Actively Recruiting

Phase Not Applicable
Age: 45Years - 80Years
All Genders
NCT06579664

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

92 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 45Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 45 and 80 years, any sex
  • Clinical evidence of cerebral small vessel disease shown by either white matter hyperintensity with Fazekas score 62
  • Lacunar stroke syndrome with corresponding acute or anatomically compatible lacunar infarct on MRI
  • Independence in daily life with modified Rankin Scale score 62
  • Mild vascular cognitive impairment lasting at least 3 months with MoCA score between 10 and 22
  • Stable, consistent medication use for 4 weeks or more
Not Eligible

You will not qualify if you...

  • Stroke within the past 30 days, including cerebral infarction larger than 15mm, cerebral hemorrhage, or subarachnoid hemorrhage
  • History of cerebral cortex infarction
  • Cerebrovascular malformation, aneurysmal subarachnoid hemorrhage, or untreated aneurysm larger than 3mm
  • Carotid or vertebral artery stenosis greater than 50% by NASCET criteria
  • Possible amyloid cerebrovascular disease with multiple lobar hemorrhagic lesions or white matter features without deep hemorrhagic lesions
  • Diagnosed neurodegenerative diseases such as Alzheimer's or Parkinson's disease
  • Non-vasogenic white matter lesions like multiple sclerosis or metabolic encephalopathy
  • Other psychiatric disorders or suicidal intent
  • Unable to tolerate or contraindicated for MRI
  • Focal brain injury shown on T1 or T2 weighted MRI
  • Seizure history in patient or first-degree relatives
  • Implanted pacemakers, vagus nerve stimulators, deep brain stimulators, or metal medical devices
  • Transcranial magnetic stimulation therapy received within previous 3 months
  • Severe organic diseases with expected survival less than 5 years
  • Women who are pregnant, breastfeeding, or of childbearing potential
  • Difficulty communicating or cooperating with treatment and evaluation
  • History of alcohol or drug abuse
  • Unable to complete follow-up due to geographic or other reasons
  • Participation in other clinical trials

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Beijing Tiantan Hospital

Beijing, China

Actively Recruiting

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Research Team

W

Weiqi Chen

CONTACT

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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