Remote Ischemic Preconditioning for Subcortical Vascular Dementia
试验速览
- 阶段
- 不适用
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Cognitive impairment assessment scale-SDMT
研究概览
简要总结
The purpose of this study is to determine whether the remote ischemic preconditioning are effective in the treatment of mild to moderate vascular dementia.
详细描述
In this randomized, double-blind, placebo-controlled trial, the investigators enrolled 52 participants aged 50-80 years. The participants had a diagnosis of subcortical vascular dementia at the neurology department of Tianjin medical university general hospital. Inclusion criteria included a clinical dementia rating 1-2; a mini-mental state examination score 15-26; and brain magnetic resonance imaging consistent with subcortical ischemic small vessel disease. All participants received standard medical management.Participants in the remote ischemic preconditioning group underwent 5 brief cycles consisting of bilateral upper limb ischemia followed by reperfusion. The remote ischemic precondition procedure was performed once daily over 180 consecutive days. Cognitive impairment assessment scale ( Hopkins Verbal Learning Test,HVLT;Symbol digital modalities tes,SDMT;judgement line orientation, JLO;trail making test A and B,TMT-A/B;chinese word fluency test;Activity of Daily Living Scale,ADL;Neuropsychiatric Inventory,NPI), serological inflammatory markers:hypersensitive C-reactive protein（hs-CRP）、plasma tumor necrosis factor-α(TNF-α)、interleukin-1β(IL-1β)、interleukin-6 (IL-6)、α1-antichymotrypsin),and MRI diffusion tensor imaging, DTI were compared with the untreated control group.
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
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of vascular dementia
- •In three months without cerebral infarction
- •MMSE 15 to 26 points;CDR 1-2 points;MoCA < 26 points
- •MRI showed subcortical ischemic cerebrovascular disease.
排除标准
- •AD 、 FTD, DLB and other causes of dementia.
- •Cortical/subcortical infarction
- •Cortex watershed infarction
- •Cerebral hemorrhage
- •Hydrocephalus
- •Other special causes of white matter lesions such as multiple sclerosis, sarcoidosis, radiation encephalopathy, etc.
- •Cannot complete aphasia neuropsychological assessment.
- •Genetic or inflammatory small vascular disease.
- •Serious cardiovascular, lung, liver, kidney, endocrine, such as infection disease.
- •Alcohol poisoning;
- •Hypothyroidism
- •Schizophrenia;Hamilton depression rating scale > 17 points.
- •Can not complete MRI.
结局指标
主要结局
Cognitive impairment assessment scale-SDMT
时间窗: At the first day/sixth month after randomization
Comparing two groups of participants score changes in-attention.
Cognitive impairment assessment scale-HVLT
时间窗: At the first day/sixth month after randomization
Comparing two groups of participants score changes in Short-term auditory verbal memory、learning rate and learning strategies.
Cognitive impairment assessment scale-TMT
时间窗: At the first day/sixth month after randomization
Comparing two groups of participants score changes in this test.This test reflects notice, order, mental flexibility, visual search and motor function, and set transfer (set shifting), at the same time reflect the hand-eye coordination, spatial perception and pay attention to ability.
Cognitive impairment assessment scale-NPI
时间窗: At the first day/sixth month after randomization
Comparing two groups of participants score changes in mental behavior symptoms.
Cognitive impairment assessment scale-JLO
时间窗: At the first day/sixth month after randomization
Comparing two groups of participants score changes in spatial perception and orientation ability.
Cognitive impairment assessment scale-ADL
时间窗: At the first day/sixth month after randomization
Comparing two groups of participants score changes in daily life ability.
Cognitive impairment assessment scale-Chinese auditory learning test
时间窗: At the first day/sixth month after randomization
Comparing two groups of participants score changes in speech ACTS and breadth of knowledge.
次要结局
- Serological inflammatory markers-TNF-a(At the fist day/sixth month after randomization)
- Serological inflammatory markers-IL - 1b(At the fist day/sixth month after randomization)
- Imaging markers-Routine MRI(At the fist day/sixth month after randomization)
- Serological inflammatory markers-IL - 6(At the fist day/sixth month after randomization)
- Imaging markers-DTI(At the fist day/sixth month after randomization)
- Serological inflammatory markers-hs-CRP(At the fist day/sixth month after randomization)
- Serological inflammatory markers-ACT(At the fist day/sixth month after randomization)
研究者
Junwei Hao
Professor
Tianjin Medical University General Hospital