Effects of High-frequency Repetitive Transcranial Magnetic Stimulation on Cerebral Autoregulation in Patients With Cerebral Small Vessel Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- phase difference (PD) in degree
研究概览
简要总结
The purpose of this study was to investigate the effect of high-frequency repetitive transcranial magnetic stimulation on cerebral autoregulation in patients with cerebral small vessel disease.
详细描述
Current studies have shown that repetitive transcranial magnetic stimulation can change the excitability of nerve cells, improve intracerebral artery blood supply, and even reduce the degree of neurological impairment in patients with stroke. The purpose of this study was to investigate the effect of high-frequency repetitive transcranial magnetic stimulation on cerebral autoregulation in patients with cerebral small vessel disease.
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)
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
- •Age 18-80 years, regardless of gender;
- •Diagnosed with CSVD, and neuroimaging presented as recent small subcortical infarcts;
- •Initiated transcranial magnetic stimulation within 7 days of onset;
- •Subject or legal representative agreed to the treatment and signed the informed consent;
排除标准
- •Vascular stenosis > 50% diagnosed by Transcranial Doppler (TCD) and carotid ultrasound;
- •Previous history of atrial fibrillation or myocardial infarction within 6 months;
- •Moyamoya disease or hereditary cerebral small vessel disease, such as CADASIL;
- •White matter hyperintensities (WMH) of non-vascular origin;
- •Severe hepatic and renal diseases, cancer or other major diseases related to integral medical and surgical procedures;
- •Patients with contraindications to transcranial magnetic stimulation, such as metal or electronic devices in the brain;
- •Pregnant or breastfeeding women;
- •The patients with disorders of consciousness, agitation or insufficient bilateral temporal bone windows for insonation who cannot cooperate to dynamic cerebral autoregulation monitoring;
- •Previous history of epilepsy or family history of epilepsy;
- •Previous treatment with transcranial magnetic stimulation or its equivalent;
- •Unwillingness to be followed up or poor adherence to treatment;
- •Those who are participating in other clinical investigators, or who have participated in other clinical studies within 3 months prior to enrollment, or who have participated in this study;
- •Other conditions that the investigators deemed unsuitable for enrollment.
研究组 & 干预措施
rTMS
Patients are treated with repetitive transcranial magnetic stimulation (rTMS).
干预措施: Repetitive transcranial magnetic stimulation (Procedure)
sham-rTMS
Patients are treated with sham repetitive transcranial magnetic stimulation (sham-rTMS).
干预措施: Sham repetitive transcranial magnetic stimulation (Procedure)
结局指标
主要结局
phase difference (PD) in degree
时间窗: 0-5 days
A cerebral autoregulation parameter derived from transfer function analysis. Continuous cerebral blood flow velocities of bilateral middle cerebral artery will be assessed noninvasively using transcranial Doppler. Spontaneous arterial blood pressure will be simultaneously recorded using a servo-controlled plethysmograph on the left or right middle finger with an appropriate finger cuff size. Transfer function analysis will be used to derive the cerebral autoregulatory parameter.
次要结局
未报告次要终点
研究者
Yi Yang
Vice President of First Hospital of Jilin University
The First Hospital of Jilin University