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Gallbladder meridian(GB) acupoints may play an important role in the treatment of major depressive disorder (MDD). Therefore, this study is designed to focus on the traditional Chinese medicine (TCM) theory of " gallbladder dominating decision ", take the GB as the entry point, and use functional Near-Infrared Spectroscopy(fNIRS) technology to observe the effect of intradermal acupuncture on the cerebral hemodynamic indexes of the prefrontal cortex and bilateral temporal cortex of patients with MDD.
This study will include 20 patients with MDD (observation group) and 20 healthy control participants without MDD (control group). fNIRS will be adopted to assess regional oxygen saturation of the blood in the MDD-related cerebral cortex: the prefrontal and bilateral temporal cortex. Based on the results of the fNIRS, to explore cerebral hemodynamic changes in the prefrontal and bilateral temporal cortex in patients with MDD. By observing the changes of hemodynamic characteristics of the prefrontal cortex and bilateral temporal cortex of the observation group and the control group during the course of intradermal acupuncture, explore the immediate response of the hemodynamic characteristics of the prefrontal cortex and bilateral temporal cortex of the observation group to the intervention of the GB acupoints.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observation group | Experimental | This group will include 20 patients with MDD. Before signal collection, the subject will wear a helmet embedded with numerous near-infrared light sensors, covering the prefrontal region and both temporal lobes. The whole process will be monitored in real time by fNIRS. During needle retention, participants will be asked to keep their eyes closed and quiet throughout the intervention and to avoid physical movement as much as possible. |
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| Control group | Other | This group will include 20 healthy control participants without MDD. Before signal collection, the subject will wear a helmet embedded with numerous near-infrared light sensors, covering the prefrontal region and both temporal lobes. The whole process will be monitored in real time by fNIRS. During needle retention, participants will be asked to keep their eyes closed and quiet throughout the intervention and to avoid physical movement as much as possible. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intradermal acupuncture | Procedure | Procedure/Surgery: Bilateral Fengchi(GB20)and Qiuxu(GB40) will be stimulated. According to the position of the acupoints, the needle of φ0.20*1.5mm will be chosen. After acupuncture point localization and routine disinfection, all subjects will receive the acupuncture in the same order, and follow the steps of "resting- stimulating-preparing-stimulating-resting" to complete the acupuncture operation alternately.Before acupuncture, rest for 60s as the baseline period, and then stimulate the bilateral Fengchi(GB20) for 2 mins. After stopping stimulation, wait for fNIRS to return to the resting level (i.e., the preparation period), then stimulate the bilateral Qiuxu(GB40) for another 2 mins, and stop the near-infrared scanning when the image of fNIRS returns to the resting level. |
| Measure | Description | Time Frame |
|---|---|---|
| total hemoglobin (Total-Hb) | Total hemoglobin was calculated using the combined concentrations of oxygenated hemoglobin and deoxygenated hemoglobin [Total-Hb = oxy-Hb + deoxy-Hb]. | During the whole acupuncture operation |
| oxygenated hemoglobin (oxy-Hb) | Oxygenated hemoglobin is the combination of hemoglobin plus oxygen. | During the whole acupuncture operation |
| deoxygenated hemoglobin (deoxy-Hb) | Deoxygenated hemoglobin is the unbound form of hemoglobin with oxygen. | During the whole acupuncture operation |
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Inclusion Criteria:
Inclusion criteria for control group:
Inclusion criteria for observation group:
Exclusion Criteria:
Exclusion criteria for control group:
Exclusion criteria for observation group:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaomei Shao, Ph.D | Contact | +8618957130287 | shaoxiaomei@zcmu.edu.cn | |
| Sangsang Xiong | Contact | +86152671382513 | 376815403@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaomei Shao, Ph.D | The Third Affiliated hospital of Zhejiang Chinese Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the Third affiliated hospital of Zhejiang Chinese Medical university [Recruiting] | Hangzhou | Zhejiang | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38059202 | Derived | Xiong S, Tu M, Wu X, Qu S, Chen N, Jin J, Rong H, Pei S, Fang J, Shao X. Real-Time Hemodynamic Changes in the Prefrontal and Bilateral Temporal Cortices During Intradermal Acupuncture for Major Depressive Disorder: A Prospective, Single-Center, Controlled Trial Protocol. Neuropsychiatr Dis Treat. 2023 Dec 1;19:2627-2638. doi: 10.2147/NDT.S435617. eCollection 2023. |
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|
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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