Efficacy and Safety of rTMS for Cognitive Rehabilitation in Moyamoya Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 主要终点
- Neurocognitive outcomes at 3 months follow-up after TMS
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of transcranial magnetic stimulation (TMS) therapy in moyamoya patients who received surgical revascularization.
详细描述
Primary Outcome Measures:
TMS stimulation applied to the left DLPFC has a quantifiable effect on cognition [ Time Frame: Neuropsychological Assessments: Baseline（7days after STA-MCA bypass surgery）; 2 months after TMS treatment Changes in one or more assessed cognitive domains at baseline will be measured by comparing the scores for the different neuropsychological tests.
Secondary Outcome Measures:
Change in structural grey and white matter in the brain at baseline compared to after TMS stimulation [ Time Frame: MRI: Baseline and two months after TMS stimulation ] MRI analysis will measure any changes in cortical thickness (mm) or other structural changes in the brain after TMS or Sham-TMS stimulation
Change in executive functioning measured as resting-state functional MRI (fMRI) sequence [ Time Frame: MRI: Baseline and two months after TMS stimulation ] fMRI analysis will measure any changes in amplitude of low frequency fluctuation(ALFF) and other functional changes after TMS stimulation compared to baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •right-handed Chinese population aged 18-80 years;
- •No evidence of infarct in the cerebral cortex, basal ganglia, brainstem, or cerebellum, but small patches of hyper intense signal neither larger than the arbitrary cut off of 8 mm in maximum dimension on T2-weighted MR images no cystic in the cerebral subcortical white matter could be involved;
- •No evidence of intracerebral hemorrhage;
- •diagnosis through digital subtraction angiography;
- •physically capable of cognitive evaluation;
- •absence of significant psychiatric disorders or neurological diseases;
- •No evidence of perioperative epilepsy.
排除标准
- •Significant neurological diseases or psychiatric disorders that could affect cognition
- •Other cerebrovascular diseases (such as atherosclerosis or vasculitides) likely to cause focal cerebral ischemia
- •Concomitant cerebrovascular diseases (such as aneurysms or arteriovenous malformation) that need surgical intervention
- •Severe systemic diseases pregnant or perinatal stage women
- •Any diseases likely to death within 2 years
- •Taking drugs such as benzodiazepine clonazepam
- •Allergy to iodine or radiographic contrast media
- •Concurrent participation in any other experimental treatment trial
研究组 & 干预措施
TMS
The Transcranial Magnetic Stimulation course consisted of daily sessions of 2,000 stimuli for the left DLPFC (50 trains of 40 stimuli at 10 Hz for 10 days),
干预措施: Transcranial Magnetic Stimulation (Device)
SHAM
The patient is treated with Sham-TMS stimulation according to protocol with an inactive coil. The sham coil looks and sounds just like the real coil, but produces a negligible magnetic field.
干预措施: Sham Transcranial Magnetic Stimulation (Device)
结局指标
主要结局
Neurocognitive outcomes at 3 months follow-up after TMS
时间窗: 3 months
Measure neurocognitive outcomes using Mini-mental State Examination (MMSE)
次要结局
- Change in structural imaging in the brain at baseline compared to after TMS stimulation(3 months)
- Change in functional imaging in the brain at baseline compaired to after TMS stimulation(3 month)