Auricular Press-Needle Acupuncture Induces Specific Brain Functional Reorganization and Modulates Autonomic Nervous Activity: A Randomized Sham-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Functional connectivity strength between the insula and the medial prefrontal cortex (MPFC)(T1-T0)
研究概览
简要总结
This study employs resting-state functional magnetic resonance imaging (rs-fMRI) to examine whether auricular press needles acupuncture modulates functional connectivity between the insula and medial prefrontal cortex (MPFC), in a manner comparable to transcranial vagus nerve stimulation (taVNS), and to assess its association with interoceptive improvement. By establishing a neurophysiological baseline for auricular vagus nerve stimulation (aVNS) in the healthy brain, the research aims to clarify its regulatory mechanisms in cognition and emotion. The findings provide a key theoretical and evaluative framework for translating aVNS into clinical applications for insomnia and depression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-30 years;
- •Basically normal diet and sleep;
- •No history of mental illness;
- •No MRI contraindications (e.g., metal implants or pacemakers) or claustrophobia；
- •Willing to participate in this study and sign the informed consent form.
排除标准
- •Presence of auricular skin lesions or allergy to adhesive ear patches;
- •Currently receiving regular acupuncture treatment;
- •History of bleeding disorders or anticoagulant use (increased bleeding risk);
- •Previous history of syncope during acupuncture.
研究组 & 干预措施
The experimental group used disposable sterile auricular press needles
干预措施: Effect of Verum Auricular Acupuncture on Resting-State Brain Function in Healthy Subjects: A Functional Magnetic Resonance Imaging (fMRI) Study (Device)
The control group received a needle-free, disposable, sterile auricular press needles.
干预措施: Sham Auricular Acupuncture as a Control Intervention for Brain fMRI Studies in Healthy Volunteers (Device)
结局指标
主要结局
Functional connectivity strength between the insula and the medial prefrontal cortex (MPFC)(T1-T0)
时间窗: From enrollment to the end of treatment at 2 weeks
Data collection is divided into two stages: Baseline : Collection of demographic data, baseline fMRI scan, and clinical assessment(T0). post-intervention : fMRI scan and clinical assessment immediately after the intervention(T1). The functional connectivity between the bilateral insula and medial prefrontal cortex was quantified by calculating the Pearson correlation of their mean time series at baseline and post-intervention. This connectivity strength serves as a proxy for the efficiency of information exchange between the interoceptive hub and the self-referential/emotion-regulatory hub. An increase following auricular acupuncture may reflect enhanced psychosomatic integration and top-down emotional regulation, suggesting a functional optimization of this circuit. Conversely, a decrease could indicate a disruption of pathological hyper-connectivity related to emotional constraint or an upregulation of control-mechanisms consistent with the observed alleviation of emotional symptoms
Functional connectivity strength between the insula and the medial prefrontal cortex (MPFC)(T1-T0)
时间窗: From enrollment to the end of treatment at 2 weeks
Data collection is divided into two stages: Baseline : Collection of demographic data, baseline fMRI scan, and clinical assessment(T0). post-intervention : fMRI scan and clinical assessment immediately after the intervention(T1). The functional connectivity between the bilateral insula and medial prefrontal cortex was quantified by calculating the Pearson correlation of their mean time series at baseline and post-intervention. This connectivity strength serves as a proxy for the efficiency of information exchange between the interoceptive hub and the self-referential/emotion-regulatory hub. An increase following auricular acupuncture may reflect enhanced psychosomatic integration and top-down emotional regulation, suggesting a functional optimization of this circuit. Conversely, a decrease could indicate a disruption of pathological hyper-connectivity related to emotional constraint or an upregulation of control-mechanisms consistent with the observed alleviation of emotional symptoms
次要结局
- Local brain activity indicators:regional homogeneity (ReHo)（T1-T0）(From enrollment to the end of treatment at 2 weeks)
- Local brain activity indicators:amplitude of low-frequency fluctuation (ALFF)（T1-T0）(From enrollment to the end of treatment at 2 weeks)
- Local brain activity indicators:fractional amplitude of low-frequency fluctuation (fALFF)（T1-T0）(From enrollment to the end of treatment at 2 weeks)
- Interhemispheric coordination index: voxel-mirrored homotopic connectivity (VMHC)（T0-T1）(From enrollment to the end of treatment at 2 weeks)
- Local brain activity indicators:regional homogeneity (ReHo)（T1-T0）(From enrollment to the end of treatment at 2 weeks)
- Local brain activity indicators:amplitude of low-frequency fluctuation (ALFF)（T1-T0）(From enrollment to the end of treatment at 2 weeks)
- Local brain activity indicators:fractional amplitude of low-frequency fluctuation (fALFF)（T1-T0）(From enrollment to the end of treatment at 2 weeks)
- Interhemispheric coordination index: voxel-mirrored homotopic connectivity (VMHC)（T0-T1）(From enrollment to the end of treatment at 2 weeks)
研究者
Ming Chu
The deputy dean of the hospital
Jiangsu Taizhou People's Hospital