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

Launched by BEIJING TIANTAN HOSPITAL · Aug 28, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a treatment called intermittent Theta Burst Stimulation (iTBS) to see if it can help improve thinking and memory problems caused by cerebral small vessel diseases (CSVD). CSVD can lead to significant cognitive impairment, which means difficulties with thinking and memory. The researchers want to find out if iTBS is safe, effective, and feasible for people suffering from these cognitive issues.

To participate in this study, individuals must be between 45 and 80 years old and have a diagnosis of CSVD, which can be confirmed through certain brain imaging tests. They should have mild cognitive impairment and be able to live independently. Participants will not be eligible if they have had a stroke recently, have certain brain conditions, or are unable to tolerate MRI scans. If eligible, participants can expect to receive the treatment and be monitored throughout the study to assess its effects on their cognitive abilities. This research aims to provide new hope for those struggling with cognitive issues related to cerebral small vessel diseases.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria：
• • 1. Age 45-80 years old, with no limitation on sex.
• 2. Clinical evidence of CVSD as evidenced by one or more of:
• • White matter hyperintensity with Fazekas score ≥2
• • a lacunar stroke syndrome (e.g. pure motor stroke, pure sensory stroke, sensorimotor stroke, ataxic hemiparesis, or clumsy hand dysarthria syndrome) with a corresponding acute lacunar infarct on diffusion weighted imaging (DWl) for cases imaged (clinically) within 3 weeks of stroke or anatomically compatible lacunar infarct on fluid attenuated inversion recovery (FLAIR)/T1 MRI for cases imaged later after stroke (diameter≤1.5cm).
• • 3. Independence of daily life (modified Rankin Scale score ≤2).
• • 4. Mild vascular cognitive impairment (memory and/or other cognitive domain abnormalities lasting for at least 3 months) with a MoCA score of 10-22.
• • 5. Routine, consistent medication for 4 weeks or more.
• Exclusion Criteria:
• • 1. History of stroke within previous 30 days, including cerebral infarction (diameter \>15mm), cerebral hemorrhage, subarachnoid hemorrhage;
• • 2. History of cerebral cortex infarction.
• • 3. History of cerebrovascular malformation or aneurysmal subarachnoid hemorrhage, or discovery of an untreated aneurysm \> 3mm.
• • 4. Carotid or vertebral artery stenosis \> 50% measured on North American Symptomatic Carotid Endarterectomy Trial (NASCET) criteria.
• • 5. Possible amyloid cerebrovascular disease with at least 2 lobar hemorrhagic lesions (i.e., intracranial hemorrhage, cerebral microbleeds (CMB), cortical superficial siderosis, or convexal subarachnoid hemorrhage) measured on Boston Criteria 2.0; Or at least one lobar hemorrhagic lesion and at least one white matter feature (severe enlarged perivascular space in the centrum semiovale or multiple punctate white matter hyperintensities) without deep hemorrhagic lesion (cerebral hemorrhage or CMB) on T2\* weighted MRI.
• • 6. Recorded diagnosis of neurodegenerative diseases (e.g. Alzheimer's disease and Parkinson's disease).
• • 7. Definite non-vasogenic white matter lesions (e.g. multiple sclerosis, cortical dysplasia in adults, metabolic encephalopathy).
• • 8. Other psychiatric disorders diagnosed measured on the Diagnostic and Statistical Manual of Mental Disorders - V (DSM-V) diagnostic criteria; Or apparent suicidal intent.
• • 9. Unable to tolerate MRI or contraindication to MRI (e.g., claustrophobia).
• • 10. T1 or T2 weighted MRI shows focal brain injury.
• • 11. Patients or first-degree relatives with a history of seizures.
• • 12. Implanted pacemakers, vagus nerve stimulators, deep brain stimulators, or other metal medical devices.
• • 13. Received transcranial magnetic stimulation therapy within previous 3 months.
• • 14. Severe organic diseases with expected survival time \<5 years, such as malignant tumor.
• • 15. Women of child bearing potential, pregnant or breastfeeding.
• • 16. Individual who have difficulty communicating verbally to the extent that they are unable to communicate, understand or follow instructions normally, and are unable to cooperate with treatment and evaluation.
• • 17. Combined with alcohol and drug abuse history.
• • 18. Unable to be cooperative and complete the follow-up due to geographical or other reasons.
• • 19. Participated in other clinical trials.