Intermittent Theta Burst Stimulation on Cognitive Impairment of Cerebral Small Vessel Disease

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Cerebral Small Vessel Diseases, Cognitive Impairment

In brief

The cerebral small vessel diseases (CVSD) can cause severe and lasting damage to cognition function while the current available treatment of vascular cognitive impairment (VCI) is limited. The purpose of this study is to explore the feasibility, safety, and efficacy of intermittent Theta Burst Stimulation (iTBS) on cognitive impairment of cerebral small vessel disease.

Key facts

Study ID

NCT06579664

Run by

Beijing Tiantan Hospital

People needed

58

Starts

2025-03-24

Expected to finish

2026-12-31

Last updated by the study team

2025-09-08

Who can join

Age: 45 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• History of stroke within previous 30 days, including cerebral infarction (diameter >15mm), cerebral hemorrhage, subarachnoid hemorrhage;
• History of cerebral cortex infarction.
• History of cerebrovascular malformation or aneurysmal subarachnoid hemorrhage, or discovery of an untreated aneurysm > 3mm.
• Carotid or vertebral artery stenosis > 50% measured on North American Symptomatic Carotid Endarterectomy Trial (NASCET) criteria.
• Possible amyloid cerebrovascular disease with at least 2 lobar hemorrhagic lesions (i.e., intracranial hemorrhage, cerebral microbleeds (CMB), cortical superficial siderosis, or convexal subarachnoid hemorrhage) measured on Boston Criteria 2.0; Or at least one lobar hemorrhagic lesion and at least one white matter feature (severe enlarged perivascular space in the centrum semiovale or multiple punctate white matter hyperintensities) without deep hemorrhagic lesion (cerebral hemorrhage or CMB) on T2* weighted MRI.
• Recorded diagnosis of neurodegenerative diseases (e.g. Alzheimer's disease and Parkinson's disease).
• Definite non-vasogenic white matter lesions (e.g. multiple sclerosis, cortical dysplasia in adults, metabolic encephalopathy).
• Other psychiatric disorders diagnosed measured on the Diagnostic and Statistical Manual of Mental Disorders - V (DSM-V) diagnostic criteria; Or apparent suicidal intent.
• Unable to tolerate MRI or contraindication to MRI (e.g., claustrophobia).
• T1 or T2 weighted MRI shows focal brain injury.
• Patients or first-degree relatives with a history of seizures.
• Implanted pacemakers, vagus nerve stimulators, deep brain stimulators, or other metal medical devices.
• Received transcranial magnetic stimulation therapy within previous 3 months.
• Severe organic diseases with expected survival time <5 years, such as malignant tumor.
• Women of child bearing potential, pregnant or breastfeeding.
• Individual who have difficulty communicating verbally to the extent that they are unable to communicate, understand or follow instructions normally, and are unable to cooperate with treatment and evaluation.
• Combined with alcohol and drug abuse history.
• Unable to be cooperative and complete the follow-up due to geographical or other reasons.
• Participated in other clinical trials.

Where it is running

• Beijing Tiantan Hospital — Beijing, China (enrolling)

Full record on ClinicalTrials.gov

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