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临床试验/NCT04492917
NCT04492917已完成不适用

The Effect of CV4 and Sacral Technique on the Alpha Bands Power: A Randomized Controlled Trial

Istituto Superiore di Osteopatia di Milano2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2018年9月10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
46
试验地点
2
主要终点
Alpha EEG

研究概览

简要总结

Compression of the fourth ventricle (CV4), is the most studied cranial technique, commonly used by Osteopathy in Cranial Field practitioners. Evidence attributed to CV4 some effects on nervous system functions, however, the supporting evidence for CV4 clinical benefits is promising but still poor. The osteopathic tradition considers the sacrum linked to the cranium through anatomical and functional connections. To our knowledge, no studies explored the potential effect of a sacral technique on brain activity as an indicator of a neurophysiological connection between the occiput and sacrum. This study aims to explore this effect by measuring the alpha-band activity during the application of a sacral technique (ST) compared to the CV4 application.

详细描述

Forty healthy volunteers will receive a combination of CV4 technique, CV4 sham, sacral technique (ST) and sacral sham technique (sST).

Each session, split by a 4-hour washout, will start with 10 min of no treatment (resting state), followed by two randomized interventions. Alpha EEG will be continuously recorded during each intervention and 10 min after, for a total of approximately 50-60 min per session.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects had to sleep for at least 6 hours the night before the experiment

排除标准

  • Use of Psychoactive or Psychotropic Substances
  • Cerebrovascular diseases
  • Recent headaches
  • Use of nicotine in the 24 hours prior to the quantitative EEG registration
  • Use of alcohol in the previous 12 hours.

结局指标

主要结局

Alpha EEG

时间窗: 50 minutes

Quantitative EEG recording of alpha wave (8-12Hz)

次要结局

未报告次要终点

研究者

发起方
Istituto Superiore di Osteopatia di Milano
申办方类型
Other
责任方
Principal Investigator
主要研究者

Viviana Pisa

Principal Investigator

Istituto Superiore di Osteopatia di Milano

研究点 (2)

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