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

ConditionsCerebral Small Vessel Diseases Cognitive Impairment

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age45-80

SponsorBeijing Tiantan Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Age 45-80 years old, with no limitation on sex.

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

iTBS
Device
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.
sham iTBS
Device
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.

Treatment groups

58 Participants

are divided into 2 treatment groups

Group A: iTBS groupActive comparator 1 intervention

Group B: sham iTBS groupSham comparator 1 intervention

Trial outcomes

Primary outcomes

Change from baseline in Montreal Cognitive Assessment Scale

Montreal Cognitive Assessment Scale (Beijing Edition) scores from 0 to 30. A higher score indicates better cognitive function.

Time frame