NCT06252987招募中不适用
The Second Hospital of Dalian Medical University
The Second Affiliated Hospital of Dalian Medical University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Concentration of brain's HbO by functional near-infrared spectroscopy
研究概览
简要总结
If there is a comparison group: Researchers will compare [insert groups] to see if [insert effects]
The purpose of the clinical trial is to find a treatment for stroke patients with cognitive impairment, and the main questions it aims to answer are:
- [Search for effective treatments of cognitive impairment after stroke]
- [Explore brain network features with functional near-infrared spectroscopy] Participants will receive conventional treatment, tDCS treatment, or rTMS treatment, or tDCS-rTMS treatment.
And then compare cognitive function and brain function.
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
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the clinical diagnostic criteria of the Expert Consensus on the Management of Cognitive Impairment after Stroke in 2021;
- •30-80 years old, right-handed, unilateral hemiplegia;
- •Verbal expression can cooperate with the completion of the evaluation, sustained attention time is longer than 5 minutes;
- •Simple Mental State Examination Scale (MMSE) score ≤26 points; MoCA scale score < 26 points; Memory test (RMBT) score less than 21 points;
- •patients or their family agree to sign the informed consent;
- •The Ethics Committee approved the trial.
排除标准
- •Memory dysfunction caused by other diseases, such as Alzheimer's disease, lewy body dementia, pituitary tumor surgery, hypothyroidism, etc.;
- •There are contraindications of rTMS and tDCS for untreated intracranial aneurysms, severe epilepsy, intracranial metal, etc.
- •Patients with severe visual, cognitive or speech impairment who cannot cooperate with treatment;
- •The condition is not stable; Or other serious physical diseases.
结局指标
主要结局
Concentration of brain's HbO by functional near-infrared spectroscopy
时间窗: 2 weeks
fNIRS
次要结局
- Score of The Frontal Assessment Battery(2 weeks)
- Score of Mini-Mental State Examination(2 weeks)
- Score of Attention assessment by the digit span task(2 weeks)
研究者
研究点 (1)
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