Efficacy of High-Frequency Repetitive Transcranial Magnetic Stimulation in Patients With Post-Stroke Cognitive Impairment: A Randomized Controlled Trial
概览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Montreal Cognitive Assessment
概览
简要总结
To clarify the clinical efficacy of high-frequency rTMS on patients with post-stroke cognitive impairment, fNIRS and EEG techniques were used to observe the changes in brain functional activities of patients with post-stroke cognitive impairment after rTMS treatment, and to clarify the neuroregulatory effect of rTMS on patients with post-stroke cognitive impairment.
详细描述
The experimental group will receive rTMS stimulation therapy, which involves applying high-frequency 10Hz rTMS to the patient's head for 20 minutes, once a day, for a total of 20 sessions. The control group will undergo rTMS sham stimulation therapy, using a sham stimulation coil to apply the same parameters and method of stimulation to the head. Although the sham stimulation coil has no difference in appearance and sound from the real stimulation coil, it cannot generate a real magnetic field to stimulate the brain. You need to be evaluated before the treatment begins, after 10 sessions, and 20 sessions of the treatment. The evaluation content includes: Researchers will use relevant clinical evaluation scales to conduct functional evaluations on you, and perform near-infrared and electroencephalogram brain imaging measurements.
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
- Double (Participant, Outcomes Assessor)
盲法说明
treatment implementers（repetitive transcranial magnetic stimulation）
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets the diagnostic criteria for stroke as stipulated in the "Guidelines for the Prevention and Treatment of Stroke in China (2021 Edition)", and the initial stroke diagnosis is confirmed by cranial CT or MRI examination, and is confirmed as the initial onset;
- •The disease course is 1-12 months;
- •Has cognitive impairment (MoCA \< 26 points, education years ≤ 12 years, add 1 point to the score result);
- •Age 35-75 years old, gender not limited;
- •Stable vital signs, no progressive neurological symptoms;
- •No severe aphasia, visual or auditory impairment, and able to complete the research protocol;
- •Not using antidepressant drugs simultaneously;
- •If using cognitive-improving drugs (such as donepezil, memantine), it should last for at least 3 weeks or more, and no dose adjustment will be made during the enrollment period;
- •Voluntarily participate and sign the informed consent form.
排除标准
- •Has a history of brain tumors, brain trauma, epilepsy or mental disorders;
- •Had cognitive impairment before the stroke;
- •Underwent craniotomy or had a skull defect;
- •Had implanted metal or electronic devices (such as cardiac pacemakers, cochlear implants, deep brain stimulators, aneurysm clips, internal fixation devices after ventriculoperitoneal shunt surgery, etc.);
- •Has other serious diseases that may affect the study;
- •Pregnant women
研究组 & 干预措施
the control group
The control group will undergo rTMS sham stimulation therapy combined with conventional rehabilitation treatment, using a sham stimulation coil.
干预措施: sham repetitive transcranial magnetic stimulation (Other)
The rTMS stimulation group
The experimental group will receive rTMS stimulation therapy, which involves applying high-frequency 10Hz rTMS to the patients' heads for 20 minutes, followed by conventional rehabilitation treatment.
干预措施: repetitive transcranial magnetic stimulation (Device)
结局指标
主要结局
Montreal Cognitive Assessment
时间窗: Baseline, Day 10, Day 20,Evaluate the Montreal Cognitive Assessment Scale, fNIRS, Symbol-Digit Substitution Test, Shape Linking Test, Pittsburgh Sleep Quality Index, Digit Span Test, Stroop Test, Fugl-Meyer Assessment, Hamilton Depression Scale, Hamilton
The total score of the Montreal Cognitive Assessment Scale (MoCA) is 30 points. The normal cut-off score is usually ≥ 26 points. To correct for the influence of educational level, if the educational duration of the subject is ≤ 12 years, 1 point will be added to their original score, with the maximum score remaining at 30 points.
次要结局
未报告次要终点
研究者
wangyonghui
Chief Physician
Qilu Hospital of Shandong University