fMRI Evaluation of Auricular Acupuncture Targets: An Exploratory Clinical Study

May 18, 2026 updated by: Ming Chu, Jiangsu Taizhou People's Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Taizhou, Jiangsu, China, 225300
        • Taizhou People's Hospital affiliated to Nanjing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The experimental group used disposable sterile auricular press needles
Device: Effect 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.
Sham Comparator: The control group received a needle-free, disposable, sterile auricular press needles.
Device: Sham 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From enrollment to the end of treatment at 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of treatment at 2 weeks
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.
From enrollment to the end of treatment at 2 weeks
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.
From enrollment to the end of treatment at 2 weeks
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.
From enrollment to the end of treatment at 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu Taizhou People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2025

Primary Completion (Actual)

December 30, 2025

Study Completion (Actual)

March 1, 2026

Study Registration Dates

First Submitted

December 13, 2025

First Submitted That Met QC Criteria

December 29, 2025

First Posted (Actual)

January 12, 2026

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LSKY 2025-175-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared publicly due to participant privacy/confidentiality restrictions and the terms of the informed consent obtained for this study. Summary data are available upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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