NCT05578183撤回不适用
Therapeutic Efficacy and Mechanism of Personalized Theta Burst Stimulation on Working Memory Impairment in Patients After Stroke
China Rehabilitation Research Center1 个研究点 分布在 1 个国家开始时间: 2022年12月31日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Change from Baseline Montreal Cognitive Assessment scale
研究概览
简要总结
The goal of this clinical trial is to test the therapeutic effect of theta burst stimulation (TBS), which is one of stimulus pattern of repetitive transcranial magnetic stimulation, in patients with post stroke cognition impairment (PSCI). The main questions it aims to answer are:
- To explore the therapeutic effect of TBS to patients with PSCI.
- To compare effect of TBS with different dose.
- To explore the mechanism of TBS by functional magnetic resonance imaging (fMRI).
Participants will be asked to do:
- Treated with TBS and cognitive training for 3 weeks (15 days).
- Assessed with several scales, including Mini-mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), Loewenstein Occupational Therapy Cognitive Assessment (LOTCA), Wechsler Adult Intelligence Scale-revised in China (WAIS-RC), Wechsler Memory Scale (WMS) before and after treatment.
- Perform the resting fMRI, electroencephalogram (EEG) and event related potential before and after treatment.
Researchers will compare high-dose group, low-dose group and sham group to see if TBS play a role in PSCI and if the effect of high dose TBS was stronger than low dose.
详细描述
the procedure of study
- Patients were recruited and agreed with Informed Consent.
- All patients were assessed with MMSE, MoCA, LOTCA, WAIS and WMS, meanwhile they conduct fMRI and EEG. Target of TBS set at dorsolateral prefrontal cortex (DLPFC).
- TBS was performed for 15 days (5 days * 3 weeks).
- Within 3 days after TBS, all patients were assessed with MMSE, MoCA, LOTCA, WAIS and WMS, meanwhile they conduct fMRI and EEG.
- Data acquisition and analysis.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First-time stroke patients, meeting the diagnostic criteria set by the Fourth National Conference of Cerebrovascular Diseases in 1995, and the course of stroke
- •range from 1 to 12 months;
- •The vital signs are stable and no progress in neurological signs;
- •Education level: Primary school or above, and meeting one of the following conditions: MMSE scale ≥ 10 points, and indicating memory decline, with digit span or delayed memory defects.
- •Patients or their family members sign the informed consent form.
排除标准
- •Contraindications or high risks for TBS, such as epilepsy, intracranial metal implants, skull repair;
- •Contraindications for fMRI, such as metal implants or claustrophobia; refuse fMRI;
- •drug/alcohol dependence;
- •Cognition or memory dysfunction before the onset;
- •Patients who refuse to cooperate, or can't complete cognitive assessment due to other reasons, such as visual and auditory disturbance, aphasia, agnosia, apraxia.
结局指标
主要结局
Change from Baseline Montreal Cognitive Assessment scale
时间窗: 1. finished in 3 days before TBS stimulation. 2. finished in 3 days after stimulation.
one of the most used scales to assess cognition and screen person with cognitive impairment in the world. The minimum and maximum values range from 0 to 30. Higher score means better cognition level.
次要结局
- Change from Baseline Mini-mental State Examination scale(1. finished in 3 days before TBS stimulation. 2. finished in 3 days after stimulation.)
研究者
Hao Zhang
Professor
China Rehabilitation Research Center
研究点 (1)
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