Effect of Vagus Nerve Stimulation on Improving Vasomodulatory and Cognitive Function in Patients with Cerebral Small Vessel Diseases

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200056313

Enrollment

Unknown

Registered

2022-02-03

Start date

2022-04-27

Completion date

Unknown

Last updated

2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral small vessel disease

Interventions

Vagus nerve stimulation group:Conventional treatment + physical intervention + lifestyle intervention

Control group:Routine care

Vagus nerve stimulation group:Conventional treatment + lifestyle intervention

Eligibility

Sex/Gender

All

Age

45 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged 45 years and over; 2. Presence of CSVD markers on MRI, shows any of the following: (1) White matter hyperintensities, Fazekas score >= 2; (2) Fazekas = 1 with >= 2 vascular risk factors (hypertension, hyperlipidemia, diabetes, obesity, current smoking, past medical history of vascular events except stroke); (3) Fazekas = 1 with lacuna; (4) Recent subcortical lacunar infarction based upon imaging; 3. HRV high frequency parameter < 100 ms2; 4. MoCA < 26; 5. Independent in activities of daily life (mRS <= 2); 6. Provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. Acute cerebral infarction or acute cerebral hemorrhage; 2. Acute subarachnoid hemorrhage or previous history of cerebrovascular malformation, aneurysmal subarachnoid hemorrhage or untreated aneurysms (> 3mm in diameter); 3. Diagnosed neurodegenerative diseases; 4. Presence of non-vascular white matter lesions, e.g.multiple sclerosis and metabolic encephalopathy; 5. Frequent arrhythmia or taking drugs affecting autonomic nerve function; 6. Diagnosis of mental disorder; 7. Uneducated; 8. Contraindications of Magnetic Resonance Imaging examination (e.g. claustrophobia.); 9. Severe organic disease, such as malignant tumor, with a life expectancy less than 2 years; 10. Unable to follow up due to geographical or other reasons; 11. Participate in other clinical trials at the same time.

Design outcomes

Primary

Measure	Time frame
Heart rate variability;Cognitive function;Brain MRI;	—

Secondary

Measure	Time frame
Vasoregulatory function;Brainwave status;Emotional state;Sleep;Cerebrovascular reactivity;Neurovascular coupling;Gait;	—

Countries

China

Contacts

Public ContactWang Yilong

Beijing Tiantan Hospital affiliated to Capital Medical University

yilongwang528@163.com+86 13911666571

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026