Brain Activity Changes Measured by EEG and fMRI on Healthy Volunteers After Complex Somatosensory Stimulation With Acupuncture Needles
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in brain background rhythms after stimulation (baseline vs. post stimulation) in comparison between the three different point locations.
研究概览
简要总结
The purpose of this study is to evaluate effects on the brain after complex somatosensory stimulation with acupuncture needle. EEG and fMRI measurements will be performed.
详细描述
The aim of the study is to evaluate whether the point locations chosen for a complex somatosensory stimulation with acupuncture needles have an essential impact on the change of brain activity in healthy volunteers. For this, the investigators compare three different point locations (one acupuncture point and two non-acupuncture points) stimulated with acupuncture needles. Two measurements each with 20 subjects are planned.
- With the EEG measurements the impact of the stimulation's location on background rhythm especially in the somatosensoric cortex is evaluated.
- With the fMRI (functional magnetic resonance imaging) measurements the impact of the stimulation's location on BOLD (Blood Oxygen Level Dependency) signals and on functional connectivity is evaluated.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy subjects of age from 18 to 40 years (inclusive)
- •right-handed (evaluated by "The Edinburgh Inventory")
- •with informed consent signed
- •no acupuncture treatment in the last 12 months
- •no medical knowledge about acupuncture
- •free time to take part in the measurements
排除标准
- •history of neurological and/or psychiatric diseases
- •history of brain injury
- •cognitive handicap, severe speech disorder, alcohol or drug abuse
- •history of neurosurgical intervention
- •chronic disease (e.g., asthma, diabetes mellitus etc.) with regular use of medications
- •pregnancy (tested by urine pregnancy test before the measurement) or planned pregnancy
- •any contraindication for acupuncture (e.g., anti-coagulation therapy)
- •Additional exclusion criteria for fMRI measurement:
- •any contraindication for MRI (e.g., pacemaker, claustrophobia, cochlear implant, metallic implants etc. )
结局指标
主要结局
Change in brain background rhythms after stimulation (baseline vs. post stimulation) in comparison between the three different point locations.
时间窗: 26 minutes
Changes in resting state functional connectivity after stimulation (baseline vs. post-stimulation) in comparison between the three different point locations
时间窗: 1 hour
次要结局
未报告次要终点
研究者
Claudia M. Witt
Prof. Dr. med.
Charite University, Berlin, Germany