fMRI Evaluation of Auricular Acupuncture Targets: An Exploratory Clinical Study

NCT07332962 | Recruiting

• 1 other identifier: LSKY 2025-175-01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Participants

Keywords

fMRI; clinical trial; functional connectivity; auricular press needles

Outcome Measures

Primary Outcomes (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

  From enrollment to the end of treatment at 2 weeks

Secondary Outcomes (4)

• 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

Study Arms (2)

The experimental group used disposable sterile auricular press needles

EXPERIMENTAL

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 COMPARATOR

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

Interventions

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.

The control group received a needle-free, disposable, sterile auricular press needles.

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.

The experimental group used disposable sterile auricular press needles

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu Taizhou People's Hospital: lead

Study Sites (1)

Taizhou People's Hospital affiliated to Nanjing Medical University

Taizhou, Jiangsu, 225300, China

RECRUITING

Related Publications (11)

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  PMID: 12204303 BACKGROUND

• 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.

  PMID: 40629377 BACKGROUND

• 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.

  PMID: 37333617 BACKGROUND

• 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.

  PMID: 34623769 BACKGROUND

• 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.

  PMID: 26351510 BACKGROUND

• 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.

  PMID: 26546644 BACKGROUND

• 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.

  PMID: 21448381 BACKGROUND

• 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.

  PMID: 38883138 BACKGROUND

• 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.

  PMID: 32472196 BACKGROUND

• 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.

  PMID: 38032640 BACKGROUND

• 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.

  PMID: 38963749 BACKGROUND

Related Links

• Related Info

MeSH Terms

Interventions

Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The deputy dean of the hospital

Study Record Dates

• First Submitted: December 13, 2025
• First Posted: January 12, 2026
• Study Start: December 20, 2025
• Primary Completion: January 15, 2026
• Study Completion: January 30, 2026
• Last Updated: January 12, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)