Cerebral Response of Healthy Subjects to a Somatosensory Stimulation With XNKQ Acupuncture Compared to Control Interventions Measured With EEG and fMRI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Change in brain background rhythms (mu-alpha and beta activity) [assessed using EEG and MRI] after one intervention (baseline vs. post stimulation) in comparison between the four different interventions.
研究概览
简要总结
The investigators will use EEG, structural MRI, and resting-state functional connectivity MRI to assess neuronal responses in 28 healthy subjects to different somatosensory stimulations.
详细描述
To develop a better understanding of the cerebral response to a complex somatosensory intervention with XNKQ acupuncture and to build a foundation for future studies with stroke patients our study aims to evaluate changes of brain activity and brain structure in healthy subjects after XNKQ acupuncture in comparison to three control interventions. We will use EEG, structural MRI, and resting-state functional connectivity MRI to assess neuronal responses in 28 healthy subjects to a) strong manual needle-stimulation of the acupuncture points DU26, PC6 and SP6 (XNKQ acupuncture), b) insertion of needles on the acupuncture points DU26, PC6 and SP6 without stimulation (control 1), c) strong manual needle stimulation of three non-acupuncture points (control 2), and d) insertion of needles on three non-acupuncture points without stimulation (control 3). With this, our study aims to create results which inform future studies in patients and might be helpful for the rehabilitation of deficits after stroke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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 (18 to 40 years of age) health status confirmed by a comprehensive neurological examination
- •Right-handed (evaluated by "the Edinburgh inventory")
- •Informed consent
- •No acupuncture treatment in the last 12 months
- •No medical knowledge about acupuncture
排除标准
- •History of neurological and/or psychiatric diseases
- •History of brain injury
- •Cognitive handicap and severe speech disorder
- •alcohol or drug abuse
- •History of neurosurgical intervention
- •Chronic disease (e.g., asthma, diabetes mellitus etc.) with regular use of medications
- •Usage of acute medication
- •Pregnancy (tested by urine pregnancy test before the measurement) or planned pregnancy
- •Any contraindication for acupuncture (e.g., anti-coagulation therapy)
- •Any exclusion criteria for MRI scanning (metal implants (e.g. pacemaker), claustrophobia, etc.)
- •Participation in another interventional trial.
结局指标
主要结局
Change in brain background rhythms (mu-alpha and beta activity) [assessed using EEG and MRI] after one intervention (baseline vs. post stimulation) in comparison between the four different interventions.
时间窗: 60 minutes
Changes in resting state functional connectivity [assessed using EEG and MRI] after one intervention (baseline vs. post-stimulation) in comparison between the four different interventions
时间窗: 60 minutes
次要结局
未报告次要终点
研究者
Claudia M. Witt
Professor
Charite University, Berlin, Germany