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NOT YET RECRUITING
NCT07891650
NA

Personalized Intermittent Theta Burst Stimulation for Cognitive Impairment Related to Cerebral Small Vessel Disease

Sponsor: Xuanwu Hospital, Beijing

View on ClinicalTrials.gov

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

DEVICE

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.

DEVICE

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