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临床试验/NCT05915923
NCT05915923招募中不适用

Effect of Transcranial Magnetic Stimulation on Dynamic Cerebral Autoregulation in Healthy Adults

Yi Yang1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年8月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
90
试验地点
1
主要终点
The differences of phase difference (PD) at 30 minutes after transcranial magnetic stimulation under different stimulation modes (1Hz, 10 Hz, sham stimulation).

研究概览

简要总结

The purpose of this study is to determine the effect of transcranial magnetic stimulation with different stimulation modes ( 1Hz, 10Hz, sham stimulation ) on cerebral autoregulation.

详细描述

Current studies have shown that repetitive transcranial magnetic stimulation (TMS) 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.Dynamic cerebral autoregulation (dCA), refers to a complex process in which small intracranial arteries contract or relax to maintain relatively stable cerebral blood volume when systemic arterial blood pressure changes, which can predict the prognosis of patients with ischemic stroke. In this study, we hypothesis that TMS provides neuro-protection by means of improving dCA.

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 (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 59 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age≥18 years, < 60 years, both genders;
  • Willing to participate and sign the informed consent;
  • Bilateral temporal windows were well penetrated;

排除标准

  • Complaints of previous or existing chronic organic diseases ( stroke, Parkinson 's disease, hypertension, diabetes, etc. ), mental diseases ( bipolar disorder, personality disorder, schizophrenia, etc. ), or cognitive impairment;
  • Suffering from infectious diseases in late one month;
  • Pregnancy or breast-feeding;
  • Sleep disorders, anxiety and depression,
  • Alcohol or drug abuse;
  • History of prescription drugs or over-the-counter (OTC) drugs in the past 2 weeks;
  • History of epilepsy or family history of epilepsy;
  • Implants ( stents or metals );
  • Other conditions that the researchers think are not suitable for the project.

研究组 & 干预措施

Low-frequency rTMS Group

Experimental

Healthy adults treated with 1Hz repetitive transcranial magnetic stimulation (rTMS)

干预措施: 1 Hz Repetitive transcranial magnetic stimulation (Procedure)

High-frequency rTMS Group

Experimental

Healthy adults treated with 10Hz repetitive transcranial magnetic stimulation (rTMS)

干预措施: 10 Hz Repetitive transcranial magnetic stimulation (Procedure)

Control group

Sham Comparator

The Control group received rTMS with sham transcranial magnetic stimulation (sham-rTMS)

干预措施: Sham Repetitive transcranial magnetic stimulation (Procedure)

结局指标

主要结局

The differences of phase difference (PD) at 30 minutes after transcranial magnetic stimulation under different stimulation modes (1Hz, 10 Hz, sham stimulation).

时间窗: 0-30minutes

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

  • To compare the difference of phase difference (PD) at 1hour, 6hours and 24hours after transcranial magnetic stimulation under different stimulation modes (1Hz, 10Hz, sham stimulation).(0-1hour; 0-6hours; 0-24hours)

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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