An interventional study of Active Personalized Intermittent Theta Burst Stimulation and Sham Personalized Intermittent Theta Burst Stimulation in Cerebral Small Vessel Disease and Vascular Cognitive Impairment, sponsored by Xuanwu Hospital, Beijing. Not yet recruiting at 3 sites in China. Open to participants aged 45 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Xuanwu Hospital, Beijing · Not applicable, Interventional, and Treatment
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.
126 studies on the registry are indexed under Cerebral Small Vessel Diseases; 69 are open to participants now.
This study's planned enrollment of 160 is above the median of 88 across 73 interventional studies indexed under Cerebral Small Vessel Diseases.
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Participants will receive active personalized intermittent theta burst stimulation (iTBS) targeting the left dorsolateral prefrontal cortex, with the target individualized using resting-state functional MRI and neuronavigation. Treatment will last 24 weeks: four sessions per day for five consecutive days in week 1, followed by four sessions on one treatment day each week during weeks 2-24. Each session will deliver 1,800 pulses at 80-100% of the resting motor threshold, adjusted according to tolerability, with 50-60 minutes between sessions.
Device: Active Personalized Intermittent Theta Burst Stimulation
Participants will receive sham stimulation at the individualized left dorsolateral prefrontal cortex target using a dedicated sham coil or sham mode. Sham stimulation will mimic the sounds, vibration, and procedures of active treatment without delivering effective magnetic stimulation. The schedule will match the active group: four sessions per day for five consecutive days in week 1, followed by four sessions on one treatment day each week during weeks 2-24, with 50-60 minutes between sessions.
Device: Sham 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 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.
Change From Baseline in Montreal Cognitive Assessment (MoCA) Total Score at Week 24
The Montreal Cognitive Assessment (MoCA) assesses global cognitive function. Total scores range from 0 to 30, with higher scores indicating better cognitive function. Change will be calculated as the week 24 total score minus the baseline total score. A positive change indicates improvement.
Time frame: Baseline and week 24 (end of treatment)
Change From Baseline in Montreal Cognitive Assessment (MoCA) Total Score at Three Months After Treatment
The Montreal Cognitive Assessment (MoCA) assesses global cognitive function. Total scores range from 0 to 30, with higher scores indicating better cognitive function. Change will be calculated as the three-month post-treatment follow-up total score minus the baseline total score. A positive change indicates improvement.
Time frame: Baseline and three months after completion of the 24-week treatment period
Change From Baseline in Mini-Mental State Examination (MMSE) Total Score
The Mini-Mental State Examination (MMSE) assesses global cognitive function. Total scores range from 0 to 30, with higher scores indicating better cognitive function. Changes will be calculated separately as the total score at each post-baseline assessment minus the baseline total score. Positive changes indicate improvement.
Time frame: Baseline, week 24 (end of treatment), and three months after completion of treatment
Change From Baseline in Clinical Dementia Rating (CDR) Global Score
The Clinical Dementia Rating (CDR) global score assesses the severity of cognitive and functional impairment. Possible scores are 0, 0.5, 1, 2, and 3, with higher scores indicating greater impairment. Changes will be calculated separately as the global score at each post-baseline assessment minus the baseline global score. Negative changes indicate improvement.
Time frame: Baseline, week 24 (end of treatment), and three months after completion of treatment
Change From Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Score
The Clinical Dementia Rating-Sum of Boxes (CDR-SB) is calculated by summing ratings across six cognitive and functional domains. Scores range from 0 to 18, with higher scores indicating greater impairment. Changes will be calculated separately as the score at each post-baseline assessment minus the baseline score. Negative changes indicate improvement.
Time frame: Baseline, week 24 (end of treatment), and three months after completion of treatment
Change From Baseline in Activities of Daily Living (ADL) Score
Activities of daily living will be assessed using the ADL scale. Changes will be calculated separately as the score at each post-baseline assessment minus the baseline score.
Time frame: Baseline, week 24 (end of treatment), and three months after completion of treatment
Change From Baseline in Auditory Verbal Learning Test (AVLT) Scores
Verbal learning and memory will be assessed using the Auditory Verbal Learning Test (AVLT). Changes will be calculated separately as each prespecified AVLT score at each post-baseline assessment minus its corresponding baseline score.
Time frame: Baseline, week 24 (end of treatment), and three months after completion of treatment
Change From Baseline in Trail Making Test (TMT) Performance
Performance on the Trail Making Test (TMT) will be assessed. Changes will be calculated separately as the prespecified performance measure at each post-baseline assessment minus its corresponding baseline measure.
Time frame: Baseline, week 24 (end of treatment), and three months after completion of treatment
Change From Baseline in Digit Span Test (DST) Scores
Attention and working memory will be assessed using the Digit Span Test (DST). Changes will be calculated separately as each prespecified score at each post-baseline assessment minus its corresponding baseline score.
Time frame: Baseline, week 24 (end of treatment), and three months after completion of treatment
Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score
Neuropsychiatric symptoms will be assessed using the Neuropsychiatric Inventory (NPI). Changes will be calculated separately as the total score at each post-baseline assessment minus the baseline total score. Higher scores indicate more severe neuropsychiatric symptoms; negative changes indicate improvement.
Time frame: Baseline, week 24 (end of treatment), and three months after completion of treatment
Change From Baseline in Resting-State and Task-Related Electroencephalographic Measures
Changes in resting-state and task-related electroencephalographic measures will be assessed, including spectral power, functional connectivity, and cognitive event-related potentials. Each prespecified measure will be compared with its corresponding baseline value.
Time frame: Baseline, week 1 (end of induction), week 24 (end of treatment), and three months after completion of treatment
Change From Baseline in Multimodal Magnetic Resonance Imaging Measures
Changes in multimodal magnetic resonance imaging measures will be assessed to characterize brain network function and white matter microstructure. Each prespecified measure will be compared with its corresponding baseline value.
Time frame: Baseline, week 24 (end of treatment), and three months after completion of treatment
Plan to share: No — There is currently no plan to share individual participant data with other researchers.
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Start is estimated for Oct 2026; primary completion for Sep 2027, 11 months later.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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