Intermittent Theta Burst Stimulation on Cognitive Impairment of Cerebral Small Vessel Disease
Beijing Tiantan Hospital
58 participants
Mar 24, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria7
- Age 45-80 years old, with no limitation on sex.
- Clinical evidence of CVSD as evidenced by one or more of:
- White matter hyperintensity with Fazekas score ≥2
- a lacunar stroke syndrome (e.g. pure motor stroke, pure sensory stroke, sensorimotor stroke, ataxic hemiparesis, or clumsy hand dysarthria syndrome) with a corresponding acute lacunar infarct on diffusion weighted imaging (DWl) for cases imaged (clinically) within 3 weeks of stroke or anatomically compatible lacunar infarct on fluid attenuated inversion recovery (FLAIR)/T1 MRI for cases imaged later after stroke (diameter≤1.5cm).
- Independence of daily life (modified Rankin Scale score ≤2).
- Mild vascular cognitive impairment (memory and/or other cognitive domain abnormalities lasting for at least 3 months) with a MoCA score of 10-22.
- Routine, consistent medication for 4 weeks or more.
Exclusion Criteria19
- 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.
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Interventions
Participants in active group will receive iTBS stimulation in 50-Hz triplets at 5 Hz for 600 seconds per session (2 seconds on and 8 seconds off) at 90% of their resting motor threshold to the left dorsolateral prefrontal cortex (DLPFC).Each intervention day includes 4 sessions (1800 pulses/session) of stimulation delivering a total of 7200 active pulses. This treatment protocol will be conducted 15 consecutive days.
Participants in the sham group will receive sham iTBS stimulation, which will use the same stimulation parameters, dosage, and duration as the active group, but will employ a sham coil. The sham coil is identical in appearance to the real stimulus coil and simulate the sound of a real stimulus, but do not produce a real stimulus.
Locations(1)
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NCT06579664