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Personalized Intermittent Theta Burst Stimulation for Cognitive Impairment Related to Cerebral Small Vessel Disease
Sponsor: Xuanwu Hospital, Beijing
Summary
This study will evaluate whether personalized intermittent theta burst stimulation (iTBS), a form of noninvasive transcranial magnetic stimulation, can safely improve cognitive function in people with cognitive impairment related to cerebral small vessel disease. The study will enroll 160 adults aged 45-85 years with mild cognitive impairment or mild vascular dementia related to cerebral small vessel disease. Participants will be randomly assigned in equal numbers to receive active iTBS or sham stimulation. Brain magnetic resonance imaging (MRI) will be used to identify an individualized stimulation target in the left prefrontal cortex. Sham stimulation will mimic the treatment experience without delivering effective magnetic stimulation. Participants and outcome assessors will not know which treatment participants receive. Treatment will last 24 weeks. Participants will receive four stimulation sessions per day for five consecutive days during the first week, followed by four sessions on one day each week during weeks 2-24. Cognitive assessments will be performed before treatment, during treatment, at the end of treatment, and three months after treatment ends. The main outcome is the change in Montreal Cognitive Assessment (MoCA) score from baseline to week 24. Brain MRI, electroencephalography (EEG), and adverse event monitoring will be used to examine changes in brain function and treatment safety.
Official title: Personalized Intermittent Theta Burst Stimulation for Cognitive Impairment Related to Cerebral Small Vessel Disease: A Randomized, Double-Blind, Sham-Controlled Clinical Trial
Key Details
Gender
All
Age Range
45 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
160
Start Date
2026-10
Completion Date
2027-12
Last Updated
2026-10-23
Healthy Volunteers
No
Interventions
Active Personalized Intermittent Theta Burst Stimulation
Active intermittent theta burst stimulation (iTBS) will target the individualized left dorsolateral prefrontal cortex site selected using resting-state functional MRI connectivity with the frontoparietal network and neuronavigation. Intensity will be 80-100% of the resting motor threshold, adjusted for tolerability. Each session will deliver 1,800 pulses using three-pulse bursts at 50 Hz, repeated at 5 Hz, with 2-second stimulation trains and 8-second intervals. Four sessions will be administered per treatment day, with 50-60 minutes between sessions. Treatment will occur on five consecutive days in week 1 and on one day per week during weeks 2-24, totaling 112 sessions.
Sham Personalized Intermittent Theta Burst Stimulation
Sham stimulation will target the same individualized left dorsolateral prefrontal cortex site using a dedicated sham coil or sham mode. It will mimic the sounds, vibration, and procedures of active treatment without delivering effective magnetic stimulation. The treatment schedule will match the active intervention: four sessions per treatment day, with 50-60 minutes between sessions, on five consecutive days in week 1 and on one day per week during weeks 2-24, totaling 112 sessions.
Locations (3)
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Geriatric Hospital
Beijing, Beijing Municipality, China