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临床试验/NCT04795024
NCT04795024已完成不适用

Effectiveness of Yamamoto's New Skull Acupuncture (YNSA) on Resting State Brain Networks

BDH-Klinik Hessisch Oldendorf1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2020年1月15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
28
试验地点
1
主要终点
Changed functional connectivity

研究概览

简要总结

This study investigates the effects of a new form of acupuncture (Yamamoto's New Skull Acupuncture [YNSA]) on resting-state brain networks. Therefore, two resting-state fMRI scans are measured (one without and one with acupuncture needles) in healthy adults. It is expected that acupuncture is associated with changes in functional connectivity within different brain networks.

详细描述

Although acupuncture has been used in China and Japan for over 2000 years, it has only become increasingly important in Western medicine in the last few decades. A special form of acupuncture is "Yamamoto's New Skull Acupuncture" (YNSA), which was developed by Toshikatsu Yamamoto. Here, the needling is limited to the skull.

Acupuncture is a safe and almost painless procedure that is usually well tolerated. One indication might be the therapy of neurological diseases. Schockert and colleagues examined the effectiveness of YNSA in a placebo-controlled study. To investigate the effectiveness of cranial acupuncture, three fMRI sequences were performed: 1) without acupuncture, 2) sham acupuncture (acupressure without needling) and 3) YNSA acupuncture. The subjects (17 stroke patients with right hemisphere lesions and 19 healthy controls) were instructed to alternately make a fist (3s) and close it again (2s). There were a total of five blocks, each with a duration of 120s. Compared to sham acupuncture, cortical activations in motor, premotor and supplementary motor areas were observed during YNSA acupuncture.

In contrast to Schockert and colleagues, the planned study uses resting-state fMRI to determine whether YNSA acupuncture is associated with changes of functional connectivity within different resting-state networks.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adults aged 18 to 65

排除标准

  • mental disorders (dementia, depression)
  • MRI contraindications
  • claustrophobia
  • weight > 120 kg

结局指标

主要结局

Changed functional connectivity

时间窗: 35 minutes

Functional connectivity is measured using resting-state fMRI.

次要结局

未报告次要终点

研究者

发起方
BDH-Klinik Hessisch Oldendorf
申办方类型
Other
责任方
Sponsor

研究点 (1)

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