Real-time Monitoring of Motor Cortical Activity Induced by Low-frequency Repetitive Transcranial Magnetic Stimulation: Functional Near Infrared Spectroscopic Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Changes of Cortical activation
研究概览
简要总结
In this study, we investigated the effect of low-frequency repetitive trans cranial magnetic stimulation, one of the noninvasive brain stimuli, on the functional changes of the bilateral motor cortical activity in normal subjects using functional near infrared spectroscopy (fNIRS).
详细描述
In normal subjects,
- the effect of low-frequency repetitive transcranial magnetic stimulation on cerebral cortex are measured in real time using fNIRS.
- Changes in cerebral cortical activity before and after stimulation are measured using the motor function test and the motor-induced potential test
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult men and women without history of central nervous system disease and abnormalities
排除标准
- •Under 18 years old, 70 years old or older
- •A person who has inserted a metal object in a skull
- •A person with complete occlusion of the carotid artery
- •A person with epilepsy
- •Pregnant and lactating women
- •Who is not eligible for the test
研究组 & 干预措施
Navigated low frequency rTMS
Application of 1Hz low frequency repetitive transcranial magnetic stimulation to the primary motor area of the dominant hemisphere using a navigation system.
Using the BrainSight instrument, a navigation system, the TMS coil position can be fixed on the point precise target area based on the subject's MRI image.
干预措施: low frequency rTMS + Navigation System (Device)
only low frequency rTMS(not using Navigation System)
Application of low frequency repetitive transcranial magnetic stimulation to the primary motor area of the dominant hemisphere not using a navigation system.
TMS coil is fixed on the target area based on MEP hotspot.
干预措施: only low frequency rTMS (Device)
Navigated Sham rTMS
Application of repetitive transcranial magnetic stimulation with sham mode(no stimulation) to the primary motor area of the dominant hemisphere using a navigation system.
Using the BrainSight instrument, a navigation system, the TMS coil position can be fixed on the point precise target area based on the subject's MRI image.
Sham stimulation is stimulated by the same frequency, intensity and time as the actual stimulus in such a way that the 8-shaped coil is placed at a 90 degree angle to the scalp in the same manner as rTMS and sounds are heard but the magnetic stimulus is not transmitted to the cerebrum
干预措施: Sham low frequency rTMS + Navigation System (Device)
结局指标
主要结局
Changes of Cortical activation
时间窗: Baseline and after intervention[Immediately after 20 minutes of intervention]
Cortical activation is measured by functional Near-Infrared-Spectroscopy (fNIRS) (NIRScout, NIRx, Germany) before and after stimulation
次要结局
- changes in nine hole peg test(Baseline and after intervention[Immediately after 20 minutes of intervention])
- Sequential motor task(Baseline and after intervention[Immediately after 20 minutes of intervention])
- Changes in motor evoked potentia(Baseline and after intervention[Immediately after 20 minutes of intervention])
研究者
Yun-Hee Kim
Professor, MD, PhD
Samsung Medical Center