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New treatment option for Cerebral Small Vessel Diseases
Official title Intermittent Theta Burst Stimulation on Cognitive Impairment of Cerebral Small Vessel Disease
ClinicalTrials.gov ID: NCT06579664
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 80
You may be able to join if
- Age 45-80 years old, with no limitation on sex.
- 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)...
- Independence of daily life (modified Rankin Scale score ≤2).
You likely can't join if
- History of stroke within previous 30 days, including cerebral infarction (diameter \>15mm), cerebral hemorrhage, subarachnoid hemorrhage;
- History of cerebral cortex infarction.
- History of cerebrovascular malformation or aneurysmal subarachnoid hemorrhage, or discovery of an untreated aneurysm \> 3mm.
- Carotid or vertebral artery stenosis \> 50% measured on North American Symptomatic Carotid Endarterectomy Trial (NASCET) criteria.
- Possible amyloid cerebrovascular disease with at least 2 lobar hemorrhagic lesions (i.e., intracranial hemorrhage, cerebral microbleeds (CMB)...
- Recorded diagnosis of neurodegenerative diseases (e.g. Alzheimer's disease and Parkinson's disease).
See the full eligibility criteria
- Age 45-80 years old, with no limitation on sex.
- 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...
- Independence of daily life (modified Rankin Scale score ≤2).
- Mild vascular cognitive impairment (memory and/or other cognitive domain abnormalities lasting for at least 3 months) with a MoCA score of 10-22.
- Routine, consistent medication for 4 weeks or more.
- History of stroke within previous 30 days, including cerebral infarction (diameter \>15mm), cerebral hemorrhage, subarachnoid hemorrhage;
- History of cerebral cortex infarction.
- History of cerebrovascular malformation or aneurysmal subarachnoid hemorrhage, or discovery of an untreated aneurysm \> 3mm.
- Carotid or vertebral artery stenosis \> 50% measured on North American Symptomatic Carotid Endarterectomy Trial (NASCET) criteria.
- 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)...
- Recorded diagnosis of neurodegenerative diseases (e.g. Alzheimer's disease and Parkinson's disease).
- Definite non-vasogenic white matter lesions (e.g. multiple sclerosis, cortical dysplasia in adults, metabolic encephalopathy).
- Other psychiatric disorders diagnosed measured on the Diagnostic and Statistical Manual of Mental Disorders - V (DSM-V) diagnostic criteria; Or apparent suicidal intent.
- Unable to tolerate MRI or contraindication to MRI (e.g., claustrophobia).
- T1 or T2 weighted MRI shows focal brain injury.
- Patients or first-degree relatives with a history of seizures.
- Implanted pacemakers, vagus nerve stimulators, deep brain stimulators, or other metal medical devices.
- Received transcranial magnetic stimulation therapy within previous 3 months.
- Severe organic diseases with expected survival time \<5 years, such as malignant tumor.
- Women of child bearing potential, pregnant or breastfeeding.
- 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.
- Combined with alcohol and drug abuse history.
- Unable to be cooperative and complete the follow-up due to geographical or other reasons.
- Participated in other clinical trials.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.