|
|
Incidence of postoperative complications/adverse events
Time Frame: Intraoperative period through 6-month follow-up
|
Bleeding, infection, hematoma, nerve stimulation, venous thrombosis, contrast agent reactions, etc. |
Intraoperative period through 6-month follow-up
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BJSJTYY-IJVS-COG-2026
- IIT2026-063-001 (Other Identifier: Ethics approval number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
We do not plan to share individual participant data (IPD). This is due to the strict requirements of the Personal Information Protection Law of the People's Republic of China and the local Ethics Committee regarding the protection of patient privacy and medical data, as the participants did not explicitly provide consent for public data sharing at the time of enrollment.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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