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Healthy ParticipantsNCT07332962

fMRI Evaluation of Auricular Acupuncture Targets: An Exploratory Clinical Study

A study testing Effect of Verum Auricular Acupuncture on Resting-State Brain Function in Healthy Subjects: A Functional Magnetic Resonance Imaging (fMRI) Study in people with Healthy Participants, run by Jiangsu Taizhou People's Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 30 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Participants
What is being tested?
Effect of Verum Auricular Acupuncture on Resting-State Brain Function in Healthy Subjects: A Functional Magnetic Resonance Imaging (fMRI) Study
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteChina
Study dates
20 Dec 2025to 1 Mar 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Taizhou People's Hospital affiliated to Nanjing Medical University

    Taizhou, Jiangsu, 225300

Other trials in China

About this study

Official title: 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.

Being tested
Effect of Verum Auricular Acupuncture on Resting-State Brain Function in Healthy Subjects: A Functional Magnetic Resonance Imaging (fMRI) Study, Sham Auricular Acupuncture as a Control Intervention for Brain fMRI Studies in Healthy Volunteers
Keywords
fMRI, clinical trial, functional connectivity, auricular press needles

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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 VolunteersDevice

    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.

Study groups in NCT07332962
Study groupRoleWhat they receive
The experimental group used disposable sterile auricular press needlesExperimentalNot described
Receives: Device: Effect of Verum Auricular Acupuncture on Resting-State Brain Function in Healthy Subjects: A Functional Magnetic Resonance Imaging (fMRI) Study
The control group received a needle-free, disposable, sterile auricular press needles.Sham comparatorNot described
Receives: Device: Sham Auricular Acupuncture as a Control Intervention for Brain fMRI Studies in Healthy Volunteers

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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

    Measured: From enrollment to the end of treatment at 2 weeks

Secondary outcomes (4)
  1. Local brain activity indicators:regional homogeneity (ReHo)(T1-T0)

    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.

    Measured: From enrollment to the end of treatment at 2 weeks

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

    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.

    Measured: From enrollment to the end of treatment at 2 weeks

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

    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.

    Measured: From enrollment to the end of treatment at 2 weeks

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

    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.

    Measured: From enrollment to the end of treatment at 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2026
  2. Study start20 Dec 2025
  3. Primary completion30 Dec 2025
  4. Study completion1 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07332962
Sponsor's protocol ID
LSKY 2025-175-01
Status last verified
Dec 2025
First submitted
13 Dec 2025
Last updated
20 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • Desmond JE, Glover GH. Estimating sample size in functional MRI (fMRI) neuroimaging studies: statistical power analyses. J Neurosci Methods. 2002 Aug 30;118(2):115-28. doi: 10.1016/s0165-0270(02)00121-8.

    PubMed 12204303
  • Qi M, Huang Y, Mai R, Yan Z, Xu B, Liu B, Zhang Y. Baseline functional connectivity of the basal forebrain-cortical circuit predict taVNS treatment response in primary insomnia: a randomized controlled trial and fMRI study. BMC Med. 2025 Jul 9;23(1):412. doi: 10.1186/s12916-025-04126-7.

    PubMed 40629377
  • Huang Y, Zhang Y, Hodges S, Li H, Yan Z, Liu X, Hou X, Chen W, Chai-Zhang T, Kong J, Liu B. The modulation effects of repeated transcutaneous auricular vagus nerve stimulation on the functional connectivity of key brainstem regions along the vagus nerve pathway in migraine patients. Front Mol Neurosci. 2023 Jun 2;16:1160006. doi: 10.3389/fnmol.2023.1160006. eCollection 2023.

    PubMed 37333617
  • Zhang S, He JK, Meng H, Zhao B, Zhao YN, Wang Y, Li SY, Wang L, Wu MZ, Chen Y, Xiao X, Hou LW, Fang JL, Rong PJ. Effects of transcutaneous auricular vagus nerve stimulation on brain functional connectivity of medial prefrontal cortex in patients with primary insomnia. Anat Rec (Hoboken). 2021 Nov;304(11):2426-2435. doi: 10.1002/ar.24785. Epub 2021 Oct 8.

    PubMed 34623769
  • Ferreira LA, Grossmann E, Januzzi E, Goncalves RT, Mares FA, de Paula MV, Carvalho AC. Ear Acupuncture Therapy for Masticatory Myofascial and Temporomandibular Pain: A Controlled Clinical Trial. Evid Based Complement Alternat Med. 2015;2015:342507. doi: 10.1155/2015/342507. Epub 2015 Aug 17.

    PubMed 26351510
  • Moss DA, Crawford P. Ear Acupuncture for Acute Sore Throat: A Randomized Controlled Trial. J Am Board Fam Med. 2015 Nov-Dec;28(6):697-705. doi: 10.3122/jabfm.2015.06.150014.

    PubMed 26546644
  • Wu S, Liang J, Zhu X, Liu X, Miao D. Comparing the treatment effectiveness of body acupuncture and auricular acupuncture in preoperative anxiety treatment. J Res Med Sci. 2011 Jan;16(1):39-42.

    PubMed 21448381
  • Uddin N, Levine DL. Battlefield Acupuncture for the Treatment of Chronic Migraines. Cureus. 2024 May 15;16(5):e60369. doi: 10.7759/cureus.60369. eCollection 2024 May.

    PubMed 38883138
  • Natbony LR, Zhang N. Acupuncture for Migraine: a Review of the Data and Clinical Insights. Curr Pain Headache Rep. 2020 May 29;24(7):32. doi: 10.1007/s11916-020-00864-w.

    PubMed 32472196
  • de Oliveira Rodrigues DM, Menezes PR, Machado Ribeiro Silotto AE, Heps A, Pereira Sanches NM, Schveitzer MC, Faisal-Cury A. Efficacy and Safety of Auricular Acupuncture for Depression: A Randomized Clinical Trial. JAMA Netw Open. 2023 Nov 1;6(11):e2345138. doi: 10.1001/jamanetworkopen.2023.45138.

    PubMed 38032640
  • Zhang Y, Lin P, Wang R, Zhou J, Xu X, Jiang W, Pu X, Ge S. Insula-Medial Prefrontal Cortex Functional Connectivity Modulated by Transcutaneous Auricular Vagus Nerve Stimulation: An fMRI Study. IEEE J Biomed Health Inform. 2024 Oct;28(10):5962-5970. doi: 10.1109/JBHI.2024.3423019. Epub 2024 Oct 3.

    PubMed 38963749

Questions about this trial

What is this clinical trial studying?

A study testing Effect of Verum Auricular Acupuncture on Resting-State Brain Function in Healthy Subjects: A Functional Magnetic Resonance Imaging (fMRI) Study in people with Healthy Participants, run by Jiangsu Taizhou People's Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07332962, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.

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