Healthy Participants
Conditions
Keywords
fMRI, clinical trial, functional connectivity, auricular press needles
Brief summary
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.
Interventions
DEVICEEffect of Verum Auricular Acupuncture on Resting-State Brain Function in Healthy Subjects: A Functional Magnetic Resonance Imaging (fMRI) Study
The auricular points Heart, Kidney, Shenmen, and Subcortex were selected. After a baseline fMRI scan, sterile press needles were applied aseptically to these points in the experimental group.Each point was stimulated with 20 manual presses per session. This procedure was repeated for three sessions, separated by 10-minute intervals, resulting in a total intervention time of approximately 26 minutes. To capture immediate neural effects, a post-intervention fMRI scan was conducted to observe changes in brain activity. The intervention involved applying auricular press needles (a type of intradermal embedding needle) to specific acupoints.
DEVICESham Auricular Acupuncture as a Control Intervention for Brain fMRI Studies in Healthy Volunteers
The sham auricular acupuncture control group was identical to the experimental group in terms of acupoint locations, auricular acupuncture procedure, and fMRI scanning protocol. The sole exception was that the sham group received a needle-free, auricular press needles.
Sponsors
Jiangsu Taizhou People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age 18-30 years; 2. Basically normal diet and sleep; 3. No history of mental illness; 4. No MRI contraindications (e.g., metal implants or pacemakers) or claustrophobia； 5. Willing to participate in this study and sign the informed consent form.
Exclusion criteria
1. Presence of auricular skin lesions or allergy to adhesive ear patches; 2. Currently receiving regular acupuncture treatment; 3. History of bleeding disorders or anticoagulant use (increased bleeding risk); 4. Previous history of syncope during acupuncture.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional connectivity strength between the insula and the medial prefrontal cortex (MPFC)(T1-T0) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Local brain activity indicators:regional homogeneity (ReHo)（T1-T0） | From enrollment to the end of treatment at 2 weeks | Regional homogeneity (ReHo) was calculated as Kendall's coefficient of concordance between each voxel and its 26 nearest neighbors, assessed separately before and after the intervention. This metric captures the temporal synchrony of neural activity within local brain regions. Following auricular acupuncture, increased ReHo in regions such as the insula and prefrontal cortex may reflect improved neural coordination and functional integration. Conversely, decreased ReHo in specific areas could indicate a modulatory effect on abnormally elevated local synchrony. |
| Local brain activity indicators:amplitude of low-frequency fluctuation (ALFF)（T1-T0） | From enrollment to the end of treatment at 2 weeks | Amplitude of low-frequency fluctuation (ALFF) was quantified by calculating the square root of the power spectrum within the 0.01-0.08 Hz frequency band of the BOLD signal, followed by normalization to the global mean ALFF value. This metric reflects the intensity of spontaneous neural activity in the brain. An increase in ALFF within emotion- and cognition-related regions following auricular acupuncture may indicate an elevation in baseline neural activity or metabolic activity in these areas. Conversely, a decrease in ALFF in regions such as the limbic system could reflect an inhibitory modulatory effect of the intervention on hyperactivity, potentially contributing to emotional stabilization. |
| Local brain activity indicators:fractional amplitude of low-frequency fluctuation (fALFF)（T1-T0） | From enrollment to the end of treatment at 2 weeks | Fractional amplitude of low-frequency fluctuation (fALFF) was quantified by calculating the ratio of low-frequency ALFF to the full-frequency ALFF before and after the intervention, followed by normalization to the global mean fALFF value. Changes in fALFF following the intervention allow a more specific assessment of auricular acupuncture's regulatory effects on intrinsic neural oscillations related to cognition and emotion. When interpreted in conjunction with ALFF changes, the direction of fALFF alteration can help elucidate the specific mechanisms through which auricular acupuncture modulates neural activity patterns. |
| Interhemispheric coordination index: voxel-mirrored homotopic connectivity (VMHC)（T0-T1） | From enrollment to the end of treatment at 2 weeks | Voxel-Mirrored Homotopic Connectivity (VMHC) was assessed by calculating the Pearson correlation coefficient between BOLD time series from symmetrically corresponding voxel pairs in the left and right hemispheres, separately before and after the intervention. The VMHC value quantifies the functional coordination between homotopic regions across the two cerebral hemispheres. Following auricular acupuncture, enhanced VMHC in regions associated with emotional regulation and cognitive control, such as the prefrontal cortex and anterior cingulate cortex, may suggest improved interhemispheric balance and integration of emotional processing. Conversely, changes in VMHC within specific regions could help clarify how the intervention modulates functional imbalances between hemispheres, particularly those related to constrained emotional states. |
Countries
China
Outcome results
None listed