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Completed

NCT Number: NCT07332962

fMRI Evaluation of Auricular Acupuncture Targets: An Exploratory Clinical Study

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.

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Key information

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taizhou People's Hospital affiliated to Nanjing Medical University

Taizhou, Jiangsu, 225300, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Effect of Verum Auricular Acupuncture on Resting-State Brain Function in Healthy Subjects: A Functional Magnetic Resonance Imaging (fMRI) Study

Device

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.

Sham Auricular Acupuncture as a Control Intervention for Brain fMRI Studies in Healthy Volunteers

Device

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.

Primary outcomes

  1. Functional connectivity strength between the insula and the medial prefrontal cortex (MPFC)(T1-T0)

    Time frame: 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 outcomes

  1. Local brain activity indicators:regional homogeneity (ReHo)(T1-T0)

    Time frame: 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.

  2. Local brain activity indicators:amplitude of low-frequency fluctuation (ALFF)(T1-T0)

    Time frame: 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.

  3. Local brain activity indicators:fractional amplitude of low-frequency fluctuation (fALFF)(T1-T0)

    Time frame: 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.

  4. Interhemispheric coordination index: voxel-mirrored homotopic connectivity (VMHC)(T0-T1)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Jiangsu Taizhou People's Hospital

Other

Registry information

Official study title

Auricular Press-Needle Acupuncture Induces Specific Brain Functional Reorganization and Modulates Autonomic Nervous Activity: A Randomized Sham-Controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jan 12, 2026
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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