Actively Recruiting
Intermittent Theta Burst Stimulation on Cognitive Impairment of Cerebral Small Vessel Disease
Led by Beijing Tiantan Hospital · Updated on 2025-09-08
58
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating cerebral small vessel diseases (CSVD), which damage small brain vessels and can cause serious, lasting cognitive problems. This study aims to explore the feasibility, safety, and effects of intermittent Theta Burst Stimulation (iTBS) on cognitive impairment caused by CSVD. Current treatments for vascular cognitive impairment (VCI) are limited, so this trial evaluates a new noninvasive brain stimulation method guided by personalized brain mapping. Participants are randomly assigned to receive either active iTBS or sham iTBS treatment over three weeks. The active iTBS involves stimulating the left dorsolateral prefrontal cortex with specific pulse patterns multiple times per day, while the sham group receives a similar procedure without real stimulation. Both groups continue with standard treatment and management throughout. Follow-up assessments occur at baseline, around 15 days, and 90 days after the intervention. During the study, participants undergo cognitive tests including the Montreal Cognitive Assessment scale to measure changes in thinking abilities. Other assessments include memory, verbal fluency, anxiety, depression, sleep quality, physical performance, and walking tests. Researchers monitor outcomes at specified intervals to evaluate the safety and effects of iTBS on cognitive function in CSVD patients. The study lasts about three months per participant with face-to-face visits for evaluation.
CONDITIONS
Brief Title
Intermittent Theta Burst Stimulation on Cognitive Impairment of Cerebral Small Vessel Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 45 to 80 years, any sex
- Clinical evidence of cerebral small vessel disease confirmed by MRI or stroke syndrome
- Independence in daily life with modified Rankin Scale score of 2 or less
- Mild vascular cognitive impairment lasting 3 months or more with MoCA score between 10 and 22
- Consistent medication use for 4 weeks or longer
You will not qualify if you...
- Stroke within the last 30 days or large cerebral infarction
- History of cerebral cortex infarction
- Cerebrovascular malformations or untreated aneurysms larger than 3 mm
- Carotid or vertebral artery stenosis greater than 50%
- Possible amyloid cerebrovascular disease with multiple brain hemorrhagic lesions
- Diagnosis of neurodegenerative diseases like Alzheimer's or Parkinson's
- Non-vasogenic white matter diseases such as multiple sclerosis
- Other psychiatric disorders or suicidal intent
- Unable to tolerate or contraindicated for MRI
- Focal brain injury on MRI
- History of seizures in participant or first-degree relatives
- Implanted metal medical devices like pacemakers
- Transcranial magnetic stimulation therapy within past 3 months
- Severe organic diseases with life expectancy under 5 years
- Women who are pregnant, breastfeeding, or of childbearing potential
- Communication difficulties preventing cooperation
- History of alcohol or drug abuse
- Unable to complete follow-up visits
- Participation in other clinical trials currently or recently
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 weeks
Participants receive intermittent theta burst stimulation (iTBS) or sham stimulation to the left dorsolateral prefrontal cortex for 15 consecutive days.
Daily visits for 15 consecutive days
Duration - Approximately 3 months
Participants attend face-to-face interviews to assess cognitive function and other outcomes after the intervention.
2 visits at about 15 days and 90 days after intervention
Trial Site Locations
Total: 1 location
1
Beijing Tiantan Hospital
Beijing, China
Actively Recruiting
Research Team
W
Weiqi Chen
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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