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临床试验/NCT05843240
NCT05843240已完成不适用

Effects of Repetitive Transcranial Magnetic Stimulation on Cerebral Autoregulation in Patients With Acute Ischemic Stroke

Yi Yang1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2023年5月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
128
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 repetitive transcranial magnetic stimulation on cerebral autoregulation in patients with acute ischemic stroke.

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 ischemic stroke. The purpose of this study was to investigate the effect of repetitive transcranial magnetic stimulation on cerebral autoregulation in patients with acute ischemic stroke.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years, both sexes;
  • Clinically definite diagnosis of acute ischemic stroke;
  • Baseline National Institute of Health Stroke Scale (NIHSS) score ≤25;
  • Pre-onset modified Rankin Scale (mRS) score ≤1;
  • Randomized and initiated transcranial magnetic stimulation within 1 week of onset;
  • Subject or legal representative agreed to the treatment and signed the informed consent.

排除标准

  • Presence of a medical condition such as severe cognitive impairment or mental impairment;
  • Patients with serious physical diseases or who have had craniocerebral surgery;
  • Previous history of epilepsy, family history of epilepsy or presence of seizure provoking factors;
  • Pregnancy or breastfeeding;
  • The presence of metal foreign bodies near the stimulation site, such as intracranial metal implants, cochlear implants, built-in pulse generators (brain pacemakers, cardiac pacemakers), etc.;
  • Patients who are unable to complete cerebral autoregulation, or bilateral temporal window penetration poorly;
  • life expectancy of ≤3 months or inability to complete the study for other reasons;
  • unwillingness to be followed up or poor treatment compliance;
  • 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.

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

发起方
Yi Yang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yi Yang

Vice President of First Hospital of Jilin University

The First Hospital of Jilin University

研究点 (1)

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