fMRI Evaluation of Auricular Acupuncture Targets: An Exploratory Clinical Study
NCT ID: NCT07332962
Last Updated: 2026-01-12
Study Results
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Basic Information
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RECRUITING
NA
32 participants
INTERVENTIONAL
2025-12-20
2026-01-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
TRIPLE
Study Groups
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The experimental group used 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
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 control group received a needle-free, disposable, sterile auricular press needles.
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.
Interventions
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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 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.
Eligibility Criteria
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Inclusion Criteria
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
2. Currently receiving regular acupuncture treatment;
3. History of bleeding disorders or anticoagulant use (increased bleeding risk);
4. Previous history of syncope during acupuncture.
18 Years
30 Years
ALL
Yes
Sponsors
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Jiangsu Taizhou People's Hospital
OTHER
Responsible Party
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Ming Chu
The deputy dean of the hospital
Locations
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Taizhou People's Hospital affiliated to Nanjing Medical University
Taizhou, Jiangsu, China
Countries
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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Other Identifiers
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LSKY 2025-175-01
Identifier Type: -
Identifier Source: org_study_id
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